Continuous Glucose Monitoring for Patients with All ... Continuous Glucose... · in intensive care...

Service Line: Rapid Response Service

Version: 1.0

Publication Date: December 21, 2018

Report Length: 15 Pages

CADTH RAPID RESPONSE REPORT: SUMMARY OF ABSTRACTS

Continuous Glucose Monitoring for Patients with All Diabetes Types: Clinical Effectiveness and Guidelines

SUMMARY OF ABSTRACTS Continuous Glucose Monitoring in Patients with All Diabetes Types 2

Authors: Deba Hafizi, Monika Mierzwinski-Urban

Cite As: Continuous Glucose Monitoring for Patients with All Diabetes Types: Clinical Effectiveness and Guidelines. Ottawa: CADTH; Dec 2018. (CADTH rapid

response report: summary of abstracts).

Acknowledgments:

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Research Questions

1. What is the clinical effectiveness of continuous glucose monitoring for patients with any

type of diabetes?

2. What are the evidence-based guidelines associated with continuous glucose monitoring

for patients with any type of diabetes?

Key Findings

Three health technology assessments and sixteen randomized control trials were identified

regarding the clinical effectiveness of continuous glucose monitoring systems for patient

with any type of diabetes. In addition, nine evidence-based guidelines associated with

continuous glucose monitoring for patients with any type of diabetes were identified.

Methods

A limited literature search was conducted on key resources including PubMed, the

Cochrane Library, University of York Centre for Reviews and Dissemination (CRD)

databases, Canadian and major international health technology agencies, as well as a

focused Internet search. Methodological filters were applied to limit retrieval to health

technology assessments, systematic reviews, meta-analyses, guidelines and randomized

controlled trials. The search was also limited to English language documents published

between January 1, 2013 and November 29, 2018. Internet links were provided, where

available.

Selection Criteria

One reviewer screened citations and selected studies based on the inclusion criteria

presented in Table 1.

Table 1: Selection Criteria

Population Patients with Type I, Type II, or gestational diabetes mellitus Pediatric population (


Results

Rapid Response reports are organized so that the higher quality evidence is presented first.

Therefore, health technology assessment reports, systematic reviews, and meta-analyses

are presented first. These are followed by randomized controlled trials and evidence-based

guidelines.

Three health technology assessments and sixteen randomized control trials were identified

regarding the clinical effectiveness of continuous glucose monitoring systems for patient

with any type of diabetes. In addition, nine evidence-based guidelines associated with

continuous glucose monitoring for patients with any type of diabetes were identified. No

relevant systematic reviews or meta-analyses were identified.

Additional references of potential interest are provided in the appendix.

Overall Summary of Findings

Three health technology assessments (HTAs)1-3 and sixteen randomized control trials

(RCTs) 4-19 were identified regarding the clinical effectiveness of continuous glucose

monitoring (CGM) systems for patient with any type of diabetes. Detailed study

characteristics are provided in Table 2.

Each HTA examined the safety and clinical effectiveness of various insulin pumps with

continuous glucose monitoring, some of which included an algorithm to suspend and restart

insulin delivery.2-3 The National Institute of Health and Care Excellence (NICE) observed

that the Space Glucose Control System was safe and effective in controlling blood glucose

in intensive care unit settings for critically ill patients with diabetes.1 An HTA by the Swedish

Council on Health Technology observed that consumers were more satisfied with sensor-

augmented pumps (SAP).2 The authors of another HTA3, observed that SAPs are

significantly favoured over multiple daily injections (MDI) and the best SAP on the market

for reducing hypoglycemic events is the Medtronic MiniMed Paradigm Veo system.3

Each of the RCTs either directly4,6,9,10,13-15,17,18 or indirectly5,7,11,12,16 examined the clinical

effectiveness of insulin pumps with CGM to improve glycemic control, reduce hypoglycemic

events, and/or consumer satisfaction in patients with either Type 1 Diabetes Mellitus (TIDM)

or Type 2 Diabetes Mellitus (TIIDM) in adult and pediatric populations. A few studies also

examined the ability of insulin pumps with CGM to detect or predict the frequency of

morning ketosis18 or in preserving beta cells in newly diagnosed patients with TIDM15 In

general, authors examining SAPs reported them to be safe and effective; however, artificial

pancreas systems were found to be superior to SAP in the management of hypoglycemia in

diabetes.5-8,11,12,16

Nine evidence-based guidelines associated with continuous glucose monitoring for patients

with any type of diabetes were identified. Detailed recommendations can be found in Table

3.

