Trial Outcomes & Findings for Biobehavioral Mechanisms of Glucose Variability (NCT NCT01835964)

Results Overview

Glucose variability in the days leading to and following the challenge was assessed by computing Low Blood Glucose Index (LBGI) on daily self-monitoring of BG (SMBG) readings. Low LBGI values correspond to lower glucose variability associated with hypoglycemic risk. LBGI values lie between 0 and 100

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

3 days

Results posted on

2023-07-07

Participant Flow

Subjects will be recruited from the Center's recruitment database.

Subject will be trained \& wear a blinded CGM for 2 days. Data will be collected about diabetes management including blood glucose data from SMBG \& CGM values along with insulin pump records throughout the 4 wk observation period. Subjects will then be admitted to the study unit for a metabolic challenge.

Participant milestones

Participant milestones
Measure	Glucose Variability Observation The study procedures will start after CGM device training \& practice using the blinded CGM for 2 days and will continue over the course of \~33 days. The study team will collect data about diabetes management including blood glucose data from fingerstick and CGM values along with insulin pump records throughout the 4 wk observation period. Insulin sensitivity will be evaluated at home with predetermined meals' carbohydrate count. At the mid-study point glucose variability (GV) will be simulated in clinic with a metabolic challenge (liquid mixed meal) followed 4h later by the induction of hypoglycemia with an intravenous insulin injection. Insulin sensitivity, as well as glucagon and epinephrine counterregulatory responses will be evaluated to be related to overall Glucose Variability. GV Observation: On the morning of \~Day 17 for a metabolic challenge involving a standardized liquid mixed meal intended to raise the blood glucose approximately 150 mg/dl, followed four hours la
Overall Study STARTED	30
Overall Study Training	30
Overall Study Observation Period	28
Overall Study Physiological Test	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biobehavioral Mechanisms of Glucose Variability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glucose Variability Observation n=28 Participants The study procedures will start after CGM device training \& practice using the blinded CGM for 2 days and will continue over the course of \~33 days. The study team will collect data about diabetes management including blood glucose data from fingerstick and CGM values along with insulin pump records throughout the 4 week observation period. Insulin sensitivity will be evaluated at home with predetermined meals' carbohydrate count. At the mid-study point glucose variability will be simulated in clinic with a metabolic challenge (liquid mixed meal) followed 4 hours later by the induction of hypoglycemia with an intravenous insulin injection. Insulin sensitivity, as well as glucagon and epinephrine counterregulatory responses will be evaluated to be related to overall Glucose Variability. Glucose Variability Observation: On the morning of \~Day 17 for a metabolic challenge involving a standardized liquid mixed meal, followed four hours later by the induction of hypoglycemia.
Age, Continuous	43 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Glucose variability in the days leading to and following the challenge was assessed by computing Low Blood Glucose Index (LBGI) on daily self-monitoring of BG (SMBG) readings. Low LBGI values correspond to lower glucose variability associated with hypoglycemic risk. LBGI values lie between 0 and 100

Outcome measures

Outcome measures
Measure	Low Hypoglycemia Exposure (Group 1) n=10 Participants To test the impact of prior exposure to low BG on the challenge effect on short-term glucose variability, the study participants were stratified in 3 different groups, based on the number of hypoglycemic episodes below 70 mg/dl they had experienced in the 2 weeks preceding the intervention. The groups were identified as follows: Group 1 - subjects who had experienced hypoglycemia once every 3 days or less, in the 2 weeks before the challenge (0 to 4 events); Group 2 - subjects who had experienced hypoglycemia approximately once every 2 days (5 to 9 events); Group 3 - subjects reporting approximately 1 or more hypoglycemic events per day (10 events or more).	Medium Hypoglycemia Exposure - Group 2 n=8 Participants To test the impact of prior exposure to low BG on the challenge effect on short-term glucose variability, the study participants were stratified in 3 different groups, based on the number of hypoglycemic episodes below 70 mg/dl they had experienced in the 2 weeks preceding the intervention. The groups were identified as follows: Group 1 - subjects who had experienced hypoglycemia once every 3 days or less, in the 2 weeks before the challenge (0 to 4 events); Group 2 - subjects who had experienced hypoglycemia approximately once every 2 days (5 to 9 events); Group 3 - subjects reporting approximately 1 or more hypoglycemic events per day (10 events or more).	High Hypoglycemia Exposure - Group 3 n=10 Participants To test the impact of prior exposure to low BG on the challenge effect on short-term glucose variability, the study participants were stratified in 3 different groups, based on the number of hypoglycemic episodes below 70 mg/dl they had experienced in the 2 weeks preceding the intervention. The groups were identified as follows: Group 1 - subjects who had experienced hypoglycemia once every 3 days or less, in the 2 weeks before the challenge (0 to 4 events); Group 2 - subjects who had experienced hypoglycemia approximately once every 2 days (5 to 9 events); Group 3 - subjects reporting approximately 1 or more hypoglycemic events per day (10 events or more).
Change Between Pre and Post Challenge Glucose Variability pre challenge	0.51 score on a scale Interval 0.4 to 0.82	1.62 score on a scale Interval 1.01 to 2.14	3.71 score on a scale Interval 1.9 to 4.34
Change Between Pre and Post Challenge Glucose Variability post challenge	0.97 score on a scale Interval 0.46 to 1.39	1.9 score on a scale Interval 1.38 to 2.52	5.42 score on a scale Interval 3.41 to 6.51

Adverse Events

Glucose Variability Observation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Glucose Variability Observation n=30 participants at risk The study procedures will start after CGM device training \& practice using the blinded CGM for 2 days and will continue over the course of \~33 days. The study team will collect data about diabetes management including blood glucose data from fingerstick and CGM values along with insulin pump records throughout the 4 week observation period. Insulin sensitivity will be evaluated at home with predetermined meals' carbohydrate count. At the mid-study point glucose variability will be simulated in clinic with a metabolic challenge (liquid mixed meal) followed 4 hours later by the induction of hypoglycemia with an intravenous insulin injection. Insulin sensitivity, as well as glucagon and epinephrine counterregulatory responses will be evaluated to be related to overall Glucose Variability.
Infections and infestations Sinus Infection	3.3% 1/30 • Number of events 1

Additional Information

Marc Breton, PhD

University of Virginia

Phone: 434-982-6484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place