NCT03349489

Brief Summary

It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. The objective of this study will be to compare the efficacy of two strategies to prevent exercise-induced hypoglycemia during a 60-minute exercise at moderate intensity: 1) reduce insulin basal rate 40 minutes prior to exercise; 2) reduce insulin basal rate 90 minutes prior to exercise.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

November 17, 2017

Last Update Submit

May 18, 2018

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 diabetesExerciseHypoglycemiaInsulin pump

Outcome Measures

Primary Outcomes (1)

  • Decrease in glucose levels

    Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise

    60 minutes (exercise period)

Secondary Outcomes (26)

  • Percentage of time of glucose levels spent below 4 mmol/L

    60 minutes (exercise period)

  • Decremental area under the curve of glucose levels

    60 minutes (exercise period)

  • Area under the curve of glucose levels < 4 mmol/L

    60 minutes (exercise period)

  • Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L

    60 minutes (exercise period)

  • Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L

    60 minutes (exercise period)

  • +21 more secondary outcomes

Study Arms (2)

Reduction of insulin basal rate 40 minutes prior to exercise

ACTIVE COMPARATOR
Other: Exercise 2Device: Dexcom G4 PlatinumDrug: InsulinDevice: Insulin pump

Reduction of insulin basal rate 90 minutes prior to exercise

ACTIVE COMPARATOR
Other: Exercise 1Device: Dexcom G4 PlatinumDrug: InsulinDevice: Insulin pump

Interventions

Exercise 1OTHER

Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.

Reduction of insulin basal rate 90 minutes prior to exercise
Exercise 2OTHER

Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.

Reduction of insulin basal rate 40 minutes prior to exercise
Dexcom G4 PlatinumDEVICE

The Dexcom G4 Platinum will be used to measure continuous glucose levels.

Reduction of insulin basal rate 40 minutes prior to exerciseReduction of insulin basal rate 90 minutes prior to exercise
InsulinDRUG

Participant's usual fast-acting insulin analog will be used.

Reduction of insulin basal rate 40 minutes prior to exerciseReduction of insulin basal rate 90 minutes prior to exercise
Insulin pumpDEVICE

Participant's insulin pump will be used to infuse insulin.

Reduction of insulin basal rate 40 minutes prior to exerciseReduction of insulin basal rate 90 minutes prior to exercise

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females ≥ 14 years of old.
  • Clinical diagnosis of type 1 diabetes for at least two years.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • Last (less than 2 months) HbA1c ≤ 10%.

You may not qualify if:

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
  • Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Abnormal blood panel and/or anemia.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
  • Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (1)

  • Tagougui S, Legault L, Heyman E, Messier V, Suppere C, Potter KJ, Pigny P, Berthoin S, Taleb N, Rabasa-Lhoret R. Anticipated Basal Insulin Reduction to Prevent Exercise-Induced Hypoglycemia in Adults and Adolescents Living with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):307-315. doi: 10.1089/dia.2021.0375. Epub 2022 Apr 27.

    PMID: 35099281DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor ActivityHypoglycemia

Interventions

InsulinInsulin Infusion Systems

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDrug Delivery SystemsDrug TherapyTherapeuticsInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment

Study Officials

  • Laurent Legault

    Montreal Children's Hospital of the MUHC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Semah Tagougui

CONTACT

514-987-5500semah.tagougui@ircm.qc.ca

Virginie Messier

CONTACT

514-987-5500virginie.messier@ircm.qc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCP

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

May 18, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

CA(2)