Guidelines from Health Quality Ontario recommend that CGM be publicly funded for

patients with TIDM who are willing to use CGM the majority of the time and who also meet

specific criteria. Another two guidelines from NICE21,22 also recommend CGM for children

and young people with TIDM that have severe hypoglycemic events, or cannot recognize

hypoglycemic events or communicate about the symptoms of hypoglycaemia.21 They

further recommend the Medtronic MiniMed Paradigm Veo system (SAP) as a feasible


option for managing blood glucose levels in patients with TIDM that have episodes of

disabling hypoglycemia despite optimal management with continuous subcutaneous insulin

infusion.22

Guidelines from Italy for pediatric patients with TIDM 23 recommend that the national health

services provide necessary resources such as CGM according to standards of care.

Guidelines for pediatric TIDM patients24 recommend CGM use for patients with HbA1c

levels 7% and able to use it on a nearly daily basis. There were no recommendations for

or against CGM for patients below the age of eight.24 Guidelines for adults with TIDM 24-25

recommend real-time CGM devices for adult patients who have A1C levels above target as

well as with well-controlled patients who are willing and able to use these devices on a

nearly daily basis. For adults with TIIDM, the guidelines25 suggest that real-time CGM be

used in a short-term and intermittent basis for patients with A1C levels 7% and that are

willing and able to use the device. Additionally the authors of these guidelines25 suggest

that adults with TIDM and TIIDM who use insulin pumps and CGM receive education,

training, and ongoing support to help achieve and maintain individualized glycemic goals.

The Canadian Diabetes Association guidelines27 recommends that people with TIDM use

real-time CGM to improve glycemic control. Lastly, the Standards of Medical Care in

Diabetes recommends SAP with low glucose threshold suspend systems be considered for

patients with frequent nocturnal hypoglycemia and/or hypoglycemia unawareness.28

One of the identified guidelines did not mention any specific recommendations within their

abstract.26

Table 2: Summary of Included Studies on Continuous Glucose Monitoring for Patients with All Diabetes Types

First Author,

Year

Study Characteristics

Interventions Comparators Outcomes Conclusions

Health Technology Assessments Type 1 Diabetes Mellitus

NICE 20141 Two studies included

Intensive care unit

Space GlucoseControl

None Glycemic control

Safety

Safe and effective controlling blood glucose

Swedish Council on Health Technology 20132

NR CGM SAP

None Consumer satisfaction

Clinical effectiveness

Cost-effectiveness

Consumers are most satisfied with SAP than with modern therapy

SAP improves HbA1c

Higher cost associated with CGM than strips

Riemsma 20163

19 studies, 54 publications included

CGM-pump systems:

MiniMed Paradigm Veo;

Vibe

MDI

Insulin pump with or without CGM

Glycemic control

Hypoglycemic events

SAPs significantly favoured over MDI for blood glucose control and QOL

Veo system best at reducing hypoglycemic


First Author,

Year



events

Randomized Controlled Trials Type 1 Diabetes Mellitus

Breton 20184

Adult population

N= 24

48-h visits

SAP (Dexcom G4)

Usual care insulin pump or daily injections

Glycemic Control

Improved blood glucose control and reduced hypoglycemic events safely

Ruan 20185 Adult population

N=60

Crossover design

CLC Conventional insulin pump

SAP

Nocturnal hypoglycemic events

Significantly lower risk of hypoglycemic events using CLC versus conventional pump or SAP therapy

Brown 2017 6

Adult population

N=44

SAP CLC Glycemic control

Overnight CLC was more successful in reaching glycemic targets

El-Khatib 20177

Adult population

N=43

Study length 11 days

Crossover design

AP (Bihormonal bionic pancreas)

Insulin pumps and SAP

Glycemic control

Bihormonal bionic pancreas was more successful in achieving superior glycemic regulation

Kropff 20158 Adult population

N= NR

Crossover design

Study length 2 months

AP + SAP SAP only Glycemic control

Percent time in target glucose range

The mean time spent in the target range was higher with AP than with SAP use8

AP decreased HbA1C levels significantly greater than control

Buckingham 20139

Adult population

N=19

Pilot study

Study length 21 nights

PLGS system: MiniMed Paradigm active

Inactive system Safety


Safe and feasible

Overnight hypoglycemia was lower on intervention than control nights.9

Forlenza 201810

Pediatric population

N=28

PHHM insulin pump system

PLGS insulin pump System

Safety

Glycemic control

PHHM was more effective in improving overnight glycemic control and decreasing glycemic variability compared to PLGS

