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 • 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 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the efficacy of single-administration low-dose (150 µg) s.c. glucagon and split-administration low-dose (2 x 75 µg) s.c. glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI). ;Secondary Objective: The secondary objective is to compare the accuracy of three continuous glucose monitors - Dexcom G6, FreeStyle Libre 2 and Guardian 4 during and after exercise in inpatient and outpatient settings.;Primary end point(s): The primary endpoint is: Incidence rate of hypoglycemia (PG < 3.9 mmol/l) from 0-180 minutes post-intervention ;Timepoint(s) of evaluation of this end point: From 180 minutes post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • Percentage of time below range (PG 10 mmol/l) from 0-180 minutes post-intervention • Nadir plasma glucose concentration from 0-180 minutes post-intervention • Peak plasma glucose concentration from 0-180 minutes post-intervention • Incremental peak in plasma glucose concentration from 0-180 minutes post-intervention • Mean plasma glucose concentration from 0-180 minutes post-intervention • Plasma glucose Area Under the Curve (AUC) from 0 to 180 min post-intervention • Percentage of time in hyperglycemia (PG > 10 mmol/l) from 0-180 minutes post-intervention • Change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention (tintervention = 180) 1A sub-analysis looking at the 60-minutes exercise session and 2-hour observation period separately will also be conducted. The secondary CGM endpoints are the difference between the Dexcom G6, FreeStyle Libre 2 and Guardian 4 sensors in: • 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) ;Timepoint(s) of evaluation of this end point: From 0-180 minutes post-intervention (unless specified otherwise in the Secondary endpoints" section) | — |
Countries
Denmark
Contacts
Public ContactSissel Lundemose
Steno Diabetes Center Copenhagen
Outcome results
None listed