Volume 38 • Number 1 March/April 2019 PracticalDiabetology · March/April 2019 Practical...

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Clinical Perspective SCREENING, DIAGNOSIS, AND MANAGEMENT OF TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS Alba Morales, MD, and Laura Hieronymus, DNP, MSEd, RN, MLDE, BC-ADM, CDE, FAADE Care of youth with T2DM is the aim of many research studies. More data are necessary to help determine strategies that provide optimal care for children and adolescents with the disorder. Meanwhile, close monitoring of overweight and obese pediatric patients’ glycemic status is essential. An early aggressive approach of lifestyle modification to try to prevent or delay T2DM should be considered. Technology DANA FOR DIVAS: INTEGRATING TECHNOLOGY INTO A DIABETES PRACTICE Nicola Davies, PhD Diabetes Advance Network Access (DANA) is designed to provide a one-stop site to navigate the plethora of information, news, training, supplies, product reviews, use cases, and other resources related to devices/apps for diabetes and prediabetes. IN SEARCH OF THE PERFECT CGM REPORT Gary Scheiner, MS, CDE; Reviewed by Alissa Heizler, MA, RD, CDE Adoption of continuous glucose monitors (CGMs) is growing rapidly among health-care providers and their patients. A multitude of systems are now available. Each system has its own report-generating software, and a number of “midware” programs can merge these data from multiple devices, including CGMs. Columns COMMENTARY Using Tandem’s Basal-IQ Technology with Your Patients The latest from Tandem Diabetes Care®, Basal-IQ™ Technology is a predictive low glucose suspend feature on the t:slim X2™ Insulin Pump that integrates with the Dexcom G6® Continuous Glucose Monitoring (CGM) System. JOURNAL WATCH This column highlights clinical trial data and landmark trials. Information for obtaining trial data and the references to the published articles are provided to facilitate discussion with your patients and colleagues. EDUCATOR’S CORNER Enterprising Diabetes Educators Embrace Digital Health The rapidly expanding role of digital health in diabetes care, the evidence advocating its use, and the leadership opportunity for diabetes educators is explored. Volume 38 • Number 1 March/April 2019 Practical Approaches to Diabetes and Related Diseases Practical Diabetology ® 2 6 8 14 15 Professional Supplement to 12

Transcript of Volume 38 • Number 1 March/April 2019 PracticalDiabetology · March/April 2019 Practical...

Clinical PerspectiveSCREENING, DIAGNOSIS, AND MANAGEMENT OF TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTSAlba Morales, MD, and Laura Hieronymus, DNP, MSEd, RN, MLDE, BC-ADM, CDE, FAADECare of youth with T2DM is the aim of many research studies. More data are necessary to help determine strategies that provide optimal care for children and adolescents with the disorder. Meanwhile, close monitoring of overweight and obese pediatric patients’ glycemic status is essential. An early aggressive approach of lifestyle modification to try to prevent or delay T2DM should be considered.

TechnologyDANA FOR DIVAS: INTEGRATING TECHNOLOGY INTO A DIABETES PRACTICENicola Davies, PhDDiabetes Advance Network Access (DANA) is designed to provide a one-stop site to navigate the plethora of information, news, training, supplies, product reviews, use cases, and other resources related to devices/apps for diabetes and prediabetes.

IN SEARCH OF THE PERFECT CGM REPORTGary Scheiner, MS, CDE; Reviewed by Alissa Heizler, MA, RD, CDEAdoption of continuous glucose monitors (CGMs) is growing rapidly among health-care providers and their patients. A multitude of systems are now available. Each system has its own report-generating software, and a number of “midware” programs can merge these data from multiple devices, including CGMs.

ColumnsCOMMENTARYUsing Tandem’s Basal-IQ Technology with Your PatientsThe latest from Tandem Diabetes Care®, Basal-IQ™ Technology is a predictive low glucose suspend feature on the t:slim X2™ Insulin Pump that integrates with the Dexcom G6® Continuous Glucose Monitoring (CGM) System.

JOURNAL WATCHThis column highlights clinical trial data and landmark trials. Information for obtaining trial data and the references to the published articles are provided to facilitate discussion with your patients and colleagues.

EDUCATOR’S CORNEREnterprising Diabetes Educators Embrace Digital HealthThe rapidly expanding role of digital health in diabetes care, the evidence advocating its use, and the leadership opportunity for diabetes educators is explored.

Volume 38 • Number 1March/April 2019

Practical Approaches to Diabetes and Related DiseasesPractical Diabetology

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EDITOR’S NOTEEDITORIALEditorLaura Hieronymus, DNP, MSEd, RN, MLDE, BC-ADM, CDE, FAADEAssociate Director, Education and Quality ServicesUK HealthCare Barnstable Brown Diabetes CenterUniversity of KentuckyLexington, KY

Editor, Educator’s CornerMeghan Jardine, MS, MBA, RDN, LD, CDE Associate Director of Diabetes Education, Physicians Committee for Responsible MedicineWashington, DC

Editorial Director, Wellness Maureen McCarthy

Senior Digital Editor Diane Fennell

Associate EditorsSandra Drozdz Burke, PhD, APRN, FAADE, FAAN Associate Professor (retired), University of Illinois at Chicago College of Nursing Chicago, IL

Robert “Bob” Chilton, DO Professor of Medicine, Division of Cardiology The University of Texas Health Science Center at San Antonio San Antonio, TX

Editorial BoardArnaud Bastien, MD Head of Clinical Research, Akros Pharma Inc., Magnolia, NJ

Jackie Boucher, MS, RDN President of Children’s HeartLink, Minneapolis, MN

Shana Cunningham, MSN, RN, MLDE, BC-ADM, CDE Diabetes Education Services Coordinator, University of Kentucky HealthCare Barnstable Brown Diabetes Center, Lexington, KY

Tammy DiMuzio, MS, RN, CDE Clinical Program Manager, Diabetes Center, Cincinnati Children's Hospital, Cincinnati, OH

Steven Edelman, MD Founder and Director, Taking Control of Your Diabetes, San Diego, CA

Marion J. Franz, MS, RDN, CDE Nutrition Concepts by Franz, Minneapolis, MN

Martha M. Funnell, MS, RN, CDE Medical School University of Michigan, Ann Arbor, MI

George Grunberger, MD, FACP, FACE Grunberger Diabetes Institute, Bloomfield Hills, MI

Alissa Heizler-Mendoza, MA, RDN, CDE Senior Director of Advocacy, Insulet Corporation, Newtown, CTRichard Hellman, MD, FACP, FACE Lawrence and Memorial Hospital, Waterford, CTRobert Ratner, MD MedStar Washington Hospital Center, Washington, DCNancy J. Rennert, MD, FACE, FACP Norwalk Community Health Center, Norwalk, CTJulio Rosenstock, MD Diabetes & Endocrine Center, Dallas, TXJane Jeffrie Seley, DNP, MPH, MSN, GNP, BC-ADM, CDE, FAADE Division of Endocrinology, Diabetes & Metabolism, Weill Cornell Medicine, New York, NYEvan Sisson, PharmD, MSHA, BCACP, CDE, FAADE Associate Professor, Department of Pharmacotherapy and Outcomes Science, Virginia Commonwealth University, Richmond, VASusan Weiner, MS, RDN, CDE, FAADE Owner, Susan Weiner Nutrition, PLLC Long Island, NYJoel Zonszein, MD Burke Rehabilitation Hospital and Montefiore Medical Center, Bronx, NY

PUBLISHING STAFFChairman & Chief Executive Officer Jeffrey C. WolkChief Operating Officer Peter MaddenSenior Vice President, Sales & Marketing Robin MorseVice President, Business Operations Courtney WhitakerAccounting Amanda Joyce, Tina McDermott, Wayne TuggleClient Services Supervisor Cheyenne CorlissSenior Client Services Associate Tou Zong HerClient Services Aubrie Britto, Darren Cormier, Andrea PalliArt Director Carolyn V. MarsdenGraphic Designers Jaron Cote, Allyson PrebleCopy Editor Suzanne FoxIn memory of Susan Fitzgerald, COO, 1966-2018 To submit a manuscript to this journal, email [email protected].

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“Change is inevitable. Change is constant.” Spoken by Benjamin Disraeli, a British Prime Minister in the 1800s, these words still ring true. Change is a constant in diabetes care and education. Embrace it!

Embrace technology. The field of diabetes technology is endlessly growing. In fact, the American Diabetes Association added a new section “Diabetes Technology” to the Standards of Medical Care in Diabetes—2019. Technology-enabled models using mobile health and telehealth to deliver care and education are on the rise. Such platforms can help us increase reach and potentially improve patient engagement. Use of patient-generated health data (PGHD) gathered from technology should be standard diabetes practice. Experts identify four key elements to employ a technology-enabled self-management feedback loop using digital technology: two-way communication, analysis of PGHD, customized self-management education, and individualized feedback. In this issue, learn from your peers’ experience in diabetes technology.

