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Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes, Hypoglycemia

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

GlucaGen

Saline

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Exercise, Hypoglycemia, Glucagon, Continuous Glucose Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18
T1D ≥ 2 years
Use of insulin pump or MDI therapy for ≥ 6 months
Current use of insulin aspart
HbA1c ≤ 70mmol/mol (8.5%)
Body mass index (BMI) ≤ 30 kg/m2
Performs exercise ≥1 time per week

Exclusion Criteria:

Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)
Known or suspected allergies to glucagon or related products
History of hypersensitivity or allergic reaction to glucagon or lactose
Allergy to the patch of the CGM devices
Patients with pheochromocytoma, insulinoma or gastroparesis
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
Inability to understand the individual information and to give informed consent
Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation

Sites / Locations

Sissel Banner LundemoseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

150 ug glucagon before exercise

2*75 ug glucagon before exercise and after exercise

Saline as placebo

Arm Description

150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise.

75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise.

Saline as placebo will be administered in the same amount as glucagon before and after exercise.

Outcomes

Primary Outcome Measures

Incidence rate of hypoglycemia (PG < 3.9 mmol/l)

Secondary Outcome Measures

Percentage of time below range (PG < 3.9)

Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l)

Time (min) to hypoglycemia (PG < 3.9 mmol/l)

Change in plasma glucose levels

Incidence rate of hyperglycemia (PG > 10 mmol/l)

Nadir plasma glucose concentration

Peak plasma glucose concentration

Incremental peak in plasma glucose concentration

Mean plasma glucose concentration

Plasma glucose Area Under the Curve (AUC)

Percentage of time in hyperglycemia (PG > 10 mmol/l)

Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention

Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value)

MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value)

MARD during the three-hour inpatient study visit (using YSI as reference value)

Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value)

Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value)

Full Information

NCT ID

NCT05076292

First Posted

September 29, 2021

Last Updated

May 4, 2022

Sponsor

Steno Diabetes Center Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT05076292

Brief Title

Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

Official Title

Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 23, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Steno Diabetes Center Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI). The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.

Detailed Description

A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo. During the visits and in an outpatient period the participants will have 3 different CGM devices installed and the values will be compared with self-monitored blood glucose values.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Hypoglycemia

Keywords

Type 1 Diabetes, Exercise, Hypoglycemia, Glucagon, Continuous Glucose Monitoring

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

A randomized, single-blinded, placebo-controlled three-arm cross-over study

Masking

Participant

Masking Description

Single-blinded

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

150 ug glucagon before exercise

Arm Type

Experimental

Arm Description

150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise.

Arm Title

2*75 ug glucagon before exercise and after exercise

Arm Type

Experimental

Arm Description

75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise.

Arm Title

Saline as placebo

Arm Type

Active Comparator

Arm Description

Saline as placebo will be administered in the same amount as glucagon before and after exercise.

Intervention Type

Drug

Intervention Name(s)

GlucaGen

Other Intervention Name(s)

Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01

Intervention Description

150 ug or 75*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

ATC-code: Natriumklorid isotonisk "BAUER" B05BB01, V07AB

Intervention Description

Saline will be used as placebo before and after exercise.

Primary Outcome Measure Information:

Title

Incidence rate of hypoglycemia (PG < 3.9 mmol/l)

Time Frame

From 0-180 minutes post-intervention

Secondary Outcome Measure Information:

Title

Percentage of time below range (PG < 3.9)

Time Frame

From 0-180 minutes post-intervention

Title

Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l)

Time Frame

From 0-180 minutes post-intervention

Title

Time (min) to hypoglycemia (PG < 3.9 mmol/l)

Time Frame

From 0-180 minutes post-intervention

Title

Change in plasma glucose levels

Time Frame

From 0-180 minutes post-intervention

Title

Incidence rate of hyperglycemia (PG > 10 mmol/l)

Time Frame

From 0-180 minutes post-intervention

Title

Nadir plasma glucose concentration

Time Frame

From 0-180 minutes post-intervention

Title

Peak plasma glucose concentration

Time Frame

From 0-180 minutes post-intervention

Title

Incremental peak in plasma glucose concentration

Time Frame

From 0-180 minutes post-intervention

Title

Mean plasma glucose concentration

Time Frame

From 0-180 minutes post-intervention

Title

Plasma glucose Area Under the Curve (AUC)

Time Frame

From 0 to 180 min post-intervention

Title

Percentage of time in hyperglycemia (PG > 10 mmol/l)

Time Frame

From 0-180 minutes post-intervention

Title

Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention

Time Frame

From 0-180 minutes post-intervention

Title

Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value)

Time Frame

During exercise

Title

MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value)

Time Frame

During the three-day outpatient period

Title

MARD during the three-hour inpatient study visit (using YSI as reference value)

Time Frame

During exercise

Title

Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value)

Time Frame

During exercise and during the three-day outpatient period

Title

Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value)

Time Frame

During exercise and during the three-day outpatient period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 T1D ≥ 2 years Use of insulin pump or MDI therapy for ≥ 6 months Current use of insulin aspart HbA1c ≤ 70mmol/mol (8.5%) Body mass index (BMI) ≤ 30 kg/m2 Performs exercise ≥1 time per week Exclusion Criteria: Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week) Known or suspected allergies to glucagon or related products History of hypersensitivity or allergic reaction to glucagon or lactose Allergy to the patch of the CGM devices Patients with pheochromocytoma, insulinoma or gastroparesis Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception) Inability to understand the individual information and to give informed consent Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sissel B Lundemose, MD

Phone

24846602

sissel.lundemose@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sissel B Lundemose, MD

Organizational Affiliation

Steno Diabetes Center Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sissel Banner Lundemose

City

Gentofte

ZIP/Postal Code

2820

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sissel B Lundemose, MD

Phone

24846602

sissel.lundemose@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

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