Influence of adjusting rapid-acting insulin aspart on post-exercise nocturnal hypoglycaemia in recreationally active people with type 1 diabetes on insulin degludec

Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2019
INTERVENTION: Intervention 1: Pre‐ExFull The influence of a full (100%) dose of bolus insulin pre‐ and post‐continuous aerobic exercise on the occurence of nocturnal hypoglycaemia in patients with type 1 diabetes with an unaltered background of insulin degludec. Intervention 2: Pre‐Ex50 The influence of a reduced (50%) bolus insulin dose pre‐continous aerobic exercise with a post‐exercise full dose (100%) of bolus insulin on the occurence of nocturnal hypoglycaemia in patients with type 1 diabetes with an unaltered background of insulin degludec. Intervention 3: Post‐ExFull The influence of a full (100%) bolus insulin dose pre‐continous aerobic exercise with a post‐exercise reduced dose (50%) of bolus insulin on the occurence of nocturnal hypoglycaemia in patients with type 1 diabetes with an unaltered background of insulin degludec. Intervention 4: Post‐Ex50 The influence of a reduced (50%) dose of bolus insulin pre‐ and post‐continuous aerobic exercise on the occurence of nocturnal hypoglycaemia in patients with type 1 diabetes with an unaltered background of insulin degludec. CONDITION: E10 ‐ Type 1 diabetes mellitus PRIMARY OUTCOME: Nocturnal hypoglycemia post‐exercise; number of confirmed post‐exercise nocturnal hypoglycaemic episodes between 00:01 to 05:59. INCLUSION CRITERIA: • Informed consent obtained before any trial‐related activities. Trial‐related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. • Male or female aged 18‐65 years (both inclusive). • Type 1 diabetes mellitus (as diagnosed clinically) = 12 months. • Treated with multiple daily insulin injections = 12 months • Body mass index 18.0‐29.4 kg/m2 (both inclusive). • If patients’ BMI is above 29.4 kg/m2 due to muscular hypertrophy, the bioelectrical impendence analysis (BIA) will be used as a further assessment criterion. If patients’ fat‐free mass (%) is within ±5% of normal reference values the investigators can include the patient. • Mass‐specific VO2peak >20 mlO2/kg body weight/min. • Participants performing regular physical cardiorespiratory activity (physically active for at least 30 min at a time, three times per week) (short International Ph SECONDARY OUTCOME: • Blood glucose changes with exercise (BGpre‐exercise to lowest BG during exercise (BGnadir,exercise); • BG mean exercise, mean blood glucose concentration from 0 to 45 minutes during exercise.; • BG 45min exercise, blood glucose concentration after 45 minutes of exercise.; • BG pre‐exercise – BG 45min of exercise, difference in blood glucose concentration from immediate pre‐exercise until 45 minutes of exercise. ; • BG Minimum during exercise, minimum blood glucose concentration during exercise.; • FGM exercise, blood glucose profile based on continuous glucose monitoring during exercise.; • Hypoexercise, number of confirmed hypoglycaemic episodes during exercise.; • CHO exercise, number of carbohydrate administrations given during exercise in response to hypoglycaemia.; ; The following endpoints will be derived for the period following exercise:; ; • BG Mean from 60‐180 min post‐exercise meal, mean blood glucose concentration between 60 and 180 minutes post‐exercise meal.; • BG Minimum from 60‐180 min post‐exercise meal, minimum blood glucose concentration between 60 and 180 minutes post‐exercise meal. ; • tBG Minimum,60‐180min,Post‐exercise meal, time from start of post‐exercise meal until minimum blood glucose concentration between 60 and 180 minutes post‐exercise meal. ; • 11‐point blood glucose profile during the 13 hours post‐exercise.; • Next morning fasting BG concentration.; • FGM14 hour post‐exercise, blood glucose profile based on continuous interstitial glucose monitoring during 14 hours post‐exercise.; • FGM 24 hour post‐lab, blood glucose profile based on continuous interstitial glucose monitoring during 24 hours after leaving the laboratory.; • Hypo 24 hour post‐exercise, number of confirmed hypoglycaemic episodes during 24 hours post‐exercise.; • Number of nocturnal hypoglycaemic occurrences determined using interstitial FGM following exercise; • CHO 24hour post‐exercise, number of carbohydrate administrations given during 24 hours post‐exercise in response to hypoglycaemia.; • Counter‐regulatory hormone and ketones monitored over experimental period
Epistemonikos ID: a677b895be1de0c91c620bed90f6adf633e6f73b
First added on: Aug 24, 2024