Embrace evidence. Data drive development and ongoing review of standards of medical care, practice guidelines, and expert consensus. Integrating medical and education strategies with basic and clinical research enhances the effectiveness and safety of patient care. Staying up to date with current evidence-based recommendations is a challenge, but essential for optimal diabetes outcomes. The number of children and adolescents with Type 2 diabetes is a growing health issue that demands our attention. The body of evidence is increasing; however, we are still learning. Sharing cases may help provide guidance on the use of standards of care as well as better understand this population.

Embrace change. Stay abreast of technology, consult with the evi-dence to shape your clinical and educational strategies, and share your experiences. Submit a manuscript for publication in Practical Diabetology to [email protected].

Editor Laura Hieronymus

Practical Diabetology • Vol. 38, No. 1 • March/April 20192

CLINICAL PERSPECTIVE

Table 1

Diagnosis of Prediabetes and Type 2 Diabetes

Blood Glucose Value Diagnosis

Fasting Plasma Glucose (FPG) < 100 mg/dL Normal

100-125 mg/dL Prediabetes

≥ 126 mg/dL Diabetes

OGTT: 2 hours post glucola (1.75 g /kg; max 75 g) < 140 mg/dL Normal

140-199 mg/d Prediabetes

≥ 200 mg/dl Diabetes

Hemoglobin A1c (HbA1c) HbA1c Value Diagnosis

< 5.7% Normal

5.7-6.4% Prediabetes

≥ 6.5% Diabetes

SCREENING, DIAGNOSIS, AND MANAGEMENT OF TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTSType 2 Diabetes in YouthType 2 diabetes (T2DM) in children and adoles-cents is on the rise. Experts estimate the incidence at ~5000 new cases annually in the U.S. Rates of T2DM in youth (<20 years old) are predicted to increase fourfold in the next 40 years.

In contrast with T2DM in adults, T2DM in pediatric patients is more aggressive and includes a more rapid decline in beta cell function and early development of comorbidities. Acceptable treatment options are limited to metformin and insulin, which may result in a less favorable response.

Screening Screening for T2DM in youth is recommended in asymptomatic pediatric patients (puberty or ≥10 years old to <18 years old) who are overweight (BMI >85th %) or obese (BMI >95th %) or when weight is 120% of ideal for height or for youth who have one or more of the following risk factors:

◆ maternal history of gestational diabetes during the child’s gestation;

◆ family history of T2DM in a primary (especially maternal) or secondary relative;

◆ Latino, Native American, African American, Asian American, or Pacific Islander descent; and/or

◆ signs of insulin resistance.

Acanthosis nigricans—a brownish-black vel-vety hyperpigmentation usually found in folds of the neck, the armpits, or groin—is a sign of insulin resistance. Additionally, conditions associated with insulin resistance that accentuate risk include car-diometabolic disorders such as dyslipidemia and hypertension, polycystic ovary syndrome, and small for gestational age birth weight.

If glycemic measurements are normal, screen-ing should occur a minimum of every three years.

PATIENT CASE: AM14 yo African-American female

• BMI 34 kg/m2 • Chronic obesity since age 7• Family history:

• T2DM (paternal); gestational diabe-tes (maternal)

• Current medications: • albuterol and budesonide (asthma

well controlled)• Height 5’6”• Weight 97 kg• B/P 120/75 mmHg• Severe acanthosis nigricans (neck, arm-

pits, knuckles)

Alba Morales, MD Physician specialist in pedi-atric endocrinology.

Laura Hieronymus, DNP, MSEd, RN, MLDE, BC-ADM, CDE, FAADEDoctor of nursing practice and master licensed dia-betes educator. She is the associate director.

Both are at the Barnstable Brown Diabetes Center at the University of Kentucky in Lexington, Kentucky.

Practical Diabetology • Vol. 38, No. 1 • March/April 2019 3

Visit PracticalDiabetology.com for more diabetes clinical news

More frequent screening should be considered if BMI is increasing.

Diagnosis About 40% of youth with prediabetes or T2DM have no symptoms. Fasting plasma glucose (FPG), or FPG and two-hour plasma glucose results during a 75-gram oral glucose tolerance test (OGTT), or hemoglobin A1c can be used to diagnose predia-betes or T2DM in pediatric patients (see Table 1). A combination of these methods of evaluation is commonly used in clinical practice. At onset of T2DM, approximately 6% of youth between 10 and 19 years old present with diabetic ketoacidosis (DKA) and diabetes-associated autoantibodies. Thus, all children with diabetes should be managed by a pediatric endocrinology team to ensure accurate diagnosis along with ongoing management based on current standards of care.

ManagementThe pediatric patient with diabetes should be fol-lowed by an interdisciplinary team that includes a diabetes care provider, diabetes nurse educators, a registered dietitian nutritionist (RDN), and a psy-chologist or social worker. A comprehensive diabetes management plan based on the American Associa-tion of Diabetes Educators Self-Care Behaviors™

(AADE7) is appropriate (Figure 1). The pediatric patient with T2DM—as well as the family—should receive diabetes self-management education and support (DSMES). DSMES should be culturally sensitive and consider day-to-day experiences to incorporate the diagnosis into the family dynamics.

Lifelong support for lifestyle modification should be part of the treatment plan for both prediabetes and T2DM. Like all children (with diabetes or not), a healthful eating pattern and optimal physical activity are encouraged. Emphasis on nutrient-dense, high quality foods is essential with a goal of 7 to 10 percent body weight reduction of excess weight. Taking care to avoid high calorie, poor nutrition choices should be encouraged. Preschool-aged children should be physi-cally active throughout the day to enhance growth and development. Recommendations for children and adolescents should include 60 minutes of moderate to intense physical activity daily with muscle- and bone- strength-based training at least three days weekly while minimizing inactive behavior.

Pharmacologic treatment should be initiated at diagnosis of T2DM and should be accompanied by lifestyle modification. Medication therapy should be individualized and adjusted to achieve optimal outcomes (see Table 2).

An A1C of <7.5% is recommended across all pediatric age groups. A lower goal of <7% may be a viable option if it can be achieved without unwar-ranted hypoglycemia. Self-monitoring of blood glu-cose (SMBG) is essential feedback on the treatment plan. For patients using basal insulin, fasting glucose values can be helpful in determining insulin adjust-ments. Postprandial blood glucose (BG) should be monitored if preprandial values and A1C levels conflict. When using intensive insulin therapy, fre-quent SMBG, i.e. before meals and bedtime should be performed.

Ongoing SMBG can help the patient, family, and diabetes care team assess the progression of the dis-ease. In addition to BG control, initial and ongoing management must include evaluation and treatment

PATIENT CASE: AMThree month follow-up:

• A1C: 7.1%• Weight 108 kg; BMI 37 kg/m2• Limited adherence to lifestyle modifica-

tion • Metformin 500 mg BID (titration to 1000

mg BID)• SMBG X1 daily, alternate fasting and

postprandial• Follow-up in three months

PATIENT CASE: AM• A1C 6.4%• OGTT Results:

• Fasting 102 mg/dl• Two hour 215 mg/dl

• Referral to RDN (patient and family)• Lifestyle modification

Healthy eating

Being active

Monitoring

Taking medication

Problem-solving

Reducing risks

Healthy coping

Figure 1

AADE7™ Self-care Behaviors

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of comorbidities such as obesity, dyslipidemia, and hypertension that may be present at diagnosis. If lifestyle modification is not successful in achieving cardioprotective levels of lipids and blood pressure, then lipid-lowering agents, i.e., statins and blood pressure medication (ideally, angiotensin-converting enzyme [ACE] inhibitors), should be used. If fasting triglyceride levels are > 400 mg/dL or > 1000 mg/dL nonfasting, optimize blood glucose and begin fibrate with goal of < 400 mg/dL fasting to reduce pancreatitis risk. Monitor liver function tests to assess for non-alcoholic fatty liver disease.

Microvascular complications should be surveilled with routine assessment of random urine albumin-to-creatinine ratio and a dilated eye examination performed at diagnosis and then annually. Addi-tionally, all children with diabetes should receive preventive vaccinations according to age specific recommendations (cdc.gov/vaccines/schedules/

hcp/imz/child-adolescent.html). Assessing the emotional and mental well-being of

the young patient for diabetes distress is important. Experts suggest doing so at diagnosis or by 7 or 8 years of age, whichever comes first.

ConclusionCare of youth with T2DM is the aim of many research studies. More data are necessary to help determine strategies that provide optimal care for children and adolescents with the disorder. Mean-while, close monitoring of overweight and obese pediatric patients’ glycemic status is essential. An early aggressive approach of lifestyle modification to try to prevent or delay T2DM should be consid-ered. Care should be taken to help the patient and family understand that an absence of symptoms with prediabetes and early T2DM does not mean the disease is less serious. Lifestyle modification can benefit the whole family with T2DM genetics.

Medication* Glycemic Values Considerations

Metformin BID A1C ≤8.5% Patient is asymptomatic.Normal renal function.

