Type 1 Diabetes Clinical Trial
Official title:
Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes
Verified date | February 2011 |
Source | Rabin Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Clalit Health services |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Schnider children's medical center | Petach-Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment satisfaction | Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks | No | |
Secondary | Comfort and function | Comfort and function questionnaires will be completed at weeks 0,12 and 24. | No | |
Secondary | HbA1C | HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks | No | |
Secondary | Fructosamine | Fructosamine will be measured at baseline,12 and 24 weeks | No | |
Secondary | 7 points glucose profile | diary will be completed before every clinical visit | No | |
Secondary | Pump related technical difficulties | pump related technical difficulties will be analyzed every telephone visit | No | |
Secondary | continuous glucose measurements | continuous glucose sensor will be inserted one week before visits 5 and 8 | No |
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