| Trial ID: | L4159 |
| Source ID: | NCT00606034
|
| Associated Drug: |
U-500 Insulin Delivered By Omnipod (Disposable Insulin Pump)
|
| Title: |
U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00606034/results
|
| Conditions: |
Type 2 Diabetes|Insulin Resistance
|
| Interventions: |
DRUG: U-500 Insulin delivered by Omnipod (disposable insulin pump)
|
| Outcome Measures: |
Primary: Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c), HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline., 1 year | Secondary: Percentage of Time Spent in Hypoglycemia, For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM., baseline versus 12 months|Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ), Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method., Baseline versus 1 year
|
| Sponsor/Collaborators: |
Sponsor: Mountain Diabetes and Endocrine Center
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-12
|
| Completion Date: |
2009-07
|
| Results First Posted: |
2013-12-30
|
| Last Update Posted: |
2014-02-06
|
| Locations: |
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00606034
|
