USE OF CONTINUOUS SUBCUTANEOUS INSULIN INFUSION (SCII) BY ADOLESCENTS WITH TYPE I DIABETES TO OBTAIN OPTIMAL MANAGEMENT OF THE DISEASE AND ACHIEVE A BETTER QUALITY OF LIFE

Get Pumped?

Vanguard UniversityJan SchlimmerKathy ThiermannJohn Wu

Diabetes Mellitus (DM) Overview

•What is Diabetes

• Types of Diabetes

•Type 1 Diabetes Management

•What is Insulin

•Diabetic Complications

•Hemoglobin A1C

WHAT IS DIABETES

•Chronic Endocrinological disorder

•Cells stop responding to insulin or the pancreas stops producing insulin

•Elevated blood glucose concentration

TYPES OF DIABETES

Type 1- Pancreas produces little or no insulin resulting in absolute dependence on subcutaneous insulin injections.

Type 2- Although the pancreas produces insulin, the body’s utilization of insulin is poor or inadequate(insulin resistance).Treated with diet, exercise, oral medication and/or subcutaneous insulin injections.

Gestational- Increased blood glucose during pregnancy, usually temporary.

Focus of this project is on Type 1 DM

TYPE 1 DIABETES MANAGEMENT

Goal- maintain blood glucose levels near normal range

•Monitor glucose•Subcutaneous Insulin Injections• Multiple Daily Injections of Insulin

(MDII)• Continuous Subcutaneous Insulin

Infusion (CSII) via an insulin pump•Diet•Exercise

WHAT IS INSULIN

•A hormone produced by the pancreas.

•Controls the level of glucose in the blood by regulating the production and storage of glucose.

•Needed to convert glucose into energy

.

DIABETIC COMPLICATIONS•Acute Metabolic Complications- Diabetic Ketoacidosis (DKA) Hyperglycemic Hyperosmolar Nonketotic

Syndrome (HHNS)

•Long Term Effects- • Macrovascular Complications: Coronary Artery Disease,

Cerebrovascular disease, and peripheral vascular disease • Microvascular Complications: Kidney

and eye disease • Neuropathic Complications: Affecting the

nervous system.

HYPERGLYCEMIAElevated blood glucose levels

HYPOGLYCEMIA

Low blood sugar levels.

Signs and symptoms of progressive hypoglycemia include sweating, tremor, anxiety, irritability, palpitations, headache, mental dullness and sudden fatigue.

Can progress to confusion and mental disturbances, unconsciousness, seizures and death.

HEMOGLOBIN AIC

•Identifies the average plasma concentration of glucose over prolonged periods of time.

•Formed in a non-enzymatic pathway by hemoglobin's normal exposure to high plasma levels of glucose. •Monitoring the HbA1c in type-1 diabetic patients may improve treatment.

Prevalence of Type I DM•Statistics

•Type I Diabetes in Adolescents

•Adolescent Challenges in Managing Type 1 DM

•Behaviors and Attitudes Affecting Adolescent Management of Type 1 DM

•The Insulin Pump Can Better Manage Type I DM

STATISTICS

23.6 million children and adults in the United States have diabetes.

TYPE I DIABETES IN ADOLESCENTS

•Type 1 DM is approximately 10-20% of all cases of diabetes in the United States.

•Approximately one in every 400 to 600 children are adolescents with Type 1 Diabetes.

•Cause of Type 1 diabetes is unknown, a strong association between diabetes and a genetic link is indicated, although environmental factors cannot be ruled out.

ADOLESCENT CHALLENGES IN MANAGING TYPE I DM

• Must contend with puberty, which can cause a negative impact on metabolic control due to hormonal influences

• Social pressures to engage in unhealthy behaviors

• Erratic school and activity schedules, diet, stress, and depression

• Lack of sufficient diabetes knowledge and skills to manage the disease (Viklund and et al, 2007).

BEHAVIORS AND ATTITUDES AFFECTING ADOLESCENT MANAGEMENT OF TYPE I DM

• Going to bed late, sleeping late, and eating meals at varying times

• Less likely to follow diabetic treatment regimen due to social pressures

• Want to be in charge of their own lives and create their own identities

(A. Thomas, 1997)

THE INSULIN PUMP CAN BETTER MANAGE TYPE I DM

• Insulin pump therapy can offer

adolescents discreet, precise, and flexible insulin dosing,

improved long-term glycemic control, reduces the risk of diabetic complications, and improves lifestyle (Webb, 2006).

