Type 1 Diabetes
Conditions
Keywords
Treatment satisfaction, OmniPod, Insulin pump, diabetes
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.
Interventions
DEVICEOmniPod system
Patients will be treated with the OmniPod system for 12 weeks
DEVICEPatient's conventional pump
patients will be treated with their conventional pump for 12 weeks
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment satisfaction | Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| HbA1C | HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks |
| Fructosamine | Fructosamine will be measured at baseline,12 and 24 weeks |
| Comfort and function | Comfort and function questionnaires will be completed at weeks 0,12 and 24. |
| 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 |
| 7 points glucose profile | diary will be completed before every clinical visit |
Countries
Israel
Outcome results
None listed