Trial Outcomes & Findings for Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes (NCT NCT05379686)

Results Overview

This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

0 min to +105 min

Results posted on

2025-08-29

Participant Flow

This is a cross-over study. A total of 10 unique participants were enrolled and assigned to both arms sequentially. Therefore, the number of participants started in each arm is 10, but these represent the same individuals. We initially planned for 16 participants, but only 10 participants completed both visits.

Participant milestones

Participant milestones
Measure	150 ug Glucagon Before Exercise 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control No glucagon will be administered before exercise
Visit B STARTED	10	0
Visit B COMPLETED	10	0
Visit B NOT COMPLETED	0	0
Visit C STARTED	0	10
Visit C COMPLETED	0	10
Visit C NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	150 µg Glucagon Before Exercise Then No Glucagon Administered Before Exercise n=10 Participants All participants received 150 µg Glucagon before exercise during Visit B, followed by a control condition (no glucagon) during Visit C in a fixed sequence
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=10 Participants
Age, Categorical >=65 years	1 Participants n=10 Participants
Age, Continuous	50 years n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Region of Enrollment Denmark	10 participants n=10 Participants

PRIMARY outcome

Timeframe: 0 min to +105 min

This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Percentage of Time in Target Glucose Range (PG: 3.9 - 10.0 mmol/l) During and for 1-hour After Dynamic Physical Exercise Between Visit B and C	100 Percentage of time in range Interval 91.0 to 100.0	100 Percentage of time in range Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the frequency of hypoglycemic events experienced by participants over a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure evaluates the time (in minutes) taken to reach hypoglycemia during a specified monitoring period or following a specific intervention.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C	NA minutes Since no events of hypoglycaemia occured, this endpoint was not calculated.	NA minutes Since no events of hypoglycaemia occured, this endpoint was not calculated.

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C	0 percentage of time below range Interval 0.0 to 0.0	0 percentage of time below range Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C	0 percentage of time above range Interval 0.0 to 0.0	0 percentage of time above range Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the incidence rate of hyperglycemia during a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C	0 participants	0 participants

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the difference in the lowest value of plasma glucose during a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Nadir PG Concentration Between Visit B and C	5.8 mmol/l Interval 5.2 to 6.9	5.8 mmol/l Interval 4.9 to 6.5

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the difference in peak plasma glucose during a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Peak PG Concentration Between Visit B and C	9.3 mmol/l Standard Deviation 1.8	7.5 mmol/l Standard Deviation 1.4

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the difference in incremental peak of plasma glucose during a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Incremental Peak PG Concentration Between Visit B and C	1.8 mmol/l Interval 0.9 to 2.3	-0.6 mmol/l Interval -0.8 to 0.1

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the difference in mean plasma glucose during a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Mean PG Concentration Between Visit B and C	8.3 mmol/l Standard Error 1.8	6.7 mmol/l Standard Error 1.3

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the difference in plasma glucose AUC during a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in PG Area Under the Curve (AUC) Between Visit B and C	824.2 mmol/l*min Interval 782.3 to 941.2	686.2 mmol/l*min Interval 612.6 to 821.1

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the difference in SD plasma glucose during a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Standard Deviation in PG Concentrations Between Visit B and C	1.0 mmol/l Interval 0.7 to 1.2	0.5 mmol/l Interval 0.3 to 0.6

SECONDARY outcome

Timeframe: 0 min to +105 min

This outcome measure assesses the difference in CV in plasma glucose during a specified monitoring period.

Outcome measures

Outcome measures
Measure	150 ug Glucagon Before Exercise n=10 Participants 150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.	Control n=10 Participants No glucagon will be administered before exercise
Difference in Coefficient of Variation in PG Concentrations Between Visit B and C	12.3 Percentage of variation Standard Deviation 4.3	7.3 Percentage of variation Standard Deviation 2.5

Adverse Events

150 ug Glucagon Before Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr

Steno Diabetes Center Copenhagen

Phone: +45 39 68 08 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place