Renard 201811


N=24

Hotel setting

Study length 48-h

CLC SAP (Threshold-low-glucose-suspend insulin pump)

Glycemic control


Target glucose ranges were similar for both over a 48-h period

CLC did not minimize overnight hypoglycemic event but improved time in target range11 compared to control


First Author,

Year



Tauschmann 201812


N=86

CLC SAP Glycemic control

Hypoglycemic events

CLC achieved target glycemic ranges significantly more than SAP therapy

CLC reduced risk of hypoglycemic event

Anderson 201613


N=22

Cross over design

SAP (PumpTune; uses an algorithm)

Clinician recommendations

Glycemic control

Hypoglycemic events

PumpTune was superior in achieving glycemic target range compared to clinician settings

Buckingham 201514


N=86

Study length 42 nights

PLGS system Inactive system Percent time below glycemic threshold 70mg/dL

Ketosis

PLGS substantially reduced overnight hypoglycemia

No difference in morning blood ketosis

Buckingham 201315


N=68

CLC + SAP therapy

MDI or insulin pump therapy

Beta-cell preservation (C-peptide concentration during mixed-meal tolerance tests)

In new-onset type 1 diabetes, HCLC followed by SAP therapy did not provide benefit in preserving beta-cell function compared with current standards of care.15

Sharifi 201616

Mixed population (15 adults and 12 youth)

N=28

Crossover design

CLC SAP with low-glucose suspend

Glycemic control


Consumer satisfaction

CLC in both adults and adolescents reduced nocturnal hypoglycemia and, in adults, improved overnight time in target range and treatment satisfaction compared with SAP.16

Calhoun 201617

Mixed ages

N=127

Study length 2 months

PLGS system None Glycemic control


The PLGS system was effective in preventing hypoglycemia for each factor subgroup.17

No difference in nocturnal hypoglycemic events

Beck 201418 N=45

Mixed population (15 adults and 12 youth)

Crossover design

PLGS system None Frequency of morning ketosis

Use of PLGS not a good predictor of blood or urine ketones; routine measurement with CGM not necessary


First Author,

Year



Randomized Controlled Trials Type 2 Diabetes Mellitus

Gu 201719 N=81

Adult population

Single blinded

Study length 2 weeks

SAP (MiniMed Paradigm 722 system)

MDI with blinded CGM (MiniMed CGMS System Gold)

Glycemic control


SAP vs MDI therapy in hospitalized patients with T2DM significantly reduced the time required to achieve glycaemic targets

AP=artificial pancreas; CGM = continuous glucose monitoring; CLC = closed loop control pump system; MDI = multiple daily injections; NICE=national institute of health and care excellent; NR = not reported; SAP = sensor-augmented pump which includes CGM and insulin pump; PLGS = predictive low-glucose suspend system; PHHM = predictive hyperglycemia and hypoglycemia minimization system; QOL= quality of life; SAP = sensor-augmented pumps.

Table 3: Summary of Recommendations in Included Guidelines

Author Year Recommendationsa

Type 1 Diabetes Mellitus Mixed - Adult and Pediatric Populations

Health Quality Ontario 201820

Recommends publicly funding continuous glucose monitoring in patients with type 1 diabetes who are willing to use continuous glucose monitoring for the vast majority of the time20 and who also meet the

following criteria:

An inability to recognize or communicate symptoms of hypoglycemia or

Exhibit severe hypoglycemia despite optimized use of insulin therapy and conventional blood glucose monitoring

NICE 201621 Recommends that continuous glucose monitoring is not routinely offered and should only be considered when standard management of blood glucose levels has not worked or been difficult. However, the NICE guideline for children and young people with type 1 diabetes recommends that children and young people who have severe hypoglycaemic events, or cannot recognise hypoglycaemic events or communicate about the symptoms of hypoglycaemia, should be offered continuous glucose monitoring.21

NICE 201622 NICE diagnostics guidance on integrated sensor-augmented pump therapy systems recommends the MiniMed Paradigm Veo in selected patients and in specific circumstances 1.1 The MiniMed Paradigm Veo system is recommended as an option for managing blood glucose levels in people with type 1 diabetes only if:

- they have episodes of disabling hypoglycaemia despite optimal management with continuous subcutaneous insulin infusion and

- the company arranges to collect, analyse and publish data on the use of the MiniMed Paradigm Veo system22

1.2 The MiniMed Paradigm Veo system should be used under the supervision of a trained multidisciplinary team who are experienced in continuous subcutaneous insulin infusion and continuous glucose monitoring for managing type 1 diabetes only if the person or their carer:

