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Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Overnight intervention

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Hypoglycemia unawareness, Nocturnal hypoglycemia, Closed-loop strategy, Artificial pancreas, Glucagon, 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 ≤ 12%.
Hypoglycemia awareness or unawareness assessed by a questionnaire.
Documented NH during the run-in period.

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.
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 snack 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 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 Type

Active Comparator

Arm Label

Single-hormone closed-loop strategy

Dual-hormone closed-loop strategy

Arm Description

Outcomes

Primary Outcome Measures

Percentage of time of plasma glucose levels spent below 4 mmol/L

Secondary Outcome Measures

Percentage of time of plasma glucose levels spent between 4 and 8 mmol/L

Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L

Percentage of time of plasma glucose levels spent below 3.5 mmol/L

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

Percentage of time of plasma glucose levels spent above 8 mmol/L

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

Area under the curve of plasma glucose levels spent below 4 mmol/L

Area under the curve of plasma glucose levels spent below 3.5 mmol/L

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

Area under the curve of plasma glucose levels spent above 8 mmol/L

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

Mean plasma glucose levels

Standard deviation of plasma glucose levels

Total insulin delivery

Total glucagon delivery

Number of subjects experiencing at least one hypoglycemic event requiring oral treatment

Total number of hypoglycemic events requiring treatment

Full Information

NCT ID

NCT02282254

First Posted

October 19, 2014

Last Updated

November 8, 2016

Sponsor

Institut de Recherches Cliniques de Montreal

1. Study Identification

Unique Protocol Identification Number

NCT02282254

Brief Title

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

Official Title

An Open-label, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone and Dual-hormone Closed-loop Strategy in Regulating Overnight Glucose Levels in Type 1 diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institut de Recherches Cliniques de Montreal

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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal hypoglycemia. The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels compared to single-hormone closed-loop strategy.

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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The investigators aim to conduct the 1st randomized cross-over trial comparing single- hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels. The investigators aim to compare the two interventions for 10 hours in two subgroups of adults with type 1 diabètes. Patients from both subgroups will present documented nocturnal hypoglycemia. One subgroup will consist of patients with hypoglycemia unawareness while the other subgroup will consist of patients with hypoglycemia unawareness. This study will allow to determine if there is a greater benefit of a closed-loop strategy in a higher-risk hypoglycemia unaware group.

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 unawareness, Nocturnal hypoglycemia, Closed-loop strategy, Artificial pancreas, Glucagon, Hypoglycemia, Insulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-hormone closed-loop strategy

Arm Type

Active Comparator

Arm Title

Dual-hormone closed-loop strategy

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Overnight intervention

Intervention Description

Subjects will be admitted at the research facility at 19:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed. At 20:30, a snack containing 20g of carbohydrate will be given. Closed-loop strategy will start at 20:00 until 7:00 next morning. A glucose sensor reading will be entered manually in a tablet every 10 minutes. The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits). Pumps' parameters will then be changed manually to implement the tablet generated recommendations.

Primary Outcome Measure Information:

Title

Percentage of time of plasma glucose levels spent below 4 mmol/L

Time Frame

Up to 8 hours

Secondary Outcome Measure Information:

Title

Percentage of time of plasma glucose levels spent between 4 and 8 mmol/L

Time Frame

Up to 8 hours

Title

Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L

Time Frame

Up to 8 hours

Title

Percentage of time of plasma glucose levels spent below 3.5 mmol/L

Time Frame

Up to 8 hours

Title

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

Time Frame

Up to 8 hours

Title

Percentage of time of plasma glucose levels spent above 8 mmol/L

Time Frame

Up to 8 hours

Title

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

Time Frame

Up to 8 hours

Title

Area under the curve of plasma glucose levels spent below 4 mmol/L

Time Frame

Up to 8 hours

Title

Area under the curve of plasma glucose levels spent below 3.5 mmol/L

Time Frame

Up to 8 hours

Title

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

Time Frame

Up to 8 hours

Title

Area under the curve of plasma glucose levels spent above 8 mmol/L

Time Frame

Up to 8 hours

Title

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

Time Frame

Up to 8 hours

Title

Mean plasma glucose levels

Time Frame

Up to 8 hours

Title

Standard deviation of plasma glucose levels

Time Frame

Up to 8 hours

Title

Total insulin delivery

Time Frame

Up to 8 hours

Title

Total glucagon delivery

Time Frame

Up to 8 hours

Title

Number of subjects experiencing at least one hypoglycemic event requiring oral treatment

Time Frame

Up to 8 hours

Title

Total number of hypoglycemic events requiring treatment

Time Frame

Up to 8 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 ≤ 12%. Hypoglycemia awareness or unawareness assessed by a questionnaire. Documented NH during the run-in period. 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. 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 snack 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 snacks, not willing to change pump parameters, etc).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Remi Rabasa-Lhoret

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

29393675

Citation

Abitbol A, Rabasa-Lhoret R, Messier V, Legault L, Smaoui M, Cohen N, Haidar A. Overnight Glucose Control with Dual- and Single-Hormone Artificial Pancreas in Type 1 Diabetes with Hypoglycemia Unawareness: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Mar;20(3):189-196. doi: 10.1089/dia.2017.0353. Epub 2018 Feb 2.

Results Reference

derived

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Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

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