U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
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|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|
|Actual Primary Completion Date :||July 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|