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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Conventional continuous subcutaneous insulin infusion therapy

Dual-hormone closed-loop

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Institut de Recherches Cliniques de Montréal (IRCM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Open-loop

Dual-hormone closed-loop

Arm Description

Conventional continuous subcutaneous insulin infusion (CSII) therapy

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.

Outcomes

Primary Outcome Measures

Percentage of time of plasma glucose concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.)

Secondary Outcome Measures

Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l).

Percentage of time of plasma glucose concentrations spent in the high range (>10.0 mmol/l from 4:00p.m.-11:00 p.m. and >8.0 mmol/l from 11:00 p.m.-7:00 a.m.).

Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l).

Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l).

Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l).

Total insulin delivery.

Total overnight insulin delivery (11 p.m. - 7 a.m.).

Standard deviation and/or MAGE (Mean Amplitude of Glycemic Excursions) index of plasma glucose concentrations as measures of glucose variability.

Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l.

Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l.

Number of subjects with at least one exercise-induced plasma glucose measurement less than 3.9 mmol/l.

Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l.

Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l.

Number of subjects with at least one exercise-induced plasma glucose measurement below 3.3 mmol/l.

Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l.

Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l.

Number of subjects with at least one exercise-induced plasma glucose measurement below 3.0 mmol/l.

Full Information

NCT ID

NCT01297946

First Posted

February 15, 2011

Last Updated

April 20, 2012

Sponsor

Institut de Recherches Cliniques de Montreal

Collaborators

McGill University, Montreal Children's Hospital of the MUHC, Diabetes Québec, Medtronic Minimed

1. Study Identification

Unique Protocol Identification Number

NCT01297946

Brief Title

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

Acronym

CLASS-01

Official Title

An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Dual-hormone Closed-loop Strategy as Compared to Conventional CSII Therapy in Regulating Glucose Levels in Adults With Type-1 Diabetes in the Context of Exercise

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Institut de Recherches Cliniques de Montreal

Collaborators

McGill University, Montreal Children's Hospital of the MUHC, Diabetes Québec, Medtronic Minimed

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open-loop

Arm Type

Placebo Comparator

Arm Description

Conventional continuous subcutaneous insulin infusion (CSII) therapy

Arm Title

Dual-hormone closed-loop

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Conventional continuous subcutaneous insulin infusion therapy

Intervention Type

Device

Intervention Name(s)

Dual-hormone closed-loop

Primary Outcome Measure Information:

Title

Percentage of time of plasma glucose concentrations spent in target range (4.0-10.0 mmol/l from 4:00p.m.-11:00p.m. and 4.0-8.0 mmol/l from 11:00p.m.-7:00a.m.)

Time Frame

4 p.m. - 7 a.m.

Secondary Outcome Measure Information:

Title

Percentage of time of plasma glucose concentrations spent in the low range (< 4.0 mmol/l).

Time Frame

4 p.m. - 7 a.m.

Title

Percentage of time of plasma glucose concentrations spent in the high range (>10.0 mmol/l from 4:00p.m.-11:00 p.m. and >8.0 mmol/l from 11:00 p.m.-7:00 a.m.).

Time Frame

4 p.m. - 7 a.m

Title

Percentage of overnight time of plasma glucose concentrations spent in target range (4.0 - 8.0 mmol/l).

Time Frame

11 p.m. - 7 a.m.

Title

Percentage of overnight time of plasma glucose concentrations spent in the low range ( < 4.0 mmol/l).

Time Frame

11 p.m. - 7 a.m.

Title

Percentage of overnight time of plasma glucose concentrations spent in the high range (above 8 mmol/l).

Time Frame

11 p.m. - 7 a.m.

Title

Total insulin delivery.

Time Frame

4 p.m. - 7 a.m.

Title

Total overnight insulin delivery (11 p.m. - 7 a.m.).

Time Frame

11 p.m. - 7 a.m.

Title

Standard deviation and/or MAGE (Mean Amplitude of Glycemic Excursions) index of plasma glucose concentrations as measures of glucose variability.

Time Frame

4 p.m. - 7 a.m.

Title

Number of subjects with at least one plasma glucose measurement less than 3.9 mmol/l.

Time Frame

4 p.m. - 7 a.m.

Title

Number of subjects with at least one overnight plasma glucose measurement less than 3.9 mmol/l.

Time Frame

11 p.m. - 7 a.m

Title

Number of subjects with at least one exercise-induced plasma glucose measurement less than 3.9 mmol/l.

Time Frame

5:50 p.m. - 7:20 p.m

Title

Number of subjects with as at least one plasma glucose measurement below 3.3 mmol/l.

Time Frame

4 p.m. - 7 a.m.

Title

Number of subjects with at least one overnight plasma glucose measurement below 3.3 mmol/l.

Time Frame

11 p.m. - 7 a.m

Title

Number of subjects with at least one exercise-induced plasma glucose measurement below 3.3 mmol/l.

Time Frame

5:50 p.m. - 7:20 p.m

Title

Number of subjects with as at least one plasma glucose measurement below 3.0 mmol/l.

Time Frame

4 p.m. - 7 a.m.

Title

Number of subjects with at least one overnight plasma glucose measurement below 3.0 mmol/l.

Time Frame

11 p.m. - 7 a.m

Title

Number of subjects with at least one exercise-induced plasma glucose measurement below 3.0 mmol/l.

Time Frame

5:50 p.m. - 7:20 p.m

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rémi Rabasa-Lhoret, M.D., Ph.D.

Organizational Affiliation

Institut de Recherches Cliniques de Montréal (IRCM)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Recherches Cliniques de Montréal (IRCM)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1R7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

32345707

Citation

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.

Results Reference

derived

PubMed Identifier

23359039

Citation

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.

Results Reference

derived

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

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