- agrees to use the sensors for at least 70% of the time, - understands how to use it and is physically able to use the system and - agrees to use the system while having a structured education programme on diet and lifestyle,

and counselling.22


Table 3: Summary of Recommendations in Included Guidelines

Author Year Recommendationsa

Type 1 Diabetes Mellitus Pediatric Population

Scaramuzza 201423

Recommends that the Italian National Health Service should provide all necessary resources to ensure self-monitoring of blood glucose and possibly continuous glucose monitoring of all children and adolescents with type 1 diabetes, according to the standards of care provided by these recommendations and internationally.23

Type 1 and 2 Diabetes Mellitus Adult and Pediatric Populations

Peters 201824 2.1 We recommend that RT-CGM with currently approved devices be used by children and adolescents with T1DM who have achieved glycosylated hemoglobin (HbA1c) levels below 7.0% because it will assist in maintaining target HbA1c levels while limiting the risk of hypoglycemia.24

2.2 We recommend RT-CGM devices be used with children and adolescents with T1DM who have HbA1c levels 7.0% who are able to use these devices on a nearly daily basis.24

2.3 We make no recommendations for or against the use of RT-CGM by children with T1DM who are less than 8 years of age24

In addition, same recommendations mentioned below, Peters 201625

Peters 201625 6.1 We recommend real-time continuous glucose monitoring (RT-CGM) devices for adult patients with T1DM who have A1C levels above target as well as with well-controlled T1DM and who are willing and able to use these devices on a nearly daily basis.25 6.3 We suggest short-term, intermittent RT-CGM use in adult patients with T2DM (not on prandial insulin) who have A1C levels 7% and are willing and able to use the device.25 6.4 We suggest that adults with T1DM and T2DM who use CSII and CGM receive education, training, and ongoing support to help achieve and maintain individualized glycemic goals. (Ungraded Good Practice Statement)25

Type I and Type II Diabetes Unspecified Ages

Kesavadev 201426 No specific recommendations available in abstract

Canadian Diabetes Association 201627

In people with type 1 diabetes, real-time continuous glucose monitoring may be used to improve glycemic control [Grade B, Level 2 (58)] and reduce hypoglycemia [Grade B, Level 2 (65,69)].27

Standards of Medical Care in Diabetes 201528

For patients with frequent nocturnal hypoglycemia and/or hypoglycemia unawareness, a sensor-augmented low glucose threshold suspend pump may be considered.28

NICE=National Institute of Health and Care Excellence; T1DM=type 1 diabetes mellitus; T2DM= type 2 diabetes mellitus.

a Verbatim recommendations.


References Summarized

Health Technology Assessments

Type 1 Diabetes

Adult Population

1. National Institute for Health and Care Excellence. The Space GlucoseControl system

for managing blood-glucose in critically ill patients in intensive care. (NICE Medtech

innovation briefing MIB17). London (GB): NICE; 2014:

https://www.nice.org.uk/advice/mib17/resources/the-space-glucosecontrol-system-for-

managing-bloodglucose-in-critically-ill-patients-in-intensive-care-pdf-63498989701573.

Accessed 2018 Dec 20

Mixed Population or Age Unspecified

2. Swedish Council on Health Technology Assessment. Continuous subcutaneous

glucose monitoring for diabetes. 2013; https://www.sbu.se/201304e. Accessed 2018

Dec 20.

PubMed: PM26803872

3. Riemsma R, Corro Ramos I, Birnie R, et al. Integrated sensor-augmented pump therapy

systems [the MiniMed(R) Paradigm Veo system and the Vibe and G4(R) PLATINUM

CGM (continuous glucose monitoring) system] for managing blood glucose levels in

type 1 diabetes: a systematic review and economic evaluation. Health Technol Assess.

2016 Feb;20(17):v-xxxi, 1-251.

PubMed: PM26933827

Systematic Reviews and Meta-analyses

No literature identified.

Randomized Controlled Trials

Type 1 Diabetes

Adult Population

4. Breton MD, Patek SD, Lv D, et al. Continuous glucose monitoring and insulin informed

advisory system with automated titration and dosing of insulin reduces glucose

variability in type 1 diabetes mellitus. Diabetes Technol Ther. 2018 Aug;20(8):531-540

PubMed: PM29979618

5. Ruan Y, Bally L, Thabit H, et al. Hypoglycaemia incidence and recovery during home

use of hybrid closed-loop insulin delivery in adults with type 1 diabetes. Diabetes Obes

Metab. 2018 Aug;20(8):2004-2008.