Titrate metformin up to 2000 mg/day as tolerated.

Metformin BIDBasal insulin

A1C >8.5%BG ≥250 mg/dL

Marked hyperglycemia with symptoms; without ketosis.Titrate metformin up to 2000 mg/day (as tolerated).

Start basal insulin at 0.5 units/day; titrate every 2-3 days until goals met.

Metformin BIDBasal insulin

Meeting glucose targets via SMBG Decrease basal insulin 10 to 30% every few days while maintaining SMBG targets.

Basal insulin (add bolus insulin as needed)

A1C and/or SMBG values no longer meet target.

Intolerable side effect profile using metformin.Basal insulin up to 1.5 units/kg/day, then initiate multiple daily

injections basal + premeal bolus.

*Use of medications not approved by the U.S. Food and Drug Administration for use in youth with T2DM is not recommended outside of research trials.

PATIENT CASE: AMSeven months follow-up (no-show at six months due to family emergencies)

• A1C 10.1%• Weight 106 kg; BMI 36 kg/m2• B/P 130/85• Metformin (self-discontinued, c/o diar-

rhea)• Polyuria, polydipsia, polyphagia• Glargine 0.3 units/kg/day• Lispro 1.0 unit/5g carbohydrate• Correction 1.0 unit lispro/20 mg/dL >130

mg/dL

SMBG increased to ac/hs; weekly reporting

PATIENT CASE: AMThree months later*

• A1C: 7.0%• Weight: 107 kg; BMI 37kg/m2• Lifestyle modification reinstituted• Increase glargine (0.6u/kg)• Metformin XR 1000mg BID• Discontinue lispro• Lipid profile • Referral to ophthalmologist

*Note, mother diagnosed with T2DM diabe-tes since previous visit.

Table 2

Pharmacologic Management: Pediatric Patients with T2DM

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Youth with T2DM: Expert StrategyStrategies from Pediatric Endocrinology Providers: Janet Silverstein, MD, professor, UF Pediatrics and Anastasia Albanese-O’Neill, PhD, ARNP, CDE, assistant clinical professor and director of Diabetes Education and Clinic Operations. Both are from the Division of Pediatric Endocrinology, Department of Pediatrics at the University of Florida.

A major challenge in providing care for youth with Type 2 diabetes is promoting lifestyle change, while simultaneously making sure the child feels supported and has clear goals that are achievable. Motivational interviewing has been the most effec-tive tool for incentivizing these young people, many of them adolescents. In order to fit this into the time constraints of an office visit, we recommend the following.

◆ Be very supportive and nonjudgmental. ◆ Ask about how important it is for them to lose

weight on a scale of 1-10 (1=not important, 10= very important). If they say 1-4, there is not much

you can say to cause behavior change. ◆ Talk about a few easy steps they might take to

lose weight, including portion sizes (palm and fist);  waiting 20 minutes before eating seconds (will then feel full); if eating before a screen, put portion sizes of snacks in a bowl rather than eating out of bag or box, etc.

◆ Advise adolescents to eliminate sweet drinks and replace them with water, Crystal Lite™, or other sugar-free beverages they like.

◆ Start with 30 minutes if completely inactive; physical activity can be done throughout the day, doesn’t need to be done all at once.

◆ Have them choose what two to three tasks they think they can do (they think it is brilliant if it comes from them, but just another dictum from adults if it comes from us).

◆ Give them a written sheet with their goals on it, to be signed by both the health-care provider and patient.

◆ Give them an achievable weight loss goal, no more than two to three pounds per month. PD

REFERENCESRead all of this issue’s references online at bit.ly/2DxxSMASH

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DANA FOR DIVAS: INTEGRATING TECHNOLOGY INTO A DIABETES PRACTICEThe sheer volume of devices and apps entering the diabetes market can be daunting for physicians and diabetes educators. To keep up to date with the lat-est technologies in diabetes, practitioners must sift through numerous press releases, technology and health-care blogs, feedback forums, manuals and webinars, or wait for the next annual health-care tech conference. The selection of appropriate devices and apps for each patient requires time that practitio-ners do not have, making the integration of diabetes technology into practice difficult.

“Technology is changing very fast, and it’s hard to keep up,” says Crystal Broj, chief technology and innovation officer, American Association of Diabetes Educators (AADE). AADE conducted a survey within its network of more than 14,000 diabetes educators and found that 93 % wanted to learn about new diabetes technology. However, 85 percent admitted they did not have the resources to locate the information they needed.1 “This is why we created DANA,” explains Broj.

What is DANA?Launched on August 6, 2018, Diabetes Advance Network Access (DANA) was designed to provide AADE members with a one-stop site to navigate the plethora of information, news, training, sup-plies, product reviews, use cases, and other resources related to devices/apps for diabetes and prediabe-tes.1,2 According to Broj, “DANA makes it easy for diabetes educators to quickly access various resources in one place.”

Integrating diabetes technology into practiceBy providing practitioners access to expertly curated

information on diabetes technology, DANA can promote the effective integration of devices/apps into clinical practice. Diabetes-related technol-ogy such as digital continuous glucose monitors (CGMs), insulin pumps, and digital health plat-forms help patients manage their condition and help practitioners track a patient’s symptoms, diet, lifestyle, and medication intake. Specifically, DANA facilitates a health-care provider-patient discussion, enables information searching, teaches optimal health data utilization, and sparks practitioner engagement in innovation.

Discussing device options and app reviewsIn its product section, DANA lists over 200 prod-ucts, including CGMs, blood glucose monitors, pens, infusion sets, medication delivery devices, and insulin pumps, outlining their product specifications and manufacturer details.3 Health-care providers can access the site to discuss treatment and management options with a patient. For example, “A practitio-ner can discuss CGM options by showing them in DANA during their visit,” says Broj.

In addition, diabetes apps focus on different areas of diabetes health—fitness, diet, lifestyle, dis-ease management, or symptom management—and can confuse users.3 Practitioners can use DANA’s app review section to identify the appropriate app and provide real-time patient assistance on how

TECHNOLOGY

Nicola Davies, PhDHealth psychologist and author of I Can Beat Obe-sity! Finding the Motivation, Confidence and Skills to Lose Weight and Avoid Relapse.

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to use it. “A practitioner can review the apps with patients and even share a link to the review or assist the patient in downloading an app they suggest,” says Broj.

A third-party evaluator, DHX Labs, rates the apps based on the Xcertia (a government and indus-try collaborative that advocates for rules on mobile health platforms) guidelines. These guidelines use more than 150 criteria, including usability, privacy, security, and operability.3 “Educators can know exactly how the app they recommend stands up to these guidelines,” says Broj.

Quick searches for technology informationPractitioners can use DANA whenever they need real-time guidance on making a treatment deci-sion for a patient. According to Broj, “If a health-care provider has a question, they can post it on the DANA discussion board or use the extensive search feature to find the information they need. DANA allows the practitioner to have more up-to-date information for their patients and a place to go when they have a question or are looking for additional options for their patients.”

Practitioners can also leverage the breadth of expert information and opportunities for continu-ing education that the site offers. DANA has an education section in which members can access live and on-demand webinars and courses on diabetes and technology.3 “DANA also has technology news from several outlets, including diaTribe and Diabe-tesMine. The resources section has over 100 links,

articles, and peer-reviewed resources in a variety of areas,” adds Broj.

Optimizing use of patient dataOne main benefit of using digital devices in dia-betes management is the ability to monitor the patient and gather health data. Practitioners play a critical role in ensuring the data are explained to the patient and properly analyzed to inform the patient’s treatment requirements.1 DANA was specifically created to promote the optimal use of diabetes technology and the health data it generates. “DANA offers training and education that dive deep into how to effectively use the data coming out of these devices to drive better outcomes. A practitioner can brush up on a blood glucose meter, for example, before a particular patient enters their office,” states Broj.

Accessing opportunities to shape technological innovation in diabetesDANA is a platform on which practitioners can engage with the innovative trajectory of technological devices and mobile apps in diabetes care. “Outside of the product and education areas, DANA has an innovation section that has polls and focus groups that practitioners can use to participate in shaping technology,” Broj said. Health-care providers and educators can participate in product testing and market research, which will enable them to invest time and expertise in discussions that could influ-ence decision-making processes, refine diabetes technology, and shape innovation.3

DANA for positive health outcomesWhile DANA targets AADE members, its ultimate objective is to drive better health outcomes for people living with diabetes by optimizing tech-nological use and supporting patients. “DANA is a resource to enable practitioners, working in partnership with people with diabetes, to have access to best-in-class information about diabetes technology,” says Broj. “Our goal is to empower collaborative decision-making in the care and man-agement of people with diabetes, leading to positive health outcomes.”

