Trial Outcomes & Findings for The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes (NCT NCT02660242)

Results Overview

Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)

Results posted on

2020-03-03

Participant milestones
Measure	MIni-dose Glucagon Crossover Trial Each participant will undergo four aerobic exercise sessions (in random order) of a) a Control Trial: Fasted exercise, no basal insulin reduction; b) Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate five minutes before exercise, for the duration of the exercise); c) Strategy 2: Fasted exercise, no basal adjustment + pre-exercise and mid-exercise glucose tabs (buccal route-40 grams in total); d) Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc). Each period includes 0-165 minutes in the lab and the participant continues to wear a continuous glucose monitor during the afternoon, overnight, and through noon the following day.
Control STARTED	16
Control COMPLETED	16
Control NOT COMPLETED	0
Basal Insulin Reduction STARTED	16
Basal Insulin Reduction COMPLETED	16
Basal Insulin Reduction NOT COMPLETED	0
Glucose Tabs STARTED	16
Glucose Tabs COMPLETED	15
Glucose Tabs NOT COMPLETED	1
Glucagon Injection STARTED	16
Glucagon Injection COMPLETED	15
Glucagon Injection NOT COMPLETED	1

Reasons for withdrawal
Measure	MIni-dose Glucagon Crossover Trial Each participant will undergo four aerobic exercise sessions (in random order) of a) a Control Trial: Fasted exercise, no basal insulin reduction; b) Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate five minutes before exercise, for the duration of the exercise); c) Strategy 2: Fasted exercise, no basal adjustment + pre-exercise and mid-exercise glucose tabs (buccal route-40 grams in total); d) Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc). Each period includes 0-165 minutes in the lab and the participant continues to wear a continuous glucose monitor during the afternoon, overnight, and through noon the following day.
Glucose Tabs Lost to Follow-up	1
Glucagon Injection Lost to Follow-up	1

The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

Baseline characteristics by cohort
Measure	Entire Study Population n=15 Participants Includes all patients who completed the crossover trial.
Age, Continuous	30 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Type 1 Diabetes Duration, Continuous	22 years n=5 Participants
HbA1c	6.8 % n=5 Participants
Body Mass Index (BMI)	24 kg/m^2 n=5 Participants
VO2Max	42 mL/kg/min n=5 Participants

Timeframe: 0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)

Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.

Outcome measures
Measure	Control n=15 Participants No basal insulin adjustment, no carbohydrate intake (until glucose drops \<70 mg/dL).	Basal Insulin Reduction n=15 Participants Basal insulin reduction to 50% 5 minutes before the start of exercise.	Glucose Tabs n=15 Participants Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).	G-Pen Mini™ (Glucagon Injection) n=15 Participants Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Glycemic Response During Exercise and Early Recovery Plasma Glucose Concentration (End of Exercise)	86 mg/dL Standard Deviation 30	85 mg/dL Standard Deviation 25	174 mg/dL Standard Deviation 59	161 mg/dL Standard Deviation 39
Glycemic Response During Exercise and Early Recovery Plasma Glucose Concentration (End Early Recovery)	90 mg/dL Standard Deviation 34	92 mg/dL Standard Deviation 34	222 mg/dL Standard Deviation 66	163 mg/dL Standard Deviation 49

Timeframe: 0 to 75 minutes following exercise initiation

Comparison of occurrence of hypoglycemia (\<70 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.

Outcome measures
Measure	Control n=15 Participants No basal insulin adjustment, no carbohydrate intake (until glucose drops \<70 mg/dL).	Basal Insulin Reduction n=15 Participants Basal insulin reduction to 50% 5 minutes before the start of exercise.	Glucose Tabs n=15 Participants Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).	G-Pen Mini™ (Glucagon Injection) n=15 Participants Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery	6 Participants	5 Participants	0 Participants	0 Participants

Timeframe: 0 to 75 minutes following exercise initiation

Comparison of occurrence of hyperglycemia (≥250 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.