Advancing automated insulin delivery for exercise to improve the daily lives of people with type 1 diabetes

• Register: ANZCTR
• Last refreshed on: 12 November 2018
• Main ID: ACTRN12618000905268
• Date of registration: 29/05/2018
• Prospective Registration: Yes
• Primary sponsor: St Vincent's Hospital Melbourne
• Public title: Advancing automated insulin delivery for exercise to improve the daily lives of people with type 1 diabetes
• Scientific title: Assessing exercise-related parameters during closed-loop insulin delivery to advance closed-loop systems for people with type 1 diabetes
• Date of first enrolment: 13/06/2018
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000905268.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia, Canada

Contacts

• Name: Ms Catriona Sims

• Name: Dr Sybil McAuley

Key inclusion & exclusion criteria

Inclusion criteria: Type 1 diabetes for >1 year
Insulin pump therapy for >6 months
HbA1c <9% (<75 mmol/mol)
Able to undertake high-intensity exercise
Exclusion criteria: Renal impairment with eGFR <45 mL/min/1.73 m^2
Insulin dose >150 units/day
Untreated cardiovascular disease
Diabetic ketoacidosis or systemic steroid therapy within past month
Severe visual impairment
Pregnancy
Untreated thyroid, adrenal or coeliac disease

Age minimum: 12 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Type 1 diabetes;
Type 1 diabetes

Metabolic and Endocrine - Diabetes

Intervention(s)

All procedures involving study participants will be undertaken by study doctors, nurses and scientists. Participants will be directly supervised by research personnel for all study activities in the clinical trial centre (CTC), including exercise. Maximal cardiopulmonary exercise testing (VO2max) will be assessed on a stationary bicycle over 15 min. Maximal strength (3-lift max) will be measured. Participants will be provided with study devices and receive education regarding their use. Transcutaneous glucose sensors will be worn for continuous glucose monitoring (CGM) during the study. A study insulin pump will be programmed with the participant’s individualised insulin delivery settings and paired with the CGM.

Participants will undertake three exercise stages in random order, separated by 1–4 weeks (timing determined by participant availability). The exercise intervention bouts within the respective stages are: (i) moderate-intensity exercise (MIE) on a stationary bicycle [32 min continuous exercise at 40% maximal intensity]; (ii) high-intensity interval exercise (HIIE) on a stationary bicycle [4 × 4 min intervals at 80% maximal intensity with 4 min rest between intervals]; and (iii) resistance exercise (RE) involving a circuit of five compound resistance exercises (e.g. leg press, seated row) each performed for 8-12 repetitions and completed 3 times (resistance weight at 80% 3–lift max).

Four days prior to each exercise bout, closed loop (CL) automated insulin delivery mode will be initiated on the insulin pump. Prior to each exercise bout, participants will eat a standardised lunch (with 40 g carbohydrate, 25 g protein and 10 g fat) at midday, then attend the CTC early afternoon. Accelerometers (wrist and ankle) and electrocardiogram leads will be attached, and an intravenous cannula will be inserted for sample collection. During the HIIE stage only, a prototype lactate sensor will be inserted subcutaneously in the anterior abdomen and attached to

Primary Outcome(s)

Proportion of time spent with sensor glucose 3.9–10 mmol/L[0–14 h after commencement of each exercise bout (primary timepoint); during each exercise bout; 0–4 h after completion of each exercise bout; and 4–13 h after completion of each exercise bout]

Secondary Outcome(s)

Glucose variability measured by coefficient of variation[0–14 h after commencement of each exercise bout; during each exercise bout; 0–4 h after completion of each exercise bout; and 4–13 h after completion of each exercise bout]

Change in heart rate (assessed by electrocardiogram)[From 1 h prior to exercise commencement until 4 h post-exercise completion for each exercise bout]

Change in plasma glucose levels[From 1 h prior to exercise commencement until 4 h post-exercise completion for each exercise bout]

Proportion of time spent with sensor glucose >10.0 mmol/L[0–14 h after commencement of each exercise bout; during each exercise bout; 0–4 h after completion of each exercise bout; and 4–13 h after completion of each exercise bout]

Change in glucose counter-regulatory hormones levels[From 1 h prior to exercise commencement until 4 h post-exercise completion for each exercise bout]

Sensor glucose positive incremental area under the curve (AUC) following the Wolever method[0–14 h after commencement of each exercise bout; during each exercise bout; 0–4 h after completion of each exercise bout; and 4–13 h after completion of each exercise bout]

Change in plasma insulin levels[From 1 h prior to exercise commencement until 4 h post-exercise completion for each exercise bout]

Change in blood ketone levels[From 1 h prior to exercise commencement until normalisation (up to 8 h post-exercise completion) for each exercise bout]

Proportion of time spent with sensor glucose <3.9 mmol/L for at least 15 min[0–14 h after commencement of each exercise bout; during each exercise bout; 0–4 h after completion of each exercise bout; and 4–13 h after completion of each exercise bout]

Change in plasma lactate levels[From 1 h prior to exercise commencement until 4 h post-exercise completion for each exercise bout]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

JDRF International and The Leona M. and Harry B. Helmsley Charitable Trust

Secondary Sponsor(s)

York University

John Hunter Children's Hospital

Ethics review

Status: Approved
Approval date:
Contact:

St Vincent's HREC