search
Back to results

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
60-hours intervention
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

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%.

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.
  • History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors)
  • Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
  • Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
  • Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
  • Anticholinergic drug (risk of interaction)
  • Pregnancy.
  • 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 or meal contents (gluten free menus will be available).
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. need for major revision of carbohydrate counting).
  • 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).
  • Treatments that could interfere with glucagon

Sites / Locations

  • Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dual-hormone closed-loop strategy

Single-hormone closed-loop strategy

Conventional insulin pump therapy

Arm Description

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

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

In control visit, subjects will use conventional pump therapy to regulate glucose levels.

Outcomes

Primary Outcome Measures

Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range.
Hypoglycemic range is defined to be between below 4 mmol/L

Secondary Outcome Measures

Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range.
Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 8 mmol/L from 22:00 to 7:00.
Percentage of time of glucose levels spent below 3.5 mmol/L
Percentage of time of glucose levels spent below 3.3 mmol/L
Area under the curve of glucose values below 4.0 mmol/L
Area under the curve of glucose values below 3.5 mmol/L
Area under the curve of glucose values below 3.3 mmol/L
Percentage of time of glucose levels spent above 8.0 mmol/L
Percentage of time of glucose levels spent above 10.0 mmol/L
Mean value of glucose levels
Standard deviation of glucose levels
Total insulin delivery
Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading

Full Information

First Posted
October 17, 2013
Last Updated
May 1, 2015
Sponsor
Institut de Recherches Cliniques de Montreal
search

1. Study Identification

Unique Protocol Identification Number
NCT01966393
Brief Title
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults 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 Insulin Pump Therapy in Regulating Glucose Levels During 60 Hours in Free-living Conditions in Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (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
No

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 closed-loop strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes. The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional 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
Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop strategy, Artificial pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual-hormone closed-loop strategy
Arm Type
Active Comparator
Arm Description
In dual-hormone closed-loop strategy, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels
Arm Title
Single-hormone closed-loop strategy
Arm Type
Active Comparator
Arm Description
In single-hormone closed-loop strategy, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
Arm Title
Conventional insulin pump therapy
Arm Type
Active Comparator
Arm Description
In control visit, subjects will use conventional pump therapy to regulate glucose levels.
Intervention Type
Other
Intervention Name(s)
60-hours intervention
Intervention Description
Interventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home.
Primary Outcome Measure Information:
Title
Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range.
Description
Hypoglycemic range is defined to be between below 4 mmol/L
Time Frame
60 hours
Secondary Outcome Measure Information:
Title
Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range.
Description
Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 8 mmol/L from 22:00 to 7:00.
Time Frame
60 hours
Title
Percentage of time of glucose levels spent below 3.5 mmol/L
Time Frame
60 hours
Title
Percentage of time of glucose levels spent below 3.3 mmol/L
Time Frame
60 hours
Title
Area under the curve of glucose values below 4.0 mmol/L
Time Frame
60 hours
Title
Area under the curve of glucose values below 3.5 mmol/L
Time Frame
60 hours
Title
Area under the curve of glucose values below 3.3 mmol/L
Time Frame
60 hours
Title
Percentage of time of glucose levels spent above 8.0 mmol/L
Time Frame
60 hours
Title
Percentage of time of glucose levels spent above 10.0 mmol/L
Time Frame
60 hours
Title
Mean value of glucose levels
Time Frame
60 hours
Title
Standard deviation of glucose levels
Time Frame
60 hours
Title
Total insulin delivery
Time Frame
60 hours
Title
Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading
Time Frame
60 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%. 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. History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors) Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses) Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose) Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding) Anticholinergic drug (risk of interaction) Pregnancy. 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 or meal contents (gluten free menus will be available). Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. need for major revision of carbohydrate counting). 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). Treatments that could interfere with glucagon
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

Learn more about this trial

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes

We'll reach out to this number within 24 hrs