Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes

Study Overview
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Brief Summary
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Randomized, two arms, open study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes. The study will include two consecutive 12 weeks treatment periods. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.

Detailed Description
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A Randomized, two arms, open, crossover study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes. The study will include two consecutive 12 weeks treatment periods. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa. Study will consist of 4 clinic visits taking place at -2,0,12 and 24 weeks and additional 4 telephone visits taking place at 4,8,16 and 20 weeks. In addition, patients will be invited one week prior to visit 5 and visit 8 in order to insert a continuous glucose sensor. Patients will complete DTSQ and Comfort & Function questionnaires at weeks 0, 12 and 24, before and at the end of each study arm. On each clinical visits the following parameters will be evaluated: vital signs, HbA1c, 4 and 7 points glucose profile, hypoglycemia events, hyperglycemia events and pump related technical problems. The telephone visits will include pump related technical problems solving and AE/SAE reporting.

Official Title
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Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: OmniPod system
* Device: Patient's conventional pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes diagnosed at least 1 year prior to study entry Use of continuous subcutaneous insulin infusion therapy for at least one year Age: 18-35 years old HbA1c >8.0 At least 4 self blood glucose measurements per day No more than one severe hypoglycaemic or ketoacidosis episode within the past year and none within the past month Capable of reading pump screen in English Able to understand and sign subject informed consent forms Exclusion Criteria: Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study. Patients participating in other device or drug studies Clinical diagnosis of hypoglycaemic unawareness Known dermal hypersensitivity to products that contain medical adhesive Taking prescription medications that could complicate the management of glycemic control. Inability to understand/complete the Treatment satisfaction questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OmniPod system<br>At this arm patients will be treated with the OmniPod system for 12 weeks | Device: OmniPod system<br>* Patients will be treated with the OmniPod system for 12 weeks<br>|
| Active Comparator: patient's conventional pump<br>At this arm patients will be treated with their conventional pump for 12 weeks | Device: Patient's conventional pump<br>* patients will be treated with their conventional pump for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction |  | Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort and function |  | Comfort and function questionnaires will be completed at weeks 0,12 and 24. | 
| HbA1C |  | HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks | 
| Fructosamine |  | Fructosamine will be measured at baseline,12 and 24 weeks | 
| 7 points glucose profile |  | diary will be completed before every clinical visit | 
| Pump related technical difficulties |  | pump related technical difficulties will be analyzed every telephone visit | 
| continuous glucose measurements |  | continuous glucose sensor will be inserted one week before visits 5 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment satisfaction, OmniPod, Insulin pump, diabetes