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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OmniPod system | Experimental | At this arm patients will be treated with the OmniPod system for 12 weeks |
|
| patient's conventional pump | Active Comparator | At this arm patients will be treated with their conventional pump for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OmniPod system | Device | Patients will be treated with the OmniPod system for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction | Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schnider children's medical center | Petah Tikva | 49202 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22283640 | Derived | Lebenthal Y, Lazar L, Benzaquen H, Shalitin S, Phillip M. Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes. Diabetes Technol Ther. 2012 May;14(5):411-7. doi: 10.1089/dia.2011.0228. Epub 2012 Jan 27. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Patient's conventional pump |
| Device |
patients will be treated with their conventional pump for 12 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |