Clinical trial NCT05076292: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia
Keywords: Type 1 Diabetes
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, single-blinded, placebo-controlled three-arm cross-over study
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence rate of hypoglycemia (PG < 3.9 mmol/l)
timeFrame: From 0-180 minutes post-intervention
Secondary outcomes:
measure: Percentage of time below range (PG < 3.9)
timeFrame: From 0-180 minutes post-intervention
measure: Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l)
timeFrame: From 0-180 minutes post-intervention
measure: Time (min) to hypoglycemia (PG < 3.9 mmol/l)
timeFrame: From 0-180 minutes post-intervention
measure: Change in plasma glucose levels
timeFrame: From 0-180 minutes post-intervention
measure: Incidence rate of hyperglycemia (PG > 10 mmol/l)
timeFrame: From 0-180 minutes post-intervention
measure: Nadir plasma glucose concentration
timeFrame: From 0-180 minutes post-intervention
measure: Peak plasma glucose concentration
timeFrame: From 0-180 minutes post-intervention
measure: Incremental peak in plasma glucose concentration
timeFrame: From 0-180 minutes post-intervention
measure: Mean plasma glucose concentration
timeFrame: From 0-180 minutes post-intervention
measure: Plasma glucose Area Under the Curve (AUC)
timeFrame: From 0 to 180 min post-intervention
measure: Percentage of time in hyperglycemia (PG > 10 mmol/l)
timeFrame: From 0-180 minutes post-intervention
measure: Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention
timeFrame: From 0-180 minutes post-intervention
measure: Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value)
timeFrame: During exercise
measure: MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value)
timeFrame: During the three-day outpatient period
measure: MARD during the three-hour inpatient study visit (using YSI as reference value)
timeFrame: During exercise
measure: Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value)
timeFrame: During exercise and during the three-day outpatient period
measure: Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value)
timeFrame: During exercise and during the three-day outpatient period
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Sissel Banner Lundemose
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Sissel B Lundemose, MD
role: PRINCIPAL_INVESTIGATOR
References: