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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: OmniPod system; Device: Patient's conventional pump

• Registration Number: NCT00935129
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-08
• Study Start: 2009-08
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2012-05-06
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Type 1 diabetes diagnosed at least 1 year prior to study entry
2. Use of continuous subcutaneous insulin infusion therapy for at least one year
3. Age: 18-35 years old
4. HbA1c >8.0
5. At least 4 self blood glucose measurements per day
6. No more than one severe hypoglycaemic or ketoacidosis episode within the past year and none within the past month
7. Capable of reading pump screen in English
8. Able to understand and sign subject informed consent forms

Exclusion Criteria

1. 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.
2. Patients participating in other device or drug studies
3. Clinical diagnosis of hypoglycaemic unawareness
4. Known dermal hypersensitivity to products that contain medical adhesive
5. Taking prescription medications that could complicate the management of glycemic control.
6. Inability to understand/complete the Treatment satisfaction questionnaire

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OmniPod system	OmniPod system	At this arm patients will be treated with the OmniPod system for 12 weeks
patient's conventional pump	Patient's conventional pump	At this arm patients will be treated with their conventional pump for 12 weeks

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction	Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Schnider children's medical center; 🇮🇱 Petach-Tikva, Israel