An interventional study of OmniPod system and Patient's conventional pump in Type 1 Diabetes, sponsored by Rabin Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2012-05-08.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Treatment
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.
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
At this arm patients will be treated with the OmniPod system for 12 weeks
Device: OmniPod system
At this arm patients will be treated with their conventional pump for 12 weeks
Device: Patient's conventional pump
Patients will be treated with the OmniPod system for 12 weeks
patients will be treated with their conventional pump for 12 weeks
Treatment satisfaction
Time frame: Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks
Comfort and function
Time frame: Comfort and function questionnaires will be completed at weeks 0,12 and 24.
HbA1C
Time frame: HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks
Fructosamine
Time frame: Fructosamine will be measured at baseline,12 and 24 weeks
7 points glucose profile
Time frame: diary will be completed before every clinical visit
Pump related technical difficulties
Time frame: pump related technical difficulties will be analyzed every telephone visit
continuous glucose measurements
Time frame: continuous glucose sensor will be inserted one week before visits 5 and 8
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Rabin Medical Center