PubMed: PM29577536

6. Brown SA, Breton MD, Anderson SM, et al. Overnight closed-loop control improves

glycemic control in a multicenter study of adults with type 1 diabetes. J Clin Endocrinol

Metab. 2017 Oct 1;102(10):3674-3682.

PubMed: PM28666360

https://www.nice.org.uk/advice/mib17/resources/the-space-glucosecontrol-system-for-managing-bloodglucose-in-critically-ill-patients-in-intensive-care-pdf-63498989701573https://www.nice.org.uk/advice/mib17/resources/the-space-glucosecontrol-system-for-managing-bloodglucose-in-critically-ill-patients-in-intensive-care-pdf-63498989701573https://www.sbu.se/201304ehttp://www.ncbi.nlm.nih.gov/pubmed/26803872http://www.ncbi.nlm.nih.gov/pubmed/26933827http://www.ncbi.nlm.nih.gov/pubmed/29979618http://www.ncbi.nlm.nih.gov/pubmed/29577536http://www.ncbi.nlm.nih.gov/pubmed/28666360


7. El-Khatib FH, Balliro C, Hillard MA, et al. Home use of a bihormonal bionic pancreas

versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised

crossover trial. Lancet. 2017 Jan 28;389(10067):369-380.

PubMed: PM28007348

8. Kropff J, Del Favero S, Place J, et al. 2 month evening and night closed-loop glucose

control in patients with type 1 diabetes under free-living conditions: a randomised

crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-947.

PubMed: PM26432775

9. Buckingham BA, Cameron F, Calhoun P, et al. Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia. Diabetes Technol Ther. 2013 Aug;15(8):622-627. PubMed: PM23883408

Pediatric Population

10. Forlenza GP, Raghinaru D, Cameron F, et al. Predictive hyperglycemia and

hypoglycemia minimization: in-home double-blind randomized controlled evaluation in

children and young adolescents. Pediatr Diabetes. 2018 May;19(3):420-428.

PubMed: PM29159870

11. Renard E, Tubiana-Rufi N, Bonnemaison-Gilbert E, et al. Closed-loop driven by control-

to-range algorithm outperforms threshold-low-glucose-suspend insulin delivery on

glucose control albeit not on nocturnal hypoglycaemia in prepubertal patients with type

1 diabetes in a supervised hotel setting. Diabetes Obes Metab. 2019 Jan;21(1):183-

187.

PubMed: PM30047223

12. Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally

controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet. 2018 Oct

13;392(10155):1321-1329.

PubMed: PM30292578

13. Anderson D, Phelan H, Jones K, et al. Evaluation of a novel continuous glucose

monitoring guided system for adjustment of insulin dosing - PumpTune: a randomized

controlled trial. Pediatr Diabetes. 2016 Nov;17(7):478-482.

PubMed: PM26701831

14. Buckingham BA, Raghinaru D, Cameron F, et al. Predictive low-glucose insulin

suspension reduces duration of nocturnal hypoglycemia in children without increasing

ketosis. Diabetes Care. 2015 Jul;38(7):1197-1204.

PubMed: PM26049549

15. Buckingham B, Beck RW, Ruedy KJ, et al. Effectiveness of early intensive therapy on

beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-4035.

PubMed: PM24130350

http://www.ncbi.nlm.nih.gov/pubmed/28007348http://www.ncbi.nlm.nih.gov/pubmed/26432775http://www.ncbi.nlm.nih.gov/pubmed/23883408http://www.ncbi.nlm.nih.gov/pubmed/29159870http://www.ncbi.nlm.nih.gov/pubmed/30047223http://www.ncbi.nlm.nih.gov/pubmed/30292578http://www.ncbi.nlm.nih.gov/pubmed/26701831http://www.ncbi.nlm.nih.gov/pubmed/26049549http://www.ncbi.nlm.nih.gov/pubmed/24130350


Mixed Population Adults and Pediatric Populations

16. Sharifi A, De Bock MI, Jayawardene D, et al. Glycemia, treatment satisfaction,

cognition, and sleep quality in adults and adolescents with type 1 diabetes when using a

closed-loop system overnight versus sensor-augmented pump with low-glucose

suspend function: a randomized crossover study. Diabetes Technol Ther. 2016

Dec;18(12):772-783.

PubMed: PM27835037

17. Calhoun PM, Buckingham BA, Maahs DM, et al. Efficacy of an overnight predictive low-

glucose suspend system in relation to hypoglycemia risk factors in youth and adults with

type 1 diabetes. J Diabetes Sci Technol. 2016 Nov;10(6):1216-1221.