DANA can also boost technological adoption among patients.1 According to Broj, AADE mem-bers are more likely to recommend a technology to their patient once they have studied it. With a recent $2.6 million grant from the Leona M. and Harry B. Helmsley Charitable Trust, DANA is set to continue its operations, ensuring that members do not miss out on learning about the technological advance-ments that could improve their patients’ lives.1,4 PD

REFERENCESRead all of this issue’s references online at bit.ly/2DxxSMA

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TECHNOLOGY

IN SEARCH OF THE PERFECT CGM REPORT

Sensor Overlays Provide Insights that AGP Often MissIn busy clinical practices, time is of the essence. When patients arrive with devices ready for down-loading, we must access reports that allow quick analysis, generate the right questions, and lead to sensible conclusions.

Adoption of continuous glucose monitors (CGMs) is growing rapidly among health-care pro-viders and patients, particularly for patients who take insulin. A multitude of systems are now avail-able: Dexcom’s G5 and G6, Medtronic’s Guardian Connect and sensor-augmented pumps, Abbott’s Freestyle Libre, and Senseonics’ Eversense. Each system has its own report-generating software, and a number of “midware” programs can merge the data from multiple devices, including CGMs.

Each software program has the ability to gen-erate a variety of different reports. All have the ability to produce statistical summaries that can be useful for evaluating general glycemic control and tracking progress from one appointment to the next. For example, the average (mean) glu-cose correlates closely with A1C. The standard deviation or coefficient of variation provides some insight into overall glucose variability. In addition, the frequency of high/low alerts allows us to see how often the patient is approaching potentially dangerous excursions. However, the granddaddy of all stats is the percentage of time spent above, below, and within one’s target range. This is prob-ably the best measure of the quality of one’s glucose control, as opposed to the others that represent quantity metrics.

Beyond statistical summaries, trend graph reports offer insight into the specific nature of patients’ glucose levels throughout the course of the day and night. Most software can generate three types of trend graph reports: individual day reports, multiple-day overlays, and summary graphs, which take the form of either hourly summaries or the popular ambulatory glucose profile (AGP). Let’s take a look at some of the unique aspects of each.

Daily trend graphsIndividual day trend graphs provide a granular look at glucose values on a single-day basis (Figure 1).

When combined with pertinent information such as food intake, insulin doses, and physical activity, it is possible to observe cause-and-effect relation-ships on daily trend graphs. Basal insulin doses can be evaluated by observing glucose stability between prolonged intervals of meals and boluses. But with-out knowing the timing and nature of these types of daily events, the graphs lack context. It is difficult to observe repeated daily trends, even when the graphs are laid one above another (Figure 1). Determining the extent of post-meal glucose spikes or timing of hypoglycemic events, for example, requires a detailed review of many daily reports, which can take up valuable appointment time.

AGP: CGM data simplifiedIn search of a more user-friendly way to visual-ize CGM data, the International Diabetes Center developed the AGP report, a standardized report that

Figure 1

Daily trend graphs displayed from a Freestyle Libre download

Sat 28 Jul

Sun 29 Jul

Mon 30 Jul

Tue 31 Jul

Wed 1 Aug

Thu 2 Aug

00:00 06:00 12:00 18:00 00:00

Gary Scheiner MS, CDEOwner and clinical director of Integrated Diabetes Services, a private practice specializing in intensive therapy for children and adults.

Reviewed by Alissa Heizler-Mendoza, MA, RD, CDESenior director of advocacy and government affairs at Insulet.

Practical Diabetology • Vol. 38, No. 1 • March/April 2019 999

breaks CGM data down into five-minute intervals and displays it in a graphic format to show daily ebb and flow. The report includes a median line, a shaded area that includes the middle 50% of readings (25% above the median and 25% below) for each hour, and another shaded area that includes the middle 80% of readings (10% of readings are above the high end, and 10% of readings are below the low end). Slight variations of the AGP are provided by a variety of downloading/reporting programs, but the basic premise is about the same (Figure 2).

The essence of an AGP report is its uniformity and simplicity. The times of day when the blue shaded areas reach beyond high and low target levels raise concern since a significant amount of time (more than 25%) is spent either above or below one’s target range. The gray shaded area is more of a “gray area” because glucose is only occasionally outside of the target zone. It is necessary to evalu-ate one to two weeks of data for the AGP report to have validity, since single high or low events can produce significant percentages of out-of-range readings when evaluating only a few days at a time. In addition, the times of day when the blue range is uncharacteristically wide represent periods of extreme glucose variability. This may be due to variation in food intake, stress levels, or physical activity or a lack of compensatory insulin/medica-tion for these situations.

Unfortunately, while AGP reports look pretty and sound important, overall, they may not offer much in the way of practical information. One of the greatest limitations of the AGP report is the

relative inability to draw firm conclusions from it. Very few CGM users follow a consistent, regimented schedule in terms of meals, snacks, exercise, and sleep. For example, an early morning “dawn phe-nomenon” may not be captured in the AGP report if a patient’s sleep schedule changes from day to day. Post-meal glucose peaks may not appear for an individual whose meals start and end at different times throughout the week. Finally, establishing

Beware of making recommendations

based solely on averages. It’s the

details that matter.—Nicholas Argento, MD

Figure 2

AGP Report.

Source: www.agpreport.org/agp/agpreports#CGM_AGP

Figure 3

Sensor daily overlay report from Medtronic Carelink, 2016.

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Practical Diabetology • Vol. 38, No. 1 • March/April 20191010

cause-and-effect relationships is often not possible when looking at summaries of large sums of data.

Sensor overlays, aka “spaghetti graphs”“Spaghetti graphs”—the multi-colored sensor overlay reports from CGMs can often be intimidating at first encounter (Figure 3).

In fact, sensor overlay reports (also called modal day reports) provide everything AGP reports yield and much more. These reports provide meaningful insights that translate into relevant solutions. As with AGP reports, sensor overlay reports reveal times of day when glucose levels are often above or below the target range. In fact, they do a better job because they give the reviewer the opportunity to visually disregard rare outliers that can influence sta-tistical summaries. They also show the glucose trend in a fasting state (for evaluating basal insulin). By being able to follow the tracing for individual days, the reviewer can also:

◆ evaluate post-meal peaks regardless of the exact time the meal was eaten;

◆ determine whether correction doses of insulin are routinely bringing the glucose level down too much, too little, or just the right amount;

◆ uncover patterns that precede or follow periods of hypoglycemia;

◆ quantify the precise duration of bolus action; ◆ estimate the effectiveness of mealtime insulin

doses; and ◆ identify important but less common events, such

as severe prolonged nocturnal hypoglycemia.A few subsets of the sensor overlay report can

provide even greater insight. The “Sensor Overlay By Meal” (now called “Meal Bolus Wizard” in the latest version of Carelink Personal and Professional) lines up the time on the x-axis based on when meal boluses are delivered. The overlaid trend graphs extend one hour prior to the meal bolus and three hours after the meal bolus so that the effectiveness of the dose can be seen rather clearly, along with the extent of the post-meal glucose excursion (Figure 4).

Another subset report, available when reviewing data in programs such as Glooko and Dexcom Clar-

ity, is a daily overlay sorted by day(s) of the week. This report allows for a quick and easy evaluation of glucose patterns on weekends versus weekdays, exercise versus non-exercise days, work versus off days, or any other semi-regular event that takes place in a patient’s life. You may notice that glucose levels are uncharacteristically elevated on many Wednesday afternoons, which can prompt a discussion with the patient to determine the likely cause.

“It’s rarely a good idea to make changes based on summary reports like AGP alone,” says Nicholas Argento, MD, an endocrinologist in central Mary-land specializing in Type 1 diabetes. “That would be like assessing the patient based on just A1C or a single fasting blood glucose. There is a great deal to be learned from the details.”

To further reinforce the value of the sensor overlay (spaghetti) graph compared to the AGP, take a look at the AGP report in Figure 5.

It appears that the glucose levels are rising in the middle of the night and are generally stable through most of the day. The only conclusion one might draw is that the basal insulin dose is too low during the early part of the night, or perhaps the patient is not properly covering a late-night snack.

Figure 4

Meal bolus wizard from Medtronic Carelink Personal and Professional

Practical Diabetology • Vol. 38, No. 1 • March/April 2019 1111

Now take a look at the report for the same patient, covering the same time period, in Figure 6.

This report also shows a fairly consistent pattern of rising glucose in the middle of the night. Notice the frequency of lows in the evening? The rises in the early part of the night can be traced back to these hypoglycemic events; thus, one might conclude that the patient is “rebounding” from the lows. Interest-ingly, the one night not resulting in an overnight rise (Thursday) was preceded by an evening without a low. The elimination of the lows will likely prevent the nighttime highs. Therefore, it is possible that the dinner insulin dose is too aggressive. Or, based on the very rapid decline in the 8-9pm range, the lows may be related to evening exercise, which can be explored with the patient. Considerable post-meal spikes occur on some but not all occasions, and a discussion of proper insulin timing based on the

nature (glycemic index) of the meal may be help-ful. The one day with a significant morning spike (Friday) was preceded by a low blood glucose at mid-morning. Perhaps the patient is over-treating hypoglycemia. Also noteworthy is that the glucose levels on Sunday were much higher and more erratic than the rest of the week. This is yet another topic for discussion and problem-solving.

