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Clinical Trial Details

Trial ID: L2595
Source ID: NCT05076292
Associated Drug: Glucagen
Title: Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Hypoglycemia
Interventions: DRUG: GlucaGen|DRUG: Saline
Outcome Measures: 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|Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l), From 0-180 minutes post-intervention|Time (min) to hypoglycemia (PG < 3.9 mmol/l), From 0-180 minutes post-intervention|Change in plasma glucose levels, From 0-180 minutes post-intervention|Incidence rate of hyperglycemia (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, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention, From 0-180 minutes post-intervention|Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value), During exercise|MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value), During the three-day outpatient period|MARD during the three-hour inpatient study visit (using YSI as reference value), During exercise|Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value), During exercise and during the three-day outpatient period|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
Sponsor/Collaborators: Sponsor: Steno Diabetes Center Copenhagen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2021-11-23
Completion Date: 2023-08-08
Results First Posted:
Last Update Posted: 2023-12-05
Locations: Sissel Banner Lundemose, Gentofte, 2820, Denmark
URL: https://clinicaltrials.gov/show/NCT05076292