PubMed: PM27207890

18. Beck RW, Raghinaru D, Wadwa RP, Chase HP, Maahs DM, Buckingham BA.

Frequency of morning ketosis after overnight insulin suspension using an automated

nocturnal predictive low glucose suspend system. Diabetes Care. 2014;37(5):1224-

1229.

PubMed: PM24757229

Type 2 Diabetes

Adult Population

19. Gu W, Liu Y, Chen Y, et al. Multicentre randomized controlled trial with sensor-

augmented pump vs multiple daily injections in hospitalized patients with type 2

diabetes in China: time to reach target glucose. Diabetes Metab. 2017 Sep;43(4):359-

363.

PubMed: PM28236571

Guidelines and Recommendations

Type I Diabetes

Mixed Population Adult and Pediatric Populations

20. Health Quality Ontario. Continuous monitoring of glucose for Type 1 diabetes: OHTAC

recommendation. (Final recommendation). Toronto (ON): HQO; 2018.

http://www.hqontario.ca/Portals/0/Documents/evidence/reports/recommendation-

continuous-monitoring-of-glucose-for-type-1-diabetes-en.pdf. Accessed 2018 Dec 20.

21. National Institute for Health and Care Excellence. MiniMed 640G system with

SmartGuard for managing blood glucose levels in people with type 1 diabetes. (NICE

Medtech innovation briefing MIB51). London (GB): NICE; 2016.

https://www.nice.org.uk/advice/mib51/resources/minimed-640g-system-with-

smartguard-for-managing-blood-glucose-levels-in-people-with-type-1-diabetes-pdf-

63499221488581. Accessed 2018 Dec 20.

22. National Institute for Health and Care Excellence. Integrated sensor-augmented pump

therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed

Paradigm Veo system and the Vibe and G4 PLATINUM CGM system). (NICE

diagnostics guidance DG21). London (GB): NICE; 2016.

https://www.nice.org.uk/guidance/dg21/resources/integrated-sensoraugmented-pump-

therapy-systems-for-managing-blood-glucose-levels-in-type-1-diabetes-the-minimed-

http://www.ncbi.nlm.nih.gov/pubmed/27835037http://www.ncbi.nlm.nih.gov/pubmed/27207890http://www.ncbi.nlm.nih.gov/pubmed/24757229http://www.ncbi.nlm.nih.gov/pubmed/28236571http://www.hqontario.ca/Portals/0/Documents/evidence/reports/recommendation-continuous-monitoring-of-glucose-for-type-1-diabetes-en.pdfhttp://www.hqontario.ca/Portals/0/Documents/evidence/reports/recommendation-continuous-monitoring-of-glucose-for-type-1-diabetes-en.pdfhttps://www.nice.org.uk/advice/mib51/resources/minimed-640g-system-with-smartguard-for-managing-blood-glucose-levels-in-people-with-type-1-diabetes-pdf-63499221488581https://www.nice.org.uk/advice/mib51/resources/minimed-640g-system-with-smartguard-for-managing-blood-glucose-levels-in-people-with-type-1-diabetes-pdf-63499221488581https://www.nice.org.uk/advice/mib51/resources/minimed-640g-system-with-smartguard-for-managing-blood-glucose-levels-in-people-with-type-1-diabetes-pdf-63499221488581https://www.nice.org.uk/guidance/dg21/resources/integrated-sensoraugmented-pump-therapy-systems-for-managing-blood-glucose-levels-in-type-1-diabetes-the-minimed-paradigm-veo-system-and-the-vibe-and-g4-platinum-cgm-system-pdf-1053685217221https://www.nice.org.uk/guidance/dg21/resources/integrated-sensoraugmented-pump-therapy-systems-for-managing-blood-glucose-levels-in-type-1-diabetes-the-minimed-paradigm-veo-system-and-the-vibe-and-g4-platinum-cgm-system-pdf-1053685217221


paradigm-veo-system-and-the-vibe-and-g4-platinum-cgm-system-pdf-1053685217221.

Accessed 2018 Dec 20.

Evidence:

https://www.nice.org.uk/guidance/dg21/evidence


23. Scaramuzza A, Cherubini V, Tumini S, et al. Recommendations for self-monitoring in

pediatric diabetes: a consensus statement by the ISPED. Acta Diabetol. 2014

Apr;51(2):173-184.

