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RECRUITINGINTERVENTIONAL

Inter- and Intraindividual Variability of the Acute Glucose Response to Exercise in Healthy Adults and People Living With Type 1 Diabetes: A Cross-over Replicate Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to investigate if blood glucose responses are similar between and within individuals in response to standardized exercise in adults with and without Type 1 diabetes. The main questions it aims to answer are: What is the reproducibility of acute glycaemic responses to exercise within and between subjects in adults living with Type 1 Diabetes and in healthy adults? What is the agreement between glucose levels obtained by continuous glucose monitor (CGM) and blood glucose monitor? Participants will cycle on a cycle ergometer or rest after consuming a standardized breakfast, while glucose levels are monitored by CGM and capillary blood sampling.

Who May Be Eligible (Plain English)

Who May Qualify: (Healthy and T1D phases): - age between 18 and 60 years old; - being healthy individuals; - engagement in physical activity at least once a week; (T1D phase): - diagnosis of T1D for \>18 months; - hypoglycaemia self awareness. Who Should NOT Join This Trial: (Healthy and T1D phases) - presence of cardiovascular disease or contraindications to exercise; - infectious or inflammatory conditions; - chronic renal or liver disease; - pregnancy; - gestational diabetes; - diagnosed eating disorders; - any physical or mental condition preventing participation; (Healthy phase) - diabetes mellitus (type 1 or type 2); (T1D phase) - inability to self-manage diabetes. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: (Healthy and T1D phases): * age between 18 and 60 years old; * being healthy individuals; * engagement in physical activity at least once a week; (T1D phase): * diagnosis of T1D for \>18 months; * hypoglycaemia self awareness. Exclusion Criteria: (Healthy and T1D phases) * presence of cardiovascular disease or contraindications to exercise; * infectious or inflammatory conditions; * chronic renal or liver disease; * pregnancy; * gestational diabetes; * diagnosed eating disorders; * any physical or mental condition preventing participation; (Healthy phase) * diabetes mellitus (type 1 or type 2); (T1D phase) * inability to self-manage diabetes.

Treatments Being Tested

OTHER

Exercise

After a 12h overnight fast, baseline measurements are collected. Participants are then provided with a standardized breakfast meal (60g carbohydrate). After consumption of the breakfast, participants remain seated seated for 30 minutes, before cycling on a cycle ergometer for 30 minutes at an intensity equivalent to 10% above the first ventilatory threshold (VT1). Sixty minutes of rest sitting on a chair will follow the 30-minute cycle. During the total 120 minute test, various measurements are collected at regular intervals, including: blood glucose measurements via finger prick, CGM measurements, RPE, HR, measures of heart rate variability (HRV) (RMSSD (Root Mean Square of Successive Differences) and SDNN (Standard Deviation of NN intervals)), and intensity of any hypoglycaemia-related symptoms using a Visual Analogue Scale (VAS).

OTHER

Rest

The procedure for the resting condition visits is identical to that of the exercise condition, with the only difference being that the 30-minute cycling session will be replaced by an additional 30 minutes of seated rest. This will ensure that the total duration of the session and the timing of all measurements will remain consistent across conditions.

Locations (1)

University College Dublin
Dublin, Dublin, Ireland