Closed-loop Control of Glucose Levels in the Context of Exercise in Adults With Type-1 Diabetes (CLASS-01)

Institut de Recherches Cliniques de Montreal

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 1 Diabetes

Treatments: Device: Conventional continuous subcutaneous insulin infusion therapy; Device: Dual-hormone closed-loop

Study type: Interventional

Funder types: Other

Identifiers

NCT01297946

CLASS-01

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups, including a placebo group

Open-loop

Placebo Comparator group

Description:

Conventional continuous subcutaneous insulin infusion (CSII) therapy

Treatment:

Device: Conventional continuous subcutaneous insulin infusion therapy

Dual-hormone closed-loop

Experimental group

Description:

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.

Treatment:

Device: Dual-hormone closed-loop