• CSII gives the adolescents a sense

of freedom and normalcy because meals no longer need to be taken at fixed times; they can sleep in, go to sleepovers, play sports, and take part in social activities without fear of hypoglycemia.

RESEARCHAccording to Cersosimo 2003, studies show that patients treated with Continuous Subcutaneous Insulin Infusion (CSII), via insulin pump, demonstrate:

• greater reductions in HbA1c

• lower rates of hypoglycemia

• less daily glucose variables

• improved clinical outcomes

• a better quality of life

Mission Statement

The mission of the project is to engage adolescents in managing their Type 1 DM with a modern, aesthetically pleasing pump that is easy to use, accurate, discrete, and will allow them to live their lives without major lifestyle changes that impact their identities as teenagers. The pump will allow for flexibility of eating and exercising habits that lead to a better quality of life.

Request for Proposal •Product Selection

•Comparison

•Which One We Chose

PRODUCT SELECTION

The 3 pumps evaluated were:

• The MiniMed Paradigm manufactured by Medtronic Diabetes

• The OmniPod manufactured by Insulet Corporation

• The OneTouch Ping manufactured by Animas Corporation

COMPARISON

Insulin Pumps

Medtronic MiniMed Paradigm

Insulet Corporation

OmniPod

Animas Corporation One Touch

PingSize 2x3x0.8 in. Pod:

1.6x2.4x0.7 in.PDM: 2.5x4.5x1

in.

Pump: 2x3.25x0.85 in.

Meter: 3.8x2.46x1.12

inWeight 3.53 oz 1.2 oz + 4.4 oz 3.9 oz + 3.88

ozInfusion Set Tubing w/Luer

lockTubeless Tubing w/Luer

lock

COMPARISON

Insulin Pumps

Medtronic MiniMed Paradigm

Insulet Corporation

OmniPod

Animas Corporation One Touch

PingAuto Insertion of cannula

No Yes No

Waterproof No Yes-up to 30 minutes

Yes- up to 24 hours

Appeal Gray scale screen

Color screen, backlights

Color screen, backlights

COMPARISON

Insulin Pumps

Medtronic MiniMed Paradigm

Insulet Corporation

OmniPod

Animas Corporation One Touch

PingBattery life Requires 1 AAA,

Alkaline, 3 weeksPDM- requires 2 AAA, alkaline, 4

weeksPod requires no

battery

Pump-requires 1 AA 1.5 Volt Lithium, 4-6

weeksMeter-requires 2

AAA

Ease of use – extra features

Vibration; colors of case; extended

bolus

Reminders and alerts; no tubing connecting pump

to pt; colors of case

Reminders and alerts; available

in Spanish; colors of case

COMPARISON

Insulin Pumps

Medtronic MiniMed Paradigm

Insulet Corporation

OmniPod

Animas Corporation One Touch

PingFood Database

No Yes – 1000 foods Yes- 500 foods

Interacts with Blood Glucose Meter?

Yes – wireless up to 4 feet

Yes- built into pod, wireless up

to 2 feet

Yes- wireless up to 10 feet

Interacts with Continuous Glucose Monitor?

Yes – real time CGM relays

readings to pump

No No

WHICH ONE WE CHOSE…

OMNIPOD INSULIN MANAGEMENT SYSTEM

THE OMNIPOD SYSTEM

THE OMNIPOD

THE PERSONAL DIABETES MANAGER (PDM)

THE OMNIPOD SYSTEM

No tubing Automated priming &

cannula insertion Integrated FreeStyle® blood

glucose meter, bolus calculator, food reference library

Fewest steps to starting insulin delivery*

CSII therapy in a discreet, wireless, easy-to-use system

THE OMNIPOD

A compact, lightweight self-adhesive insulin infusion device

Worn for up to 3 days and replaced Eliminates tubing and corresponding snagging and disconnecting Provides patients with discreet insulin delivery and freedom of

movement for daily activities and sports Completely waterproof IPX-8

THE PERSONAL DIABETES MANAGER (PDM)

Wireless handheld device that programs the OmniPod’s insulin delivery

Features intuitive programming and simple instructions

Integrates a FreeStyle blood glucose meter, bolus calculator and food reference library

Bright LCD backlit screen and light-port at testing strip site for ease of use in dark settings

Stores, displays and downloads insulin delivery, blood glucose and carbohydrate records

Provides patients with discreet means for programming insulin delivery

Implementation•Requirements for adolescents to use the insulin pump

•First Stage – Initial Inquiry

•Second Stage – Pre-Training /Preparation/In-Person Training

•Stage Three – Continuing Education

•References

REQUIREMENTS FOR ADOLESCENTS TO USE THE INSULIN PUMP

• A knowledge base of Type I diabetes

• A positive attitude towards diabetes management

• An understanding of the insulin pump and how it operates

• A positive support system

FIRST STAGE – INITIAL INQUIRY • Website provides local contact

information available for the adolescent and family.

