U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
|ClinicalTrials.gov Identifier: NCT00606034|
Recruitment Status : Completed
First Posted : February 1, 2008
Results First Posted : December 30, 2013
Last Update Posted : February 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Insulin Resistance||Drug: U-500 Insulin delivered by Omnipod (disposable insulin pump)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens|
|Study Start Date :||December 2007|
|Primary Completion Date :||July 2009|
|Study Completion Date :||July 2009|
Experimental: All subjects active
All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Drug: U-500 Insulin delivered by Omnipod (disposable insulin pump)
U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs
- Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c) [ Time Frame: 1 year ]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.
- Percentage of Time Spent in Hypoglycemia [ Time Frame: baseline versus 12 months ]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.
- Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ) [ Time Frame: Baseline versus 1 year ]Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606034
|United States, North Carolina|
|Mountain Diabetes and Endocrine Center|
|Asheville, North Carolina, United States, 28803|
|Principal Investigator:||Wendy S Lane, MD||Mountain Diabetes and Endocrine Center|