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Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status

Withdrawn

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

5-day intervention with single-hormone closed-loop strategy

5-day intervention with sensor-augmented pump therapy

Insulin pump

Continuous glucose monitoring system

Insulin

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

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.
HbA1c ≤ 10%.
Live in the area of Montreal.

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.
Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
Pregnancy (ongoing or current attempt to become pregnant).
Severe hypoglycemic episode within two weeks of screening.
Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
Known or suspected allergy to the trial products
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).

Sites / Locations

Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Sensor-augmented pump therapy

Single-hormone closed-loop strategy

Arm Description

Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.

Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.

Outcomes

Primary Outcome Measures

Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L

Secondary Outcome Measures

Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

Percentage of time of glucose levels spent below 3.9 mmol/L

Percentage of time of glucose levels spent below 3.3 mmol/L

Percentage of time of glucose levels spent below 2.8 mmol/L

Percentage of time of glucose levels spent above 10 mmol/L

Percentage of time of glucose levels spent above 13.9 mmol/L

Percentage of time of glucose levels spent above 16.7 mmol/L

Percentage of time of overnight glucose levels spent below 3.9 mmol/L

Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L

Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L

Percentage of time of overnight glucose levels spent below 3.3 mmol/L

Percentage of time of overnight glucose levels spent below 2.8 mmol/L

Percentage of time of overnight glucose levels spent above 10 mmol/L

Percentage of time of overnight glucose levels spent above 13.9 mmol/L

Percentage of time of overnight glucose levels spent above 16.7 mmol/L

Area under the curve of glucose levels below 3.9 mmol/L

Area under the curve of glucose levels below 3.3 mmol/L

Area under the curve of glucose levels below 2.8 mmol/L

Area under the curve of glucose levels above 10 mmol/L

Area under the curve of glucose levels above 13.9 mmol/L

Area under the curve of glucose levels above 16.7 mmol/L

Area under the curve of overnight glucose levels below 3.9 mmol/L

Area under the curve of overnight glucose levels below 3.3 mmol/L

Area under the curve of overnight glucose levels below 2.8 mmol/L

Area under the curve of overnight glucose levels above 10 mmol/L

Area under the curve of overnight glucose levels above 13.9 mmol/L

Area under the curve of overnight glucose levels above 16.7 mmol/L

Mean glucose levels

Standard deviation of glucose levels

Standard deviation of insulin delivery

Coefficient of variance of glucose levels

Coefficient of variance of insulin delivery

Between-day variability in glucose levels

Between-day variability in insulin delivery

Total insulin delivery

Percentage of time of closed-loop operation

Percentage of time of glucose sensor availability

Time between failures

Total hours of closed-loop operation over number of failures

Number of hypoglycemic events less than 3.1 mmol/L

Number of nights with hypoglycemic events less than 3.1 mmol/L

Number of days with hypoglycemic events less than 3.1 mmol/L

Full Information

NCT ID

NCT02488616

First Posted

June 26, 2015

Last Updated

January 29, 2018

Sponsor

Institut de Recherches Cliniques de Montreal

1. Study Identification

Unique Protocol Identification Number

NCT02488616

Brief Title

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

Official Title

An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy and Sensor-augmented Pump Therapy in Regulating Glucose Levels for 5 Days in Free-living Outpatient Conditions in Patients With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Medtronic support terminated

Study Start Date

March 2018 (Anticipated)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institut de Recherches Cliniques de Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes. The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.

6. Conditions and Keywords

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

Type 1 Diabetes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sensor-augmented pump therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Single-hormone closed-loop strategy

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

5-day intervention with single-hormone closed-loop strategy

Intervention Description

A sensor will be inserted on the day prior to the first day of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 5 days.

Intervention Type

Other

Intervention Name(s)

5-day intervention with sensor-augmented pump therapy

Intervention Description

A sensor will be inserted on the day prior to the first day of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 5 days. Participants will have been previously shown how to use the study insulin pump.