Clearly, from the standpoint of yielding useful clinical insight, the spaghetti graph wins. It still allows for a quick view of the overall state of glucose levels and also helps uncover potential cause-and-effect relationships. At a minimum, it lays the frame-work for productive conversations with the patient.

According to Argento, “The overlay allows one to drill down and figure out where the problems really are. It allows you to ask the right questions and come up with the right solutions.” PD

Figure 6

CGM Data Overlay report from Dexcom Clarity

Figure 5

Seven-day AGP report from Dexcom Clarity

Practical Diabetology • Vol. 38, No. 1 • March/April 20191212

COMMENTARYUSING TANDEM’S BASAL-IQ TECHNOLOGY WITH YOUR PATIENTS The product: The latest from Tandem Diabe-tes Care®, Basal-IQ™ Technology is a predictive low-glucose suspend feature on the t:slim X2™ Insulin Pump that integrates with the Dexcom G6® Continuous Glucose Monitoring (CGM) System. The Basal-IQ feature helps reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to drop below 80 mg/dL or anytime they drop below 70mg/dL. The feature suspends insulin delivery for as few as five minutes and up to 120 minutes. The graph shows how the feature predicts, suspends, and resumes insulin based on CGM data. Insulin resumes in as few as five minutes, as soon as glucose values rise by 1 mg/dL. A pivotal trial, Predictive Low-Glucose Suspend for Reduction of Low Glucose (PROLOG), found that Basal-IQ Technology not only prevented the frequency and duration hypoglycemia, but also reduced rebound hyperglycemia.1

What problems does Basal-IQ Technology help solve?Hypoglycemia is at the top of the list of frustrations for people with diabetes. Whether mild or severe, all forms of hypoglycemia take time and quality away from everyday life. For example, among people with non-severe hypoglycemic events (NSHE) (able to self-treat), 18.3 percent experienced decrease in work productivity.2 Additionally, many patients suffer from hypoglycemia unawareness, which is the inability to feel the signs and symptoms of low

blood glucose in a timely fashion. Hypoglycemia unawareness is dangerous and can be scary because without the help of technology, the patient may not be able to treat hypoglycemia before it becomes an emergency.

Basal-IQ Technology is not a cure-all for hypo-glycemia, but it can help patients avoid severe lows and allow them to spend less time worrying about micromanaging hypoglycemia throughout the day and night. The burden of managing a chronic disease has known impacts on mental health. Depression is twice as likely to occur in persons with diabetes.3 For some, simply the fear itself of having a low-glucose event may be enough to prevent them from taking part in activities they enjoy.2

How to learn about the product?Because automated insulin delivery (AID) sys-tems are new, it helps to have a simple acronym to understand how they work. The CARE model is a systematic approach to evaluate AID systems using four elements: calculate, adjust, revert, and educate. The following is an analysis of the t:slim X2 Pump with Basal-IQ Technology using the CARE model.4

◆ Calculate: The Basal-IQ Technology helps reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if they are expected to drop below 80 mg/dL or any-time they drop below 70mg/dL.

◆ Adjust: Basal-IQ Technology suspends and resumes insulin. Users can administer bolus

1 32

Predictsglucose 30

minutes ahead

Suspendsinsulin to help avoid the low

Resumesinsulin once

glucose rises

Molly McElwee-Malloy, RN, CDEClinical Services ManagerTandem Diabetes Care

Practical Diabetology • Vol. 38, No. 1 • March/April 2019 1313

REFERENCESRead all of this issue’s references online at bit.ly/2DxxSMA

doses, stop all insulin delivery at any time, and manually resume delivery at any time.

◆ Revert: When the Basal-IQ feature is turned on, it will only stop working if the system has not received CGM data for more than 10 min-utes (or if more than two consecutive CGM readings are missed). Basal-IQ Technology will not be able to predict glucose levels and suspend insulin delivery if your CGM is not working properly or is unable to communicate with your pump.

◆ Educate: For more information, go to www.tandemdiabetes.com/providers or talk to your local Tandem representative.

What could this product mean for your practice?When managing a patient using Basal-IQ Technol-ogy, looking at the suspension data on the Therapy Timeline is important. Look for suspensions that occur over long stretches of time (over 45 minutes) during which insulin is suspended on some regular basis. This is when Basal-IQ Technology suspensions can help identify patterns that could dictate lifestyle or therapy adjustments. For example, if you see someone has experienced an extended suspension of insulin

right after dinner three times in the last two weeks, you may need to ask some important questions such as: “Do you remember what kind of meal you ate last Tuesday and Wednesday? Should the bolus for that meal change due to high fat or high protein items?”

A wider pattern of suspensions after meals might suggest that other settings, like the insulin-to-carb ratio, may be more aggressive than necessary. You have to determine the cause of these events, but looking at patterns of longer suspensions on the therapy timeline is a great place to start.

When someone first starts using Basal-IQ Tech-nology, you can provide that person with some sim-ple tips to help ensure the experience is optimal. For example, you may want to discuss the importance of connectivity between the t:slim X2 Pump and the Dexcom G6 CGM System with patients, because the Basal-IQ Technology will not be able to predict glucose levels and suspend insulin delivery if the patient’s CGM is not working properly or is unable to communicate with the pump. For this commu-nication to be clear, the patient needs to know two things. First, the signal between the two devices travels directly through the glass screen of the pump. Since wireless signals do not travel well through the body, the screen should be facing out and on the same side of the body as the sensor. Second, when a patient begins using Basal-IQ Technology, he or she should set an out-of-range alert for the sensor, which lets the patient know when the pump and CGM are not communicating. A lapse in data of 10 minutes will prevent the Basal-IQ feature from suspending insulin based on predicted values until connection is re-established and enough data are collected to start predicting future glucose values again. Setting the alert for 20 to 30 minutes is helpful to warn the patient to troubleshoot any connectivity issues. In addition to the CGM signal, remind patients that Basal-IQ Technology is not a substitute for active diabetes management and does not prevent hypogly-cemia in all scenarios. Patients should pay attention to their symptoms and blood glucose levels and treat according to your recommendations.

Finally, you need to remember how easy Basal-IQ Technology is to use when recommending it to patients. In the PROLOG trial, 91 percent of patients stated that they felt the device was intuitive and easy to use.1 Additionally, 95 percent of patients didn’t feel like they needed help from a technical person to use the system.1 Ease of use for medical technology is so important. After all, adherence to therapy is directly tied to the patient’s experience using the device.5 When you consider that 70 percent of medical device accidents are attributable to user error,6 then ease of use becomes paramount. For more information about Basal-IQ Technology, please visit the Tandem Diabetes Care provider website at tandemdiabetes.com/providers. PD

How does system CALCULATE/CHANGE insulin delivery?

How does user ADJUST insulin doses - immedi-ately and long term?

When does user REVERT to Pump mode

Where to find EDUCATION/EXPERT help?

CARE Model

Source: Tandem Diabetes Care

Practical Diabetology • Vol. 38, No. 1 • March/April 201914

Read past editions of Journal Watch at

bit.ly/2ugYjV0

Study title: Pumps or multiple daily injections in pregnancy involving type 1 diabetes: a prespecified analysis of the CONCEPTT randomized trial

Authors: Denice S. Feig, et al on behalf of the CON-CEPTT Collaborative Group

Study title acronym: CONCEPTT Trial

ClinicalTrials.gov identifier: NCT01788527

Sponsor: Juvenile Diabetes Research Foundation (JDRF) and JDRF Canadian Clinical Trial Network

Study design: A multicenter, open-label, random-ized trial including 325 women with Type 1 diabe-tes (T1D) from 31 countries in Europe and North America who were planning pregnancy (n=110) or in early pregnancy (n=215). The original objective was to compare the efficacy of continuous glucose monitoring (CGM) versus self-monitoring of blood glucose (SMBG) on glycemic control and neonatal outcomes during a singleton pregnancy. Original study results published in 2016 demonstrated the superiority of CGM technology during pregnancy to improve glycemic control and decrease infant com-plications. The current publication reports on a pre-specified secondary analysis of the CONCEPTT trial (n=248), encompassing 248 participants, designed to compare maternal, obstetrical, and neonatal health outcomes between participants using insulin pumps (n=125) or multiple daily injections (MDI; n=123) during their pregnancy. Of this participant subset, an equal number in each group (n=62) was randomized to CGM. It is important to note, however, that the pre-pregnancy utilization of pump or MDI therapy by each participant dictated her group assignment and not an independent randomization process. Primary outcome: Change in HbA1c from baseline to 34 weeks gestation

Other outcomes: Secondary outcomes, pertinent to glycemic control, quality of life (QOL), and obstetrical/neonatal complications were also evalu-ated, including glucose control (CGM-determined glucose time-in-range, episodes of hypoglycemia, and glycemic variability); quality of life (4 (QOL) questionnaires, e.g., hypoglycemia fear, diabetes distress) completed at baseline and at 34 weeks gesta-tion); and obstetrical/neonatal outcomes (gestational

hypertension with/without preeclampsia, caesarean section delivery, gestational weight gain, pregnancy loss, birth injury, birth weight, neonatal hypogly-cemia, hyperbilirubinemia, respiratory distress, or neonatal intensive care unit (NICU) hospitalization).

