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Type 1 DiabetesNCT04383015

Carbohydrate and Insulin Requirements During Prolonged Fasted Exercise

A study testing Exercise strategies in people with Type 1 Diabetes, run by York University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different management strategies for prolonged aerobic exercise: A) carbohydrate dose of 0.3g/kg/hr; B) A 50 percent basal rate reduction, performed 90-minutes in advance of… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Exercise strategies
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
31 Oct 2018to 17 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of presumed autoimmune type 1 diabetes
  • Last HbA1c ≤ 9.9 percent
  • Age: 17+ years
  • Duration of T1D: ≥ 1.5 years
  • Using insulin pump therapy: ≥3 months (at least 0.25 units of insulin per kilogram of body mass)
  • In good general health with no conditions that could impact the outcome of the trial
  • Willing to adhere to the protocol requirements for the duration of the study

Who cannot join

  • Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
  • Physician diagnosis of peripheral neuropathy or autonomic neuropathy
  • Medications:
  • Beta-blockers
  • Agents that affect hepatic glucose production (xanthine derivatives)
  • Pramlintide
Show all 9Show fewer
  • Any other hypoglycemic agent
  • Participation in other studies involving the administration of an investigational drug or device during the duration of the current study
  • Severe hypoglycemia in the last 3 months, defined as the individual requiring third party assistance or hospitalization

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • York University

    Toronto, Ontario, M3J1P3

Other trials in Canada

About this study

Official title: Carbohydrate Requirements for Prolonged, Fasted Exercise With and Without Basal Rate Reductions in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion

The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different management strategies for prolonged aerobic exercise: A) carbohydrate dose of 0.3g/kg/hr; B) A 50 percent basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) A 50 percent basal rate reduction, performed at exercise onset, with carbohydrate dose of 0.3g/kg/hr

Read the detailed description

This project focuses on the effectiveness of various exercise strategies on the time spent in target range during and after aerobic exercise in adults with type 1 diabetes (T1D) on continuous subcutaneous insulin infusion (CSII).

The primary objective of the protocol is to determine if a moderate basal insulin reduction (-50 percent of basal), performed 90-minutes before a 120-minute aerobic exercise session (with 5-minute breaks every 30 minutes of exercise, and a ten minute break mid-exercise), improves the time in target range compared to either a carbohydrate consumption only strategy or insulin reduction (-50 percent) and carbohydrate consumption strategy both performed at the onset of exercise in patients with T1D on CSII therapy. The time in target will be determined for both the exercise period and during a 24-hour window after the end of exercise.

In all three sessions, aerobic exercise (brisk walking) will be performed in the fasted state (minimum 8 hours after the last meal) in the early-morning. The exercise will consist of four 30-minute bouts of walking at 40-50 percent of the participant's pre-determined aerobic capacity, separated by 5-10 minute breaks. The participants exercise intensity will be monitored continuously using heart rate and activity monitors. Blood glucose and blood ketone levels will be monitored throughout exercise.

Each participant will be assigned to a sequence of the three experimental visits through a randomization process. Each exercise session will be separated by at least two days and participants will be expected to complete all sessions within ~ 12 weeks from the time of the baseline/screening visit. Participants will be instructed to apply a new continuous glucose monitor (CGM) sensor between 1-5 days prior, not to perform moderate-to-vigorous exercise 24 hours prior and refrain from caffeine and alcohol 12 hours prior to each study visit. Participants are also instructed not to eat after 2330h the night before arriving to the laboratory and not to give bolus insulin or perform temporary basal rate changes after 0200h on the morning of the exercise visit. Participants are instructed to try to arrive at the laboratory with their blood glucose between 72-270 mg/dL, with no active bolus insulin according to personal CSII device, in the fasted state. If a bolus of insulin was given prior to the exercise session, the session was rescheduled. Females of reproductive capacity performed all three visits in the early follicular phase (days 1-6 of cycle). Participants arrived at the laboratory between 0600h and 1000h. Exercise start time was between 0700h and 1045h, based on participants' choice, and the timing of exercise was kept consistent within participants.

Following each exercise session, the participant will rest for 20-minutes and then leave the laboratory. The participants glucose will be monitored for 24-hours after the standardized exercise. They will also be instructed to perform a standardized basal insulin reduction overnight to help reduce the risk of post-exercise nocturnal hypoglycemia (-20 percent from bedtime for 6 hours).

Conditions
Type 1 Diabetes
Being tested
Exercise strategies
Keywords
Physical Activity, Exercise, Carbohydrates, Hypoglycemia, Continuous Glucose Monitoring
Medical subject headings
Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise strategiesOther

    Strategies for exercise in type 1 diabetes to maintain glucose control

Study groups in NCT04383015
Study groupRoleWhat they receive
Carbohydrate (CHO)-onlyOtherCarbohydrate dose of 0.3g/kg/hr given every 30 minutes of exercise if blood glucose is in range with usual basal insulin infusion
Receives: Other: Exercise strategies
50 Percent Basal Rate Reduction (BRR)OtherA 50 percent basal rate reduction set 90-minutes pre-exercise and throughout exercise
Receives: Other: Exercise strategies
ComboOtherThe combination of a 50 percent basal rate reduction and carbohydrate dose of 0.3g/kg/hr (given every 30 minutes) both at exercise onset
Receives: Other: Exercise strategies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in glucose target range during exercise intervention

    The primary outcome measurement is to determine which strategy had the best time in blood glucose target range (4.0-10.0 mmol/L) during the prolonged exercise

    Measured: 140 minutes

Secondary outcomes (1)
  1. Recovery Interstitial Glucose

    Using CGM to measure recovery glucose levels post-exercise to analyze time in target range, time in hypoglycemia (< 4.0 mmol/L) and time in hyperglycemia (> 10.0 mmol/L).

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start31 Oct 2018
  3. Primary completion16 Oct 2019
  4. Study completion17 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Patients with type 1 diabetes on insulin pump therapy will remain on their usual insulin regimen. However, we are testing percent basal rate reductions during exercise (50 percent reduction) with or without carbohydrate feeding.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04383015
Sponsor's protocol ID
e2018-306
Status last verified
May 2020
First submitted
6 May 2020
Last updated
11 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise strategies in people with Type 1 Diabetes, run by York University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in glucose target range during exercise intervention (time frame: 140 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.

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