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 University Jan Schlimmer Kathy Thiermann John Wu
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.