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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076292
• Other study ID #: 78618
• Secondary ID: 2021-001342-34
• Status: Completed
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: August 8, 2023

Study information

• Verified date: December 2023
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Drug:
• GlucaGen
150 ug or 75*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.
• Saline
Saline will be used as placebo before and after exercise.

Locations

Country	Name	City	State
Denmark	Sissel Banner Lundemose	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of hypoglycemia (PG < 3.9 mmol/l)		From 0-180 minutes post-intervention
Secondary	Percentage of time below range (PG < 3.9)		From 0-180 minutes post-intervention
Secondary	Percentage of time in range (PG = 3.9 mmol/l and = 10.0 mmol/l)		From 0-180 minutes post-intervention
Secondary	Time (min) to hypoglycemia (PG < 3.9 mmol/l)		From 0-180 minutes post-intervention
Secondary	Change in plasma glucose levels		From 0-180 minutes post-intervention
Secondary	Incidence rate of hyperglycemia (PG > 10 mmol/l)		From 0-180 minutes post-intervention
Secondary	Nadir plasma glucose concentration		From 0-180 minutes post-intervention
Secondary	Peak plasma glucose concentration		From 0-180 minutes post-intervention
Secondary	Incremental peak in plasma glucose concentration		From 0-180 minutes post-intervention
Secondary	Mean plasma glucose concentration		From 0-180 minutes post-intervention
Secondary	Plasma glucose Area Under the Curve (AUC)		From 0 to 180 min post-intervention
Secondary	Percentage of time in hyperglycemia (PG > 10 mmol/l)		From 0-180 minutes post-intervention
Secondary	Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention		From 0-180 minutes post-intervention
Secondary	Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value)		During exercise
Secondary	MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value)		During the three-day outpatient period
Secondary	MARD during the three-hour inpatient study visit (using YSI as reference value)		During exercise
Secondary	Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value)		During exercise and during the three-day outpatient period
Secondary	Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value)		During exercise and during the three-day outpatient period