• OmniPod’s online service provides information about the disease process and how the device assists adolescents to control their Type 1 diabetes, while not compromising their daily life style but enhancing their quality of life.

• OmniPod offers a free demo pod that the adolescent can wear. The non-working pod is designed to give the adolescent the sense of how the pod looks and feels when worn.

SECOND STAGE – PRE-TRAINING PREPARATION/IN-PERSON TRAINING

The website offers an Interactive Training Program which contains a broad range of in-depth training:

• Pump Therapy Basics: Understand the difference between basal and bolus doses, and how to determine what you need.

• OmniPod System Overview: Gain insight into the way the system works and how it can make diabetes a smaller part of your life.

SECOND STAGE – PRE-TRAINING PREPARATION/IN-PERSON TRAINING

• An interactive, simulated PDM: See step-by-step instructions for programming the PDM.

• In-depth Training: Go far beyond “basics” when you follow detailed instructions on changing the Pod, testing your blood glucose and using the PDM’s advanced settings.

• Diabetes Resources: Read helpful sections on nutrition, exercise, handling sick days, being away from home and avoiding highs and lows.

The adolescent should review the Pre-Training Preparation section before meeting the trainer.

SECOND STAGE – PRE-TRAINING PREPARATION/IN-PERSON TRAINING

• After completing the pre-training preparation, a Certified Pod Trainer offers hands-on detailed instruction on how to use the device, including programming the PDM with personal settings, starting the first Pod and answering all questions.

• Both the adolescent and their families should be encouraged to ask questions prior to making the final decision to begin with the OmniPod Insulin Management System.

STAGE THREE – CONTINUING EDUCATION

• Continuing education is an on-going process for both the adolescent and their family.

• The adolescent’s diabetes management will be evaluated by the healthcare provider and the adolescent as to how the OmniPod has improved the adolescent’s quality of life.

• OmniPod offers a Customer Care Hotline 24/7

REFERENCES

• American Diabetes Association (2007) Http;//www.diabetes.org/diabetes-basics/diabetes-satistic

• Baker, LR, Burton, JR., and Vieve, PD. Principles of Ambulatory Medicine Sixth edition(1183). Philadelphia, PA: Liptincott Williams & Wilkins: 2003

• Cersosimo, E. (2003). To Pump or Not to Pump. Diabetes Care , 967.• George, C. (2009). Future trends in diabetes management. Nephrology

Nursing Journal, 477-483. • E. Muller-Godeffroy, S. T. (2009). Education and Psychological Aspects

Investigation of Quality of Life and Family Burden Issues During Insulin Pump Therapy in Children with Type I Diabetes Mellitus- a large-scale multicenter pilot study. Diabetic Medicine , 493-501.

• Melville, B. (2005). The insulin pump: why not use it for every type1 Diabetic patient?. Critical Care Nursing Quarterly, 28(4), 370-377.

• Smeltzer, C., Suzanne, Bare, G., Brenda, Hinkle, L., Janice, and Cheever, H., Kerry. (2008) Assessment and Management of Patients With Diabetes Mellitus. In P, Darcy (Ed). Textbook of Medical-Surgical Nursing Eleventh Edition(pp1376 -1377). Philadelphia, PA: LWW

REFERENCES

• Thomas, L. P. (1997). Problem solving and diabetes regimen adherence

by children and adolescents with IDDM in social pressure situations: a reflection of normal development. Journal of Pediatric Psychology 541-561.

• Viklund, G., Rudberg, S., and Wikblad, K.F. (2007). Teenager with diabetes: Self-management education and training on a big schooner. International Journal of Nursing Practice. 13, 385-392

• Webb, K. (2006) Use of insulin pump for diabetic management. MEDSURG Nursing, 15(2), 61-94

• Weinzimer, S., Ahern, J., Doyle, E., Vincent, M., Dziura, J., Steffen, A., et al. (2004). Persistence of Benefits of Continuous Subcutaneous Insulin Infusion in Very Young Children With Type 1Diabetes; A Follow-up Report. Pediatrics, 114 (6), 1601-1605.

• Ziemberg, T. (2001). The Medtronic MiniMed certified pump trainer manual. Sylmar, CA:Medtronic MiniMed, INC.