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Clinical Trial Details

Trial ID: L6172
Source ID: NCT02882737
Associated Drug: Glucagon Before Exercise
Title: The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Glucagon before exercise|DRUG: Glucagon after exercise|DRUG: Glucagon after resting
Outcome Measures: Primary: The primary endpoint is peak plasma glucose achieved within 2 hours after the 200 μg subcutaneous glucagon injection. In the primary analysis, the investigators will compare the peak plasma glucose after exercise and after resting., 2 hours | Secondary: The time-to-peak value after glucagon injection., 2 hours|Duration of the glucagon effect; equal to the time point from glucagon injection to when plasma glucose is below baseline., 2 hours|The glycaemic effect, calculated as the total area under the curve (tAUC) after each glucagon injection., 2 hours|Changes in plasma ketone bodies after each glucagon injection., 2 hours|Changes in plasma lactic acid after each glucagon injection, 2 hours|Changes in plasma glucagon after each glucagon injection, 2 hours|Changes in serum free fatty acid (FFA) after each glucagon injection, 2 hours|Changes in serum triglycerides after each glucagon injection, 2 hours|Number of events of hypoglycemia (plasma glucose ≤3.9 mmol/l) in the three study days., 3 hours|Number of re-events of hypoglycemia (plasma glucose ≤3.9 mmol/l) 30 minutes after first event in the three study groups., 30 minutes|Number of rebound hyperglycemia (plasma glucose ≥10.0 mmol/l)., 4 hours|Mean absolute difference (MARD) in the two CGM sites during the four days after the study day using the daily 8 prespecified plasma glucose measurements by Bayer Contour Link as the reference value., 4 days|Mean absolute relative difference (MARD) during the study visits between the two sensor sites with the YSI 2300 STAT PLUS as the reference value., 6 hours|MARD during the hypoglycemia range (≤3.9 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value., 6 hours|MARD during the euglycemia range (>3.9 mmol/l and < 10.0 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference., 6 hours|MARD during the hyperglycemia range (≥10.0 mmol/l) of the study visits for the two Dexcom G4 sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value, 6 hours|MARD for the two sensor sites (CGMarm and CGMabdomen) from day 1- 7 with the Bayer Contour Link as the reference value., 7 days|The rate-of change (ROC) of the two sensors., 6 hours|The rate-of change (ROC) of plasma glucose measured by the YSI 2300 STAT PLUS., 6 hours|The Precision Absolute Relative Difference (=CGM readings of one system will be subtracted from CGM readings of the other system, and this difference will be divided by the average of the CGM readings of the abdominal sensors.), 7 days|The sensors' sensitivity and specificity to detect a hypoglycemic event., 7 days|The point accuracy of both sensors with the Clarke error grid analysis, 7 days|The pressure induced sensor attenuation (PISA) by using a recent fault detection algorithm that can detect non-physiologic anomalous low sensor readings., 7 days|The fused data from the two sensors., Fused data will be compared with data from individual sensors, 7 days
Sponsor/Collaborators: Sponsor: Hvidovre University Hospital | Collaborators: Technical University of Denmark
Gender: ALL
Age: ADULT
Phases:
Enrollment: 14
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2016-09
Completion Date: 2017-07-11
Results First Posted:
Last Update Posted: 2017-07-24
Locations: Isabelle Steineck, Hvidovre, 2650, Denmark
URL: https://clinicaltrials.gov/show/NCT02882737