Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes

NCT01930110 | Completed Phase 2

• 1 other identifier: CLASS-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise. The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Hypoglycemia; Insulin; Glucagon; Closed-loop system; Artificial pancreas

Outcome Measures

Primary Outcomes (1)

• The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).

  18:00 hours to 19:30 hours

Secondary Outcomes (8)

• Decrease in glucose levels during each exercise

  18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed

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

  15:30 hours to 19:30 hours

• Percentage of time of plasma glucose levels < 4 mmol/L

  15:30 hours to 19:30 hours

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

  15:30 hours to 19:30 hours

• Decremental area under the curve from the start of the exercise for 90 minutes.

  18:00 to 19:30

Study Arms (2)

Single-hormone closed-loop system

ACTIVE COMPARATOR

In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels

Other: 60-minute exercise; Other: 40-minute interval exercise

Dual-hormone closed-loop system

ACTIVE COMPARATOR

In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels

Other: 60-minute exercise; Other: 40-minute interval exercise

Interventions

60-minute exercise OTHER

Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max. Patients will be discharged at 20:00.

Dual-hormone closed-loop system; Single-hormone closed-loop system

40-minute interval exercise OTHER

Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 40-minute interval exercise. Patients will be discharged at 20:00.

Dual-hormone closed-loop system; Single-hormone closed-loop system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years of old.
• Clinical diagnosis of type 1 diabetes for at least one year.
• The subject will have been on insulin pump therapy for at least 3 months.
• Last (less than 3 months) HbA1c ≤ 12%.

You may not qualify if:

• Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
• Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
• 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 eat snack, not willing to change pump parameters, etc).
• Problems with venous access

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• Société Francophone du Diabète: collaborator

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (1)

• Taleb N, Emami A, Suppere C, Messier V, Legault L, Ladouceur M, Chiasson JL, Haidar A, Rabasa-Lhoret R. Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. Diabetologia. 2016 Dec;59(12):2561-2571. doi: 10.1007/s00125-016-4107-0. Epub 2016 Oct 4.

  PMID: 27704167 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rémi Rabasa-Lhoret, MD, PhD

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Medicine

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 28, 2013
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 4, 2015

Record last verified: 2015-05

Locations

CA (1)