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Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults and Adolescents With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Closed-loop system

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and females ≥ 12 years of old.
Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
The subject will have been on insulin pump therapy for at least 3 months.
HbA1c ≤ 12%.

Exclusion Criteria:

Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
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 (except low stable dose).
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 meals/snacks, not willing to change pump parameters, etc).

Sites / Locations

Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Single-hormone closed-loop system

Dual-hormone closed-loop system

Insulin pump therapy

Arm Description

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

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

Patient's conventional treatment will be implemented.

Outcomes

Primary Outcome Measures

Percentage of time of plasma glucose levels spent in target range.

Two-hour postprandial target range is between 4.0 and 10.0 mmol/l. Otherwise, target range is defined to be between 4.0 and 8.0 mmol/l.

Secondary Outcome Measures

Percentage of time of plasma glucose levels spent in the low range

Low range is defined to be a. below 4 mmol/L; b. below 3.5 mmol/L; c. below 3.3 mmol/L.

Percentage of overnight time of plasma glucose levels spent in the low range

Low range is defined to be a. < 4 mmol/L; b. < 3.5 mmol/L; c. < 3.3 mmol/L.

Standard deviation of glucose levels

Measure of glucose variability

Total insulin delivery

Mean plasma glucose level

Mean plasma insulin concentration

Mean plasma glucagon concentration

Number of subjects experiencing hypoglycemia requiring oral treatment

Number of subjects experiencing hypoglycemia requiring oral treatment during a. the overall study period; b. the exercise; c. the night.

Percentage of time of plasma glucose levels spent between 4.0 and 10.0 mmol/L

Percentage of overnight time of plasma glucose levels spent between 4.0 and 8.0 mmol/L

Percentage of overnight time of plasma glucose levels spent between 4.0 and 10.0 mmol/L

Percentage of time of plasma glucose levels spent in the high range

High range is defined to be above a. 8.0 mmol/L; b. 10.0 mmol/L

Percentage of overnight time of plasma glucose levels spent in the high range

High range is defined to be above a. 8.0 mmol/L; b. 10.0 mmol/L.

Full Information

NCT ID

NCT01754337

First Posted

December 13, 2012

Last Updated

July 3, 2014

Sponsor

Institut de Recherches Cliniques de Montreal

Collaborators

McGill University, Montreal Children's Hospital of the MUHC

1. Study Identification

Unique Protocol Identification Number

NCT01754337

Brief Title

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults and Adolescents With Type 1 Diabetes

Official Title

An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Glucose Levels During 24 Hours in Adults and Adolescents With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institut de Recherches Cliniques de Montreal

Collaborators

McGill University, Montreal Children's Hospital of the MUHC

4. Oversight

Data Monitoring Committee

5. Study Description

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 hormone: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a 24-hours in-patient study with standardized conditions in adults and adolescents with type 1 diabetes. The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.

Detailed Description

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 hormone: insulin and glucagon. We aim to conduct the 1st randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. We aim to compare the three interventions for 24 hours in adults and adolescents with type 1 diabetes. Each 24 hours will include a 60-min exercise session, three meals characterizing a full day, activities that mimick real-life conditions and an overnight stay. This study will also allow for multiple comparisons and evaluating the benefits of each component separately (i.e. the benefits of merely closing the loop with insulin alone vs. adding glucagon to the closed-loop strategy).

6. Conditions and Keywords

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

Type 1 Diabetes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single-hormone closed-loop system

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dual-hormone closed-loop system

Arm Type

Active Comparator

Arm Description

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

Arm Title

Insulin pump therapy

Arm Type

Active Comparator

Arm Description

Patient's conventional treatment will be implemented.

Intervention Type

Other

Intervention Name(s)

Closed-loop system

Intervention Description

Patients will be admitted at the research clinical facility at 7:00. At 8:00, a mixed meal will be served. At 9:00, patients will be asked to perform two 30-min standardized activities. At 12:00, a mixed meal will be served. At 13:00, patients will be asked to perform two 30-min activities. At 17:00, a mixed meal will be served. At 19:30, patients will perform 60 minutes of aerobic treadmill exercise at an intensity of 60% VO2max. A bedtime snack of 20g carbohydrate will be given at 21:00. Patients will be discharged at 8:00 the next morning

Primary Outcome Measure Information:

Title

Percentage of time of plasma glucose levels spent in target range.

Description

Two-hour postprandial target range is between 4.0 and 10.0 mmol/l. Otherwise, target range is defined to be between 4.0 and 8.0 mmol/l.

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Percentage of time of plasma glucose levels spent in the low range

Description

Low range is defined to be a. below 4 mmol/L; b. below 3.5 mmol/L; c. below 3.3 mmol/L.

Time Frame

24 hours

Title

Percentage of overnight time of plasma glucose levels spent in the low range

Description

Low range is defined to be a. < 4 mmol/L; b. < 3.5 mmol/L; c. < 3.3 mmol/L.

Time Frame

9 hours

Title

Standard deviation of glucose levels

Description

Measure of glucose variability

Time Frame

24 hours

Title

Total insulin delivery

Time Frame

24 hours

Title

Mean plasma glucose level

Time Frame

24 hours

Title

Mean plasma glucose level

Time Frame

9 hours

Title

Mean plasma insulin concentration

Time Frame

24 hours

Title

Mean plasma glucagon concentration

Time Frame

24 hours

Title

Number of subjects experiencing hypoglycemia requiring oral treatment

Description

Number of subjects experiencing hypoglycemia requiring oral treatment during a. the overall study period; b. the exercise; c. the night.

Time Frame

24 hours

Title

Percentage of time of plasma glucose levels spent between 4.0 and 10.0 mmol/L

Time Frame

24 hours

Title

Percentage of overnight time of plasma glucose levels spent between 4.0 and 8.0 mmol/L

Time Frame

9 hours

Title

Percentage of overnight time of plasma glucose levels spent between 4.0 and 10.0 mmol/L

Time Frame

9 hours

Title

Percentage of time of plasma glucose levels spent in the high range

Description

High range is defined to be above a. 8.0 mmol/L; b. 10.0 mmol/L

Time Frame

24 hours

Title

Percentage of overnight time of plasma glucose levels spent in the high range

Description

High range is defined to be above a. 8.0 mmol/L; b. 10.0 mmol/L.

Time Frame

9 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females ≥ 12 years of old. Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed. The subject will have been on insulin pump therapy for at least 3 months. HbA1c ≤ 12%. Exclusion Criteria: Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. 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 (except low stable dose). 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 meals/snacks, not willing to change pump parameters, etc).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rémi Rabasa-Lhoret, MD, PhD

Organizational Affiliation

Institut de recherches cliniques de Montréal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de recherches cliniques de Montréal

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1R7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25434967

Citation

Haidar A, Legault L, Messier V, Mitre TM, Leroux C, Rabasa-Lhoret R. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open-label randomised controlled crossover trial. Lancet Diabetes Endocrinol. 2015 Jan;3(1):17-26. doi: 10.1016/S2213-8587(14)70226-8. Epub 2014 Nov 27.

Results Reference

derived

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Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults and Adolescents With Type 1 Diabetes

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