Results: Despite similar baseline demographic char-acteristics (maternal age, BMI, duration of T1D, total daily insulin dose, presence of microvascular compli-cations) and similar baseline levels of glycemic control (HbA1c, percentage of time in target BG range), the MDI users actually experienced a greater improve-ment in HbA1c throughout pregnancy (-0.55 ± 0.59 (mean ± SD) versus -0.32 ± 0.65%, p=0.01) and were more likely to reach the target HbA1c compared with pump users. In contrast, pump users spent slightly less time below BG target (p=0.03) and reported less hypoglycemia fear, but also experienced an increase in gestational hypertension along with more NICU admissions for their babies, predominantly for the treatment of neonatal hypoglycemia. Reasons behind the unexpected, yet relatively better, maternal/neo-natal outcomes for MDI users were not clear-cut. Pump users were identified as being more likely to take preconception vitamins and less likely to smoke cigarettes at conception; nevertheless, statistical adjustment for such baseline confounders did not change the overall study conclusions.

Summary: This publication reports on a planned secondary analysis comparing pump users versus MDI users enrolled in the CONCEPTT trial. In women with T1D, MDI therapy during pregnancy was associated with equal or better outcomes com-pared with insulin pump therapy. The findings from this secondary analysis were counterintuitive and perhaps somewhat disheartening for proponents of insulin pump technology. The authors speculated that the technical complexities of matching pump therapy with metabolic fluctuations during pregnancy or the pharmacokinetic differences in insulin availability during pregnancy might have contributed to their findings. If so, it is possible that newer technologies, including hybrid closed-loop insulin pump technolo-gies, could better mitigate these difficulties in the future. The authors concluded that “more research is needed to better understand which women benefit from insulin pumps and how clinical teams can imple-ment new technologies more effectively to optimize glycemic control during pregnancy involving T1D. PD

JOURNAL WATCH

This column highlights clinical trial data and landmark trials. Information for obtaining trial data and the references to the published articles are provided to facilitate discussion with your patients/colleagues. The trial is identified by the acronym and the National Clinical Trials Identifier. Primary outcome results are summarized.

Kathryn Thrailkill, MDProfessor of Pediatrics, Division of Pediatric EndocrinologyBarnstable Brown Endowed Chair in Pediatric Diabetes ResearchBarnstable Brown Diabetes CenterUniversity of Kentucky, Lexington, KY

Practical Diabetology • Vol. 38, No. 1 • March/April 2019 15

EDUCATOR’S CORNER

ENTERPRISING DIABETES EDUCATORS EMBRACE DIGITAL HEALTHConsumers turn to technology in their everyday lives to communicate, perform daily tasks, and find information. Likewise, they are increasingly using technology to log and share lifestyle data, track their health status, find health information, and become more active participants in their own care. Digital health, the convergence of health care and technol-ogy, has reached a tipping point and is leading to clinical care and practice remodeling.1 This article explores the rapidly expanding role of digital health in diabetes care, the evidence advocating its use, and the leadership opportunity for diabetes educators.

Digital health in diabetes Chronic conditions such as diabetes that require ongoing self-management, regular follow-up, and therapy progression can benefit from the integration of technology-based tools. The anytime-anywhere

nature of digital technology supports the delivery of automated, individualized, contextualized coaching by enabling patients to share data and connect with their diabetes care team between appointments.2

As value-based models of care and payment are becoming established, people with diabetes are increasingly demanding diabetes care and education services outside often underutilized hospital-based diabetes self-management education and support (DSMES) services.3 Health plan care coordinators, health system population health managers, patient-centered medical homes, and employer-based health coaching programs are expected to deliver diabetes care and education. The growing complexity of dia-betes medication regimens and the extensive ongoing self-management support that people with diabetes require have led to a growing interest in digital health in these evolving care models to support health-care

teams in effectively managing their diabetes population.

The American Association of Diabetes Educators (AADE) defines the diabetes ehealth ecosystem as the use of infor-mation and communication technologies for health (Figure 1). The ecosystem goes beyond diabetes devices to include personal health devices such as physical activity and sleep trackers, cloud-based monitor-ing systems, data management platforms, telehealth services, digital education, mobile apps, digital therapeutics, and social media platforms.

But is digital health effective? It depends. While technology is poised to become a major part of the solution in transforming diabetes care, it is currently a rapidly expanding and con-fusing space. Many diabetes technology solutions offer the opportunity to track and visual-ize data related to daily diabetes care, including blood glucose, blood pressure, weight, food, physical activity, and medica-

Janice McLEOD, MA, RDN, LCN, CDEDirector of clinical innova-tion for WellDoc, maker of the BlueStar digital thera-peutic for type 2 diabetes.

Figure 1

Diabetes eHealth Ecosystem Graphic American Association of Diabetes Educators (AADE) 2016 Technology Workgroup. Based on Architecture for Integrated Mobility Framework (AIM). Reprinted by per-mission of the AADE

Practical Diabetology • Vol. 38, No. 1 • March/April 201916

tions, but most offer minimal data analysis, interpre-tation, or guidance to patients. They are categorized by the FDA as general health and wellness apps not requiring regulation.4

In contrast, a new category of therapy is referred to as digital therapeutics. A digital therapeutic must meet the following criteria5:

1. evidence- and theory-based data analysis and feedback is tailored to individual clinical needs, goals, and lifestyle;

2. connects the individual with his or her health-care team;

3. demonstrates safety and efficacy in pub-lished, peer-reviewed randomized clinical trials;

4. ensures safety and security of patient-gen-erated health data;

5. obtained FDA clearance when used as a medical device and developed in accordance with appropriate quality standards; and

6. designed to be user-friendly and engaging.

According to a 2017 systematic review of 25 stud-ies that evaluated technology-enabled DSMES, improvements in A1C ranged from 0.1 to 0.8 percent in 18 of the 25 studies.6 Four key elements were identified that were incorporated into the most effective interventions: two-way communication in a continuous feedback loop, analyses of patient-generated health data, tailored education, and indi-vidualized feedback. The authors described this

as a technology-enabled self-management (TES) feedback loop (Figure 2), which connects people with their health-care providers.

Access to and review of patient-generated health data (PGHD) can lead to more timely changes to care by providing insights for shared decision-making and proactive patient-team communication and engagement. To be of value, digital therapeutics and the resulting patient-generated health data must be integrated into clinical practice. Due to the growing evidence that digital tools improve A1C and other diabetes-related outcomes, both the 2017 National Standards for DSMES7 and the 2018 American Diabetes Association (ADA) Standards of Medical Care8 encourage inclusion of technology-enabled solutions to deliver diabetes care and education.

Transforming the role of diabetes educators An enterprising diabetes educator can utilize evidence-based digital health to increase access, reach, and effectiveness of diabetes education and care services, ultimately positioning the educa-tor as the expert consultant in leading health-care transformation in evolving practice models. Why educators? Educators are recognized as the subject matter experts for diabetes care and are skilled in the use of PGHD from their experience in using blood glucose and continuous glucose monitoring data. The diabetes educator can mentor and lead other members of the health-care team in the use of the ever-expanding PGHD with the goal of connecting individuals with their care teams through a complete feedback loop to optimize diabetes self-management and treatment. Educators are trained and oriented to provide person-centered care, including empowering individuals in building diabetes self-management and problem-solving skills.9

Diabetes educators are preparing to navigate and lead within the continuously evolving digital health and payment landscape. Training will be needed to integrate evidence-based technology tools into practice, including how to use the resulting patient-generated health data to optimize individual care. Learning how to use aggregated population-level data to assess the overall health status of a population and support quality improvement and population health initiatives is key. Technology-enabled care facilitates the pivot to data-driven versus time-bound episodic encounters. New skills in provid-ing remote (virtual) care and how best to leverage new and proposed remote monitoring codes in their practice situation are necessary.10 AADE launched the Diabetes Advanced Network Access (DANA), a hub for diabetes educators, other health-care provid-ers, and industry to learn about the latest devices, medications, mobile apps, and technology focused research in 2017.

Also in 2017, a Digital Health Learning Net-

Figure 2

Technology-Enabled Self-management (TES) Feedback Loop Adapted from: Greenwood D, Gee P, Fatkin K, et al. A systematic review of reviews evaluating technology-enabled diabetes self-management education and support. J Diabetes Sci Technol 2017;11(5): 1015-1027.

