Closed-loop Control of Glucose Levels in the Context of Exercise in Adults With Type-1 Diabetes

NCT ID: NCT01297946

Last Updated: 2012-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL

Brief Summary

Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward closed-loop strategies to regulate glucose levels in patients with type 1 diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer-generated recommendation that relies on continuous glucose sensor readings. In this study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII) therapy in regulating glucose levels during an evening exercise and on a night following an exercise in adults with type 1 diabetes.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-loop

Conventional continuous subcutaneous insulin infusion (CSII) therapy

Group Type: PLACEBO_COMPARATOR

Conventional continuous subcutaneous insulin infusion therapy

Intervention Type: DEVICE

Dual-hormone closed-loop

Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. The infusion rates are based on continuous glucose sensor reading and a control algorithm.

Group Type: EXPERIMENTAL

Dual-hormone closed-loop

Intervention Type: DEVICE

Interventions

Conventional continuous subcutaneous insulin infusion therapy

Intervention Type: DEVICE

Dual-hormone closed-loop

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of type 1 diabetes for at least one year.
• On insulin pump therapy for at least 3 months.
• HbA1c ≤ 10%.

Exclusion Criteria

• Clinically significant nephropathy, neuropathy or retinopathy.
• Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
• A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
• Pregnancy.
• Severe hypoglycemic episode within two weeks of screening.
• Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
• Known or suspected allergy to the trial products or meal contents.
• Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
• Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
• Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

Montreal Children's Hospital of the MUHC

OTHER

Sponsor Role: collaborator

Diabetes Québec

OTHER

Sponsor Role: collaborator

Medtronic Minimed

UNKNOWN

Sponsor Role: collaborator

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Institut de Recherches Cliniques de Montreal

Principal Investigators

Rémi Rabasa-Lhoret, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institut de Recherches Cliniques de Montréal (IRCM)

Locations

Institut de Recherches Cliniques de Montréal (IRCM)

Montreal, Quebec, Canada

Countries

Canada

References

Heyland DK, Heyland R, Bailey A, Howard M. A novel decision aid to help plan for serious illness: a multisite randomized trial. CMAJ Open. 2020 Apr 28;8(2):E289-E296. doi: 10.9778/cmajo.20190179. Print 2020 Apr-Jun.

Reference Type: DERIVED

PMID: 32345707 (View on PubMed)

Haidar A, Legault L, Dallaire M, Alkhateeb A, Coriati A, Messier V, Cheng P, Millette M, Boulet B, Rabasa-Lhoret R. Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ. 2013 Mar 5;185(4):297-305. doi: 10.1503/cmaj.121265. Epub 2013 Jan 28.

Reference Type: DERIVED

PMID: 23359039 (View on PubMed)

Other Identifiers

CLASS-01

Identifier Type: -

Identifier Source: org_study_id