Intervention Type

Device

Intervention Name(s)

Insulin pump

Intervention Description

MiniMed® Paradigm® Veo™, Medtronic

Intervention Type

Device

Intervention Name(s)

Continuous glucose monitoring system

Intervention Description

Enlite sensor®, Medtronic

Intervention Type

Drug

Intervention Name(s)

Insulin

Intervention Description

Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)

Primary Outcome Measure Information:

Title

Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L

Time Frame

120 hours

Secondary Outcome Measure Information:

Title

Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L

Time Frame

120 hours

Title

Percentage of time of glucose levels spent below 3.9 mmol/L

Time Frame

120 hours

Title

Percentage of time of glucose levels spent below 3.3 mmol/L

Time Frame

120 hours

Title

Percentage of time of glucose levels spent below 2.8 mmol/L

Time Frame

120 hours

Title

Percentage of time of glucose levels spent above 10 mmol/L

Time Frame

120 hours

Title

Percentage of time of glucose levels spent above 13.9 mmol/L

Time Frame

120 hours

Title

Percentage of time of glucose levels spent above 16.7 mmol/L

Time Frame

120 hours

Title

Percentage of time of overnight glucose levels spent below 3.9 mmol/L

Time Frame

35 hours

Title

Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L

Time Frame

35 hours

Title

Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L

Time Frame

35 hours

Title

Percentage of time of overnight glucose levels spent below 3.3 mmol/L

Time Frame

35 hours

Title

Percentage of time of overnight glucose levels spent below 2.8 mmol/L

Time Frame

35 hours

Title

Percentage of time of overnight glucose levels spent above 10 mmol/L

Time Frame

35 hours

Title

Percentage of time of overnight glucose levels spent above 13.9 mmol/L

Time Frame

35 hours

Title

Percentage of time of overnight glucose levels spent above 16.7 mmol/L

Time Frame

35 hours

Title

Area under the curve of glucose levels below 3.9 mmol/L

Time Frame

120 hours

Title

Area under the curve of glucose levels below 3.3 mmol/L

Time Frame

120 hours

Title

Area under the curve of glucose levels below 2.8 mmol/L

Time Frame

120 hours

Title

Area under the curve of glucose levels above 10 mmol/L

Time Frame

120 hours

Title

Area under the curve of glucose levels above 13.9 mmol/L

Time Frame

120 hours

Title

Area under the curve of glucose levels above 16.7 mmol/L

Time Frame

120 hours

Title

Area under the curve of overnight glucose levels below 3.9 mmol/L

Time Frame

35 hours

Title

Area under the curve of overnight glucose levels below 3.3 mmol/L

Time Frame

35 hours

Title

Area under the curve of overnight glucose levels below 2.8 mmol/L

Time Frame

35 hours

Title

Area under the curve of overnight glucose levels above 10 mmol/L

Time Frame

35 hours

Title

Area under the curve of overnight glucose levels above 13.9 mmol/L

Time Frame

35 hours

Title

Area under the curve of overnight glucose levels above 16.7 mmol/L

Time Frame

35 hours

Title

Mean glucose levels

Time Frame

120 hours

Title

Standard deviation of glucose levels

Time Frame

120 hours

Title

Standard deviation of insulin delivery

Time Frame

120 hours

Title

Coefficient of variance of glucose levels

Time Frame

120 hours

Title

Coefficient of variance of insulin delivery

Time Frame

120 hours

Title

Between-day variability in glucose levels

Time Frame

120 hours

Title

Between-day variability in insulin delivery

Time Frame

120 hours

Title

Total insulin delivery

Time Frame

120 hours

Title

Percentage of time of closed-loop operation

Time Frame

120 hours

Title

Percentage of time of glucose sensor availability

Time Frame

120 hours

Title

Time between failures

Description

Total hours of closed-loop operation over number of failures

Time Frame

120 hours

Title

Number of hypoglycemic events less than 3.1 mmol/L

Time Frame

120 hours

Title

Number of nights with hypoglycemic events less than 3.1 mmol/L

Time Frame

35 hours

Title

Number of days with hypoglycemic events less than 3.1 mmol/L

Time Frame

120 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. HbA1c ≤ 10%. Live in the area of Montreal. 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. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding) Pregnancy (ongoing or current attempt to become pregnant). Severe hypoglycemic episode within two weeks of screening. Current use of glucocorticoid medication (except low stable dose and inhaled steroids). Known or suspected allergy to the trial products 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).

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

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Closed-loop Control of Glucose Levels (Artificial Pancreas) for 5 Days in Adults With Type 1 Diabetes

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