REFERENCESRead all of this issue’s references online at bit.ly/2DxxSMA

work (DDHLN) was established collaboratively by AADE and the digital health company Welldoc. The ongoing intent of the network is to provide oppor-tunities for diabetes educators to develop and share best practices for integrating a digital therapeutic in various practice settings. Educators are exploring how the use of technology enables them to take on new roles and how to position themselves as leaders in population health management. Educators mentor the care team in the timely use of patient-generated health data to identify and resolve self-care barriers and to collaboratively optimize care plans in a timely manner. The network is open to new participants and plans to expand to include other members of the care team. If interested, the reader can email [email protected].

Virtual care payment As the use of technology in health care grows, both fee-for-service and value-based models of payment will increasingly cover virtually delivered diabetes health services. Medicare incentivizes remote patient care within its Merit-based Incentive Payment Sys-tem (MIPS), including as one of the recognized MIPS improvement activities the use of digital tools to monitor patient-generated health data with clini-cally endorsed tools that include an active feedback

loop providing actionable information to patients and their care teams.11

Starting in 2018, Medicare “unbundled” an exist-ing Part B CPT code, 99091, now paying separately for remote patient monitoring by qualified providers, including physicians, nurse practitioners, physician assistants, and clinical nurse specialists. Providers can be paid approximately $58 for a cumulative time of 30 minutes per month to review biometric data the patient and/or caregiver digitally transmits and to communicate the findings and care plan recommen-dations to the patient and/or caregiver. Additional new remote monitoring codes are proposed for 2019, reflecting the growing potential of using connected health tools to better support health-care teams in population health services, including using tech-nology to connect with their patients at home and gather data for care management and coordination.12

Technology is rapidly transforming health care. Opportunities are here for health-care teams to lever-age these tools to improve diabetes outcomes for their diabetes population. Educators, with their extensive experience in the practical use of patient-generated health data, person-centered diabetes care, and self-management training, are uniquely positioned as valued team members to integrate evidence-based technology tools into clinical practice. PD

Figure 3

Examples of technology-enabled solutions for diabetes

BlueStar (Welldoc)

A FDA-cleared, clinically validated digital therapeutic for Type 2 diabetes, BlueStar pro-vides automated, real-time coaching tailored to the user’s treatment and self-management plan, his or her personal routine, and the types and timing of data he or she is sharing either manually or through synced wearables, apps, meters, or trackers. This allows 24/7 support to be provided when individuals are navigating the complexities of diabetes on their own. Individuals can share their data with their care teams on a regular schedule or as needed to support collaborative care. Published randomized clinical trials have demonstrated the efficacy of BlueStar in improving diabetes outcomes. AADE’s DSMES curriculum is embedded digitally in BlueStar.

Livongo This AADE-accredited digital health program combines remote blood glucose monitoring through a connected blood glucose meter with virtual certified diabetes educators who provide real-time coaching when patients experience hypo- or hyperglycemia. These virtual interactions to resolve blood glucose excursions often include additional diabetes education relevant to the individual. Educators are available on-demand to users by text or email.

OneDrop ADA-recognized, this mobile app provides in-app coaching by a certified diabetes educator on blood glucose management for individuals with diabetes. The app facilitates track-ing of blood glucose and diabetes self-management data and includes a digital diabetes education program.

OnDuo A virtual diabetes clinic that provides either a connected blood glucose meter or a continu-ous glucose monitor to facilitate remote monitoring. It offers an app for data tracking and visualization and virtual diabetes coaching by certified diabetes educators. Individuals can connect with their diabetes coach through text or email. OnDuo has licensed AADE’s DSMES curriculum.

To learn more, visit www.tandemdiabetes.com/providers.

Basal-IQ technology helps reduce the

frequency and duration of low-glucose

events by predicting glucose levels 30

minutes ahead and suspending insulin

if they are expected to drop below 80

mg/dL. With Dexcom G6® Continuous

Glucose Monitoring (CGM) integration,

zero fingersticks are required for cali-

brations or mealtime dosing.*

400

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3HRS

mg/dL88

3:24 PMNovember 14100% 235 u

1 2 3

INSULIN ON BOARD 1.1 u | 1:09 hrs

0050 3

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33

Predicts and helps prevent lows with zero fingersticks*

Now with Basal-IQ™ Technology

1. Forlenza GP, Li Z, Buckingham BA, Pinsker JE, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: Results of the PROLOG trial. Diabetes Care. 2018;41(10):2155-2161. doi:10.2337/dc18-0771.

Important Safety Information: RX ONLY. The t:slim X2 insulin pump with Basal-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Basal-IQ technology, and a compatible CGM. CGM sold separately. The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim X2 insulin pump can be used solely for continuous insulin delivery and as part of the System. When the System is used with a compatible iCGM, Basal-IQ technology can be used to suspend insulin delivery based on CGM sensor readings. Interpretation of the System results should be based on the trends and patterns seen with several sequential readings over time. CGM also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Compatible iCGM systems are intended for single patient use and require a prescription. The System is indicated for use in individuals 6 years of age and greater. The System is intended for single patient use and requires a prescription. The System is indicated for use with NovoLog or Humalog U-100 insulin. The System is not approved for use in pregnant women, persons on dialysis, or critically ill patients. For detailed indications for use and safety information, call Tandem toll-free at (877) 801-6901 or visit www.tandemdiabetes.com/safetyinfo. © 2019 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care is a registered trademark and t:simulator, t:slim X2, and Basal-IQ are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. Covered by one or more U.S. and international issued and pending patents. ML-1003577_B

Less time lowrelative reduction in sensor time below 70 mg/dL, with no evidence of rebound

hyperglycemia, compared to a standard CGM-integrated pump without the Basal-IQ feature.1

31%

Simple to useof study participants said the Basal-IQ feature on the t:slim X2 insulin pump

was simple and easy to use.191%

Basal-IQ technology is not a substitute for active self-management of your diabetes. Visit www.tandemdiabetes.com/tslimx2#use for more information. *If glucose alerts and CGM readings do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.

(877) 801-6901www.tandemdiabetes.com A demo as simple as our pumps!

DOWNLOAD IT TODAY:

Text DEMO to TANDEM (826336)

CLINICAL STUDY RESULTS:

Practical Diabetology • Vol. 38, No. 1 • March/April 2019

REFERENCES

DANA FOR DIVAS: INTEGRATING TECHNOLOGY INTO A DIABETES PRACTICE1. American Association of Diabetes Educators. AADE awarded more than $2.6 million by The Helmsley Charitable Trust in support of DANA, a first-of-its-kind technology curation hub for health-care professionals. Diabetes Educator. August 2018. https://www.diabetese-ducator.org/news-and-publications/press-releases/press-releases/2018/08/23/aade-awarded-more-than-%242.6-mil-lion-by-the-helmsley-charitable-trust-in-support-of-dana-a-first-of-its-kind-tech-nology-curation-hub-for-healthcare-pro-fessionals. AccessedSeptember 9, 2018.

2. American Association of Diabetes Edu-cators. DANA. 2018. https://www.danat-ech.org. Accessed September 10, 2018.

3. American Association of Diabetes Edu-cators. AADE’s DANA: one-stop health-care technology resource for diabetes educators. Diabetes Educator. August 2018. https://www.diabeteseducator.org/news-and-publications/press-releases/press-releases/2018/08/06/aade-s-dana-one-stop-healthcare-technology-re-source-for-diabetes-educators. Accessed September 8, 2018.

4. McElwee-Malloy, M. DANA: on-demand technology expert at your fingertips. Diabetes Educator. August 2018. https://www.diabeteseducator.org/news/aade-blog/aade-blog-details/molly-mcelwee-malloy/2018/08/10/dana-the-on-demand-technology-expert-at-your-fingertips. Accessed September 8, 2018.

To learn more, visit www.tandemdiabetes.com/providers.

Basal-IQ technology helps reduce the

frequency and duration of low-glucose

events by predicting glucose levels 30

minutes ahead and suspending insulin

if they are expected to drop below 80

mg/dL. With Dexcom G6® Continuous

Glucose Monitoring (CGM) integration,

zero fingersticks are required for cali-

brations or mealtime dosing.*

400

50100150200250300350

3HRS

mg/dL88

3:24 PMNovember 14100% 235 u

1 2 3

INSULIN ON BOARD 1.1 u | 1:09 hrs

0050 3

HRS

33

Predicts and helps prevent lows with zero fingersticks*

Now with Basal-IQ™ Technology

1. Forlenza GP, Li Z, Buckingham BA, Pinsker JE, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: Results of the PROLOG trial. Diabetes Care. 2018;41(10):2155-2161. doi:10.2337/dc18-0771.

