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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Interstitial glucose — Over 2 hours: 2 samples at baseline in the fasted state before breakfast consumption; and every 5 minutes following breakfast for 2 hours.
  Interstitial glucose values (mmol/l) collected via Freestyle libre 2 Continuous Glucose Monitor
• Capillary glucose — 2 hours: (1) at baseline before breakfast consumption; (2) every 10 minutes over 30 minutes after breakfast consumption during rest; (3) every 5 minutes for 30 minutes during cycle or seated rest based on intervention; (4) every 10 minutes for 60 min.
  Capillary glucose was measured via finger prick using a blood glucose monitor.

Trial sites (1)

More University College Dublin trials in Ireland

Other trials for the same condition