PubMed: PM24162715

Type I and Type II Diabetes

Adult Population

24. Peters AL, Ahmann AJ, Hirsch IB, Raymond JK. Advances in glucose monitoring and

automated insulin delivery: supplement to Endocrine Society clinical practice guidelines.

J Endocr Soc. 2018 Nov 1;2(11):1214-1225.

PubMed: PM30324178

25. Peters AL, Ahmann AJ, Battelino T, et al. Diabetes technology-continuous

subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an

Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016

Nov;101(11):3922-3937.

PubMed: PM27588440

Type I and Type II Diabetes

Unspecified Ages

26. Kesavadev J, Sadikot S, Wangnoo S, et al. Consensus guidelines for glycemic

monitoring in type 1/type 2 & GDM. Diabetes Metab Syndr. 2014 Jul-Sep;8(3):187-195.

PubMed: PM25200925

27. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and

management of diabetes in Canada. Can J Diabetes. 2013 Apr;37(Suppl 1).

http://guidelines.diabetes.ca/App_Themes/CDACPG/resources/cpg_2013_full_en.pdf,


See: Recommendation 5, page S37

28. Standards of medical care in diabetes-2015. Diabetes Care. 2015;38(Suppl 1).

http://care.diabetesjournals.org/content/suppl/2014/12/23/38.Supplement_1.DC1/Januar

y_Supplement_Combined_Final.6-99.pdf. Accessed 2018 Dec 20.

See: Recommendation 4, page S41

https://www.nice.org.uk/guidance/dg21/resources/integrated-sensoraugmented-pump-therapy-systems-for-managing-blood-glucose-levels-in-type-1-diabetes-the-minimed-paradigm-veo-system-and-the-vibe-and-g4-platinum-cgm-system-pdf-1053685217221https://www.nice.org.uk/guidance/dg21/evidencehttp://www.ncbi.nlm.nih.gov/pubmed/24162715http://www.ncbi.nlm.nih.gov/pubmed/30324178http://www.ncbi.nlm.nih.gov/pubmed/27588440https://www.ncbi.nlm.nih.gov/pubmed/25200925https://www.ncbi.nlm.nih.gov/pubmed/25200925http://guidelines.diabetes.ca/App_Themes/CDACPG/resources/cpg_2013_full_en.pdfhttp://care.diabetesjournals.org/content/suppl/2014/12/23/38.Supplement_1.DC1/January_Supplement_Combined_Final.6-99.pdfhttp://care.diabetesjournals.org/content/suppl/2014/12/23/38.Supplement_1.DC1/January_Supplement_Combined_Final.6-99.pdf


Appendix Further Information

Previous CADTH Reports

29. A hybrid closed-loop insulin delivery system for the treatment of type 1 diabetes.

(CADTH issues in emerging helath technologies no. 155). Ottawa (ON): CADTH; 2017:

https://www.cadth.ca/sites/default/files/pdf/eh0052_hybrid_closed-

loop_insulin_delivery_system_for_the_treatment_of_type_1_diabetes.pdf. Accessed

2018 Dec 20.

30. Continuous glucose monitoring systems for pediatric patients with type 1 diabetes:

clinical and cost-effectiveness. (CADTH Rapid response report: summary of abstracts).

Ottawa (ON): CADTH; 2016:

https://www.cadth.ca/sites/default/files/pdf/htis/2016/RB1043%20CGM%20for%20Pedia

tric%20Patients%20Final.pdf. Accessed 2018 Dec 20.

31. Glucose meter use with insulin pumps: a clinical and cost effectiveness review. (CADTH

Health Technology Inquiry Service). Ottawa (ON): CADTH; 2008:

https://www.cadth.ca/sites/default/files/pdf/htis/Glucose%20Meter%20Use%20with%20I

nsulin%20Pumps%20A%20Clinical%20and%20Cost%20Effectiveness%20Review.pdf.


Systematic Reviews and Meta-Analyses

Continuous Glucose Monitor and Insulin Pump Separate

32. Pavela J, Suresh R, Blue RS, Mathers CH, Belalcazar LM. Management of diabetes

during air travel: a systematic literature review of current recommendations and their

supporting evidence. Endocr Pract. 2018 Feb;24(2):205-219.

PubMed: PM29466062

Randomized Control Trials Aritificial Pancreas

Type I Diabetes

Mixed Population Adult and Pediatric Populations

33. Russell SJ, El-Khatib FH, Sinha M, et al. Outpatient glycemic control with a bionic

pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313-325.

