Trial Outcomes & Findings for Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability (NCT NCT01439672)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

24 hours

Results posted on

2016-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Insulin Sensitivity Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. 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.
Overall Study STARTED	35
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Sensitivity, Impaired Counterregulation, and Glucose Variability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Sensitivity n=11 Participants Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Gender Female	4 Participants n=93 Participants
Gender Male	7 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Insulin Sensitivity n=11 Participants Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. Each subject will be admitted twice approximately 3 weeks apart. 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	3.3710^-4 1/min per uU/mL Standard Deviation 1.1810^-4

Adverse Events

Insulin Sensitivity

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Insulin Sensitivity n=35 participants at risk Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. 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.
Skin and subcutaneous tissue disorders Erythematous	2.9% 1/35 • Number of events 1
Vascular disorders Ecchymosis	2.9% 1/35 • Number of events 1

Additional Information

Sue Brown, MD

University of Virginia

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place