Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability (BPK005)
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|ClinicalTrials.gov Identifier: NCT01439672|
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : April 14, 2015
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Dietary Supplement: Mixed meal and insulin challenge||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: Insulin Sensitivity
Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.
Dietary Supplement: Mixed meal and insulin challenge
The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100.
- Insulin Sensitivity [ Time Frame: 24 hours ]Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge.
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): NCT01439672
|United States, Virginia|
|University of Virginia, Center for Diabetes Technology|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Sue Brown, MD||University of Virginia|