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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity College Dublin

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age between 18 and 60 years old;

being healthy individuals;

diagnosis of T1D for >18 months;

hypoglycaemia self awareness.

Disqualifiers

presence of cardiovascular disease or contraindications to exercise;

infectious or inflammatory conditions;

chronic renal or liver disease;

pregnancy;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Exercise

    Other intervention

    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

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Exercise and RestExperimental treatment 2 interventions
Group B: Rest and ExerciseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Interstitial glucose

Interstitial glucose values (mmol/l) collected via Freestyle libre 2 Continuous Glucose Monitor

Time frame
Over 2 hours: 2 samples at baseline in the fasted state before breakfast consumption; and every 5 minutes following breakfast for 2 hours.
2

Capillary glucose

Capillary glucose was measured via finger prick using a blood glucose monitor.

Time frame
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.

Secondary outcomes

1

Heart-rate variability

Measures of heart rate variability including HR, RMSSD and SSND were collected using polar monitors and chest straps.

Time frame
2 hours: (1) at baseline before breakfast consumption. (2) every 10 minutes for 120 minutes. (3) extra measurements of HR only were taken during the second thirty minutes, resulting in HR measurements at 5-minutes intervals during that time-frame.
2

Perception of symptoms of Hypoglycaemia.

100 millimetre Visual Analogue Scales (VAS) will be used. This VAS has anchors located at each end of the scale. On the left end of the scale (0 mm), the "not at all" response is represented, while the right end (100 mm) represents the "extremely" response. Participants mark along the line where it most represents their subjective perception of 7 individual symptoms of hypoglycaemia (sweatiness; anxiety; hunger; thirst; difficulties in concentrating; blurred vision; dizziness) between both ends.

Time frame
2 hours: (1) at baseline before breakfast consumption; (2) every 20 minutes for 120 minutes.
3

Reporting of Perceived Exortion (RPE)

Ratings of Perceived Exertion (RPE) were collected using the Borg 6-20 Scale. Participants were initially familiarised with the scale during their baseline visit to ensure proper understanding.

Time frame
1 hour: (1) at baseline before breakfast consumption; (2) every 5 minutes during the second half hour.

Other outcomes

Sponsors and contacts

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University College Dublin

Lead sponsor

Taighde Éireann - Research Ireland

Collaborator

Irish Research Council

Collaborator