Important Safety Information: RX ONLY. The t:slim X2 insulin pump with Basal-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Basal-IQ technology, and a compatible CGM. CGM sold separately. The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim X2 insulin pump can be used solely for continuous insulin delivery and as part of the System. When the System is used with a compatible iCGM, Basal-IQ technology can be used to suspend insulin delivery based on CGM sensor readings. Interpretation of the System results should be based on the trends and patterns seen with several sequential readings over time. CGM also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Compatible iCGM systems are intended for single patient use and require a prescription. The System is indicated for use in individuals 6 years of age and greater. The System is intended for single patient use and requires a prescription. The System is indicated for use with NovoLog or Humalog U-100 insulin. The System is not approved for use in pregnant women, persons on dialysis, or critically ill patients. For detailed indications for use and safety information, call Tandem toll-free at (877) 801-6901 or visit www.tandemdiabetes.com/safetyinfo. © 2019 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care is a registered trademark and t:simulator, t:slim X2, and Basal-IQ are trademarks of Tandem Diabetes Care, Inc. Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. Covered by one or more U.S. and international issued and pending patents. ML-1003577_B

Less time lowrelative reduction in sensor time below 70 mg/dL, with no evidence of rebound

hyperglycemia, compared to a standard CGM-integrated pump without the Basal-IQ feature.1

31%

Simple to useof study participants said the Basal-IQ feature on the t:slim X2 insulin pump

was simple and easy to use.191%

Basal-IQ technology is not a substitute for active self-management of your diabetes. Visit www.tandemdiabetes.com/tslimx2#use for more information. *If glucose alerts and CGM readings do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.

(877) 801-6901www.tandemdiabetes.com A demo as simple as our pumps!

DOWNLOAD IT TODAY:

Text DEMO to TANDEM (826336)

CLINICAL STUDY RESULTS:

SCREENING, DIAGNOSIS, AND MANAGEMENT OF TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS1. Lawrence JM, Imperatore G, Pettitt DJ, et al. Incidence of diabetes in United States youth by diabetes type, race/eth-nicity, and age, 2008-2009 (Abstract). Diabetes. 2014;63(suppl 1):A407.

2. Pettitt DJ, Talton J, Dabelea D, et al. Prevalence of diabetes in U.S. youth in 2009: the SEARCH for diabetes in youth study. Diabetes Care. 2014;37:402-408.

3. Imperatore G, Boyle JP, Thompson TJ, et al. Projections of type 1 and type 2 diabetes burden in the U.S. popula-tion aged <20 years through 2050: dy-namic modeling of incidence, mortality, and population growth. Diabetes Care. 2012;35:2515-2520.

4. Nadeau KJ, Anderson BJ, Berg EG, et al. Youth onset type 2 diabetes consensus report: Current status, challenges, and priorities. Diabetes Care. 2016;39:1635-1642.

5. Copeland KC, Zeitler P, Geffner M, et

al. TODAY Study Group. Characteristics of adolescents and youth with recent-onset type 2 diabetes: the TODAY cohort at baseline. Journal Clin EndocrinolMetab. 2011;96:159-167.

6. American Diabetes Association. Chil-dren and adolescents. Standards of medical care in diabetes—2019. Diabe-tes Care. 2019;42(suppl 1): S148-S164. https://professional.diabetes.org/content-page/standards-medical-care-diabetes . Accessed December 19, 2018.

7. Perry KL, Troiano RP, Ballard RM, et al. The physical activity guidelines for Ameri-cans. JAMA 2018;320(19):2020-2028. doi:10.1001/jama.2018.14854

8. Copeland KC, Silverstein J, Moore KR, et al. Clinical practice guideline: manage-ment of newly diagnosed type 2 melli-tus (T2DM) in children and adolescents. American Academy of Pediatrics. 2013. http://pediatrics.aappublications.org/con-tent/pediatrics/131/2/364.full.pdf. Ac-

cessed October 17, 2018.

9. Morales AE. Pediatric type 2 diabetes mellitus treatment and management. Med-scape. 2017. https://reference.medscape.com/article/925700-treatment#d9. Ac-cessed October 17, 2018.

10. American Association of Diabetes Educators. AADE7™ self-care behaviors position statement. 2011. https://www.diabeteseducator.org/docs/default-source/practice/practice-resources/position-statements/aade7-self-care-be-haviors-position-statement.pdf?sfvrsn=6. Accessed October 17, 2018.

11. Young-Hyman D, de Groot M, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Psychosocial care for people with diabe-tes: a position statement of the American Diabetes Association. Diabetes Care. 2016;39:2126-2140

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Practical Diabetology • Vol. 38, No. 1 • March/April 2019

REFERENCES

EDUCATOR’S CORNER – ENTERPRISING DIABETES EDUCATORS EMBRACE DIGITAL HEALTH1. Iyengar V, Wolf A, Brown A, Close K. Challenges in diabetes care: can digital health help address them? Clinical Dia-betes. 2016;34(3):133-141. doi: 10.2337/diaclin.34.3.133.

2. IQVIA. Institute report. The growing value of digital health evidence and im-pact on human health and the healthcare system. November 7, 2017. https://www.iqvia.com/institute/reports/the-growing-value-of-digital-health. Accessed Octo-ber 20, 2018.

3. Warshaw, H. Evidence-based diabetes management. Is it time to remodel diabe-tes self-management education and sup-port? AJMC. September 2018.

4. U.S. Food and Drug Administra-tion. Medical devices. Guidances with digital health content. (https://www.fda.gov/MedicalDevices/DigitalHealth/ucm562577.htm. Accessed October 20, 2018.

5. Joyce, MD, Leclerc K, Westhues J. Digital therapeutics: preparing for takeoff. McK-insey & Company. February 2018. https://www.mckinsey.com/industries/pharmaceu-ticals-and-medical-products/our-insights/digital-therapeutics-preparing-for-takeoff. Accessed October 20, 2018.

6. Greenwood D, Gee P, Fatkin K, Peeples M. A systematic review of reviews evalu-ating technology-enabled diabetes self-management education and support. J Diabetes Sci Technol. 2017;11(5):1015-1027.

7. Beck J, Greenwood DA, Blanton L, et al. 2017 national standards for diabetes self-management education and sup-port. Diabetes Educ. 2017;43(5):449-464. 1):S38-S50.

8. American Diabetes Association. Life-style management. Standards of medical care in diabetes--2018. Diabetes Care. 2018;41(Suppl 1):S33-S43.

9. MacLeod J, Peeples M. Are you ready to be an eeducator? AADE in Practice. 2017;5(5):30-35.

10. 10. Nochomovitz, M, Sharma, R. Is it time for a new medical specialty? the medical virtualist. JAMA. November 27, 2017. doi:10.1001/jama.2017.17094.

11. Improvement Activities Requirements PY 2018. Quality Payment Program. 2018. https://qpp.cms.gov/mips/improvement-activities. Accessed October 20, 2018.

12. AMA releases 2019 CPT code set. American Medical Association. 2018. https://www.ama-assn.org/ama-releases-2019-cpt-code-set. Accessed October 20, 2018.

JOURNAL WATCH1. Feig DS, Asztalos E, Corcoy R, De Leiva A, Donovan L, Hod M, et al. CON-CEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Preg-nancy Trial: a multi-center, multi-national, randomized controlled trial-study pro-tocol. BMC Pregnancy and Childbirth. 2016;16(1):167.

2. Feig DS, Corcoy R, Donovan LE, Murphy

KE, Barrett JFR, Sanchez JJ, et al. Pumps or multiple daily injections in pregnancy in-volving type 1 diabetes: a prespecified analysis of the CONCEPTT randomized trial. Diabetes Care. 2018;41(12):2471-2479.

3. Feig DS, Donovan LE, Corcoy R, Mur-phy KE, Amiel SA, Hunt KF, et al. Con-tinuous glucose monitoring in pregnant

women with type 1 diabetes (CON-CEPTT): a multicentre international randomised controlled trial. Lancet. 2017;390(10110):2347-2359.

COMMENTARY – USING TANDEM’S BASAL-IQ TECHNOLOGY WITH YOUR PATIENTS1. Forlenza GP, Li Z, Buckingham BA, Pinsker JE, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized cross-over study: results of the PROLOG trial. Diabetes Care. 2018;41(10):2155-2161. doi:10.2337/dc18-0771.

2. Brod M, et al. The impact of non-severe hypoglycemic events on work productivity and diabetes manage-ment. Value Health. 2011;14(5):665-671.

doi:10.1016/j.jval.2011.02.001.

3. Moulton CD, et al. The link between depression and diabetes: the search for shared mechanisms. Lanct Diabetes Endo-crinol. 2015;3(6):461-471. doi:10.1016/S2213-8587(15)00134-5.

4. Messer LH, et al. The dawn of automated insulin delivery: a new clinical framework to conceptualize insulin administration. Pediatric Diabetes. 2017;19(1):14-17. doi:10.1111/pedi.12535.

5. Tanenbaum ML, et al. Optimal use of diabetes devices: clinician perspectives on barriers and adherence to device use. J Diabetes Sci Technol. 2017;11(3):484-492. doi:10.1177/1932296816688010.

6. Doyle PA, et al. Mastering medical de-vices for safe use: policy, purchasing, and training. Am J Med Qual. 2017;32(1):100-102.

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