NCT00935129

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	OmniPod system	Patients will be treated with the OmniPod system for 12 weeks
DEVICE	Patient's conventional pump	patients will be treated with their conventional pump for 12 weeks

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-07-08
• Last updated: 2012-05-08

Locations

1 site across 1 country: Israel