Type 1 Diabetes MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Steno Diabetes Center Copenhagen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Type 1 diabetes = 2 years • Using the AHCL system MiniMed 780G = 4 weeks • Novorapid use =1 week Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: • Allergies to lactose or glucagon • Known or suspected allergies to glucagon or related products • History of hypersensitivity or allergic reaction to glucagon or lactose • Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis • 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 • Lack of compliance with key study procedures at the discretion of the investigator • 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 enrolment 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise (visit B) versus a control trial without glucagon (visit C) on glucose responses during and after exercise in individuals with AHCL-treated T1D.;Secondary Objective: Not applicable ;Primary end point(s): 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 (0 min to +105min) between visits B and C. ;Timepoint(s) of evaluation of this end point: From 105 min post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Difference between visit B and C will be compared for the following: • Incidence rate of hypoglycaemic events (PG10.0 mmol/l) (0 min to +105min) • Incidence rate of hyperglycaemia (PG>10.0 mmol/l) (0 min to +105min) • Nadir PG concentration (0 min to +105min) • Peak PG concentration (0 min to +105min) • Incremental peak PG concentration (0 min to +105min) • Mean PG concentration (0 min to +105min) • PG Area Under the Curve (AUC) (0 min to +105min) • Standard deviation in PG concentrations (0 min to +105min) • Coefficient of variation in PG concentrations (0 min to +105min) ;Timepoint(s) of evaluation of this end point: From 105 min post-intervention | — |
Countries
Denmark
Contacts
Public ContactSissel Lundemose
Steno Diabetes Center Copenhagen
Outcome results
None listed