PubMed: PM24931572

Clinical Practice Guidelines Unspecified Methodology

Type 1 Diabetes

Adult Population

34. Choudhary P, Rickels MR, Senior PA, et al. Evidence-informed clinical practice

recommendations for treatment of type 1 diabetes complicated by problematic

hypoglycemia. Diabetes Care. 2015 Jun;38(6):1016-1029.

PubMed: PM25998294

https://www.cadth.ca/sites/default/files/pdf/eh0052_hybrid_closed-loop_insulin_delivery_system_for_the_treatment_of_type_1_diabetes.pdfhttps://www.cadth.ca/sites/default/files/pdf/eh0052_hybrid_closed-loop_insulin_delivery_system_for_the_treatment_of_type_1_diabetes.pdfhttps://www.cadth.ca/sites/default/files/pdf/htis/2016/RB1043%20CGM%20for%20Pediatric%20Patients%20Final.pdfhttps://www.cadth.ca/sites/default/files/pdf/htis/2016/RB1043%20CGM%20for%20Pediatric%20Patients%20Final.pdfhttps://www.cadth.ca/sites/default/files/pdf/htis/Glucose%20Meter%20Use%20with%20Insulin%20Pumps%20A%20Clinical%20and%20Cost%20Effectiveness%20Review.pdfhttps://www.cadth.ca/sites/default/files/pdf/htis/Glucose%20Meter%20Use%20with%20Insulin%20Pumps%20A%20Clinical%20and%20Cost%20Effectiveness%20Review.pdfhttp://www.ncbi.nlm.nih.gov/pubmed/29466062http://www.ncbi.nlm.nih.gov/pubmed/24931572http://www.ncbi.nlm.nih.gov/pubmed/25998294


Position Statements

35. Borot S, Benhamou PY, Atlan C, et al. Practical implementation, education and

interpretation guidelines for continuous glucose monitoring: a French position

statement. Diabetes Metab. 2018 Feb;44(1):61-72.

PubMed: PM29174479

36. Grunberger G, Handelsman Y, Bloomgarden ZT, et al. American Association of Clinical

Endocrinologists and American College of Endocrinology 2018 position statement on

integration of insulin pumps and continuous glucose monitoring in patients with diabetes

mellitus. Endocr Pract. 2018 Mar;24(3):302-308.

PubMed: PM29547046

37. Choudhary P, Rickels MR, Senior PA, et al. Evidence-informed clinical practice

recommendations for treatment of type 1 diabetes complicated by problematic

hypoglycemia. Diabetes Care. 2015 Jun;38(6):1016-1029.

PubMed: PM25998294

Protocols for Future Randomized Controlled Trials

Type I Diabetes

Adult Population

38. De Valk HW, Lablanche S, Bosi E, et al. Study of MiniMed 640G Insulin pump with

SmartGuard in prevention of low glucose events in adults with type 1 diabetes (SMILE):

design of a hypoglycemia prevention trial with continuous glucose monitoring data as

outcomes. Diabetes Technol Ther. 2018 Nov;20(11):758-766.

PubMed: PM30325656

39. McAuley SA, de Bock MI, Sundararajan V, et al. Effect of 6 months of hybrid closed-

loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial

protocol. BMJ Open. 2018 Jun 9;8(6):e020274.

PubMed: PM29886443


40. de Bock M, McAuley SA, Abraham MB, et al. Effect of 6 months hybrid closed-loop

insulin delivery in young people with type 1 diabetes: a randomised controlled trial

protocol. BMJ Open. 2018 Aug 13;8(8):e020275.

PubMed: PM30104309

Additional References

41. Health Quality Ontario. Continuous monitoring of glucose for type 1 diabetes: a health

technology assessment. Ont Health Technol Assess Ser. 2018;18(2):1-160.

PubMed: PM29541282

42. Hirsch IB, Verderese CA. Professional flash continuous glucose monitoring with

ambulatory glucose profile reporting to supplement A1C: rationale and practical

implementation. Endocr Pract. 2017 Nov;23(11):1333-1344.

PubMed: PM28816535

http://www.ncbi.nlm.nih.gov/pubmed/29174479http://www.ncbi.nlm.nih.gov/pubmed/29547046http://www.ncbi.nlm.nih.gov/pubmed/25998294http://www.ncbi.nlm.nih.gov/pubmed/30325656http://www.ncbi.nlm.nih.gov/pubmed/29886443http://www.ncbi.nlm.nih.gov/pubmed/30104309http://www.ncbi.nlm.nih.gov/pubmed/29541282http://www.ncbi.nlm.nih.gov/pubmed/28816535

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