E10
Conditions
Interventions
Group 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
Sponsors
Abertawe Bro Morgannwg Unviersitz Local Health Board, 1St Floor, Institute of Life Science
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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 Physical Activity Questionnaire (IPAQ) assessed). • HbA1c = 9.5 %
Exclusion criteria
Exclusion criteria: • Known or suspected hypersensitivity to trial product(s) or related products • Receipt of any investigational medicinal product within 3 months prior to screening in this trial • Known haemoglobin 2 x the upper limit of normal (ULN), bilirubin > 3 x ULN, alkaline phosphatase > 2 x ULN • Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or any clinically significant disease that might influence the participation or the study results, as judged by the Investigator • Participant with a heart rate < 40 beats per minute (bpm) at screening (after resting for 5 min in supine position) • Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) 10 at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time • Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on antihypertensives • Clinically significant abnormal ECG at screening, as judged by the Investigator • Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator • Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardize participant’s safety or compliance with the protocol • Participant known to be positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (or diagnosed with active hepatitis), for HIV-1 antibodies, HIV-2 antibodies or HIV-1 antigen • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction (except celiac disease – patient must exclude foods that contain gluten from the diet) • Participant who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening. • Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening • Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective or selective beta-blockers, growth hormone. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months • Significant history of alcoholism or drug/chemical abuse as per Investigator’s judgement. • Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day) • Not able or willing to refrain from smoking, or use of nicotine substitute products during the inpatient period • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the past 12 months). • Hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months • Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general pra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturnal hypoglycemia post-exercise; number of confirmed post-exercise nocturnal hypoglycaemic episodes between 00:01 to 05:59. | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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 hypogly | — |
Countries
United Kingdom
Contacts
Public ContactJemma Hughes
Abertawe Bro Morgannwg University Local Health Board
Outcome results
None listed