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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
22
Sissel Banner Lundemose
Gentofte Municipality, Denmark
Incidence rate of hypoglycemia (PG < 3.9 mmol/l)
Time frame: From 0-180 minutes post-intervention
Percentage of time below range (PG < 3.9)
Time frame: From 0-180 minutes post-intervention
Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l)
Time frame: From 0-180 minutes post-intervention
Time (min) to hypoglycemia (PG < 3.9 mmol/l)
Time frame: From 0-180 minutes post-intervention
Change in plasma glucose levels
Time frame: From 0-180 minutes post-intervention
Incidence rate of hyperglycemia (PG > 10 mmol/l)
Time frame: From 0-180 minutes post-intervention
Nadir plasma glucose concentration
Time frame: From 0-180 minutes post-intervention
Peak plasma glucose concentration
Time frame: From 0-180 minutes post-intervention
Incremental peak in plasma glucose concentration
Time frame: From 0-180 minutes post-intervention
Mean plasma glucose concentration
Time frame: From 0-180 minutes post-intervention
Plasma glucose Area Under the Curve (AUC)
Time frame: From 0 to 180 min post-intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percentage of time in hyperglycemia (PG > 10 mmol/l)
Time frame: 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
Time frame: From 0-180 minutes post-intervention
Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value)
Time frame: During exercise
MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value)
Time frame: During the three-day outpatient period
MARD during the three-hour inpatient study visit (using YSI as reference value)
Time frame: During exercise
Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value)
Time frame: 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)
Time frame: During exercise and during the three-day outpatient period