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Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
14 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 system, Artificial pancreas, Carbohydrate counting

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.
  • Last (less than 3 months) HbA1c ≤ 12%.

Exclusion Criteria:

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Medication likely to affect with the interpretation of the results because of their well known impact on gastric emptying: Motilium®, Prandase®, Victoza®, Byetta® and Symlin®.
  • Known or suspected allergy to the trial products, meal contents including nuts, peanuts, dairy products or eggs.
  • Unusual nutritional habits (e.g. vegetarians)
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
  • Unreliable carbohydrate counting or lack of insulin to carbohydrate ratios
  • Problems with venous access

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

CHO-dependant bolus

CHO-independent bolus

Conventional treatment

Arm Description

An insulin bolus dependant of carbohydrate content will be given after each meal. Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.

An insulin bolus independent of carbohydrate content will be given after each meal. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.

Patients will use conventional pump therapy to regulate glucose levels

Outcomes

Primary Outcome Measures

The positive incremental area under the curve of postprandial glucose excursions
The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.

Secondary Outcome Measures

Mean plasma glucose
Incremental two hours postprandial glucose
Incremental postprandial peak-glucose values
Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Total insulin delivery
Total glucagon delivery
Standard deviation of glucose levels
Percentage of time of plasma glucose concentrations below 3.5 mmol/L
Percentage of time of plasma glucose concentrations above 14 mmol/L
Mean plasma insulin concentration
Mean plasma glucagon concentration
Number of patients experiencing hypoglycemia requiring oral treatment
Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L.

Full Information

First Posted
August 23, 2013
Last Updated
April 8, 2014
Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01930097
Brief Title
Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes
Official Title
An Open-label, Randomized, Three-way, Cross-over Study to Compare the Efficacy of Closed-loop Operation Combined With Meal-and-carbohydrate-announcement Closed-loop Operation Combined With Meal-announcement, and Conventional Pump Therapy in Regulating Glucose Levels in Adults With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
Juvenile Diabetes Research Foundation

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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The objective of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control. Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.
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. Each patient will be admitted three times to a clinical research facility. In the meal-and-carbohydrate-announcement visit, patients will eat 3 meals accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the meal-announcement visit, patients will eat the 3 same meals but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. In the control visit, patients will use conventional pump therapy to regulate glucose levels.

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, Carbohydrate counting

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CHO-dependant bolus
Arm Type
Active Comparator
Arm Description
An insulin bolus dependant of carbohydrate content will be given after each meal. Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
Arm Title
CHO-independent bolus
Arm Type
Active Comparator
Arm Description
An insulin bolus independent of carbohydrate content will be given after each meal. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
Patients will use conventional pump therapy to regulate glucose levels
Intervention Type
Other
Intervention Name(s)
14 hours intervention
Intervention Description
Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
Primary Outcome Measure Information:
Title
The positive incremental area under the curve of postprandial glucose excursions
Description
The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.
Time Frame
4 hours after meal intake
Secondary Outcome Measure Information:
Title
Mean plasma glucose
Time Frame
8h00 to 21h00
Title
Incremental two hours postprandial glucose
Time Frame
2 hours after meal intake
Title
Incremental postprandial peak-glucose values
Time Frame
8h00 to 21h00
Title
Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L
Time Frame
8h00 to 21h00
Title
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Time Frame
8h00 to 21h00
Title
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Time Frame
8h00 to 21h00
Title
Total insulin delivery
Time Frame
8h00 to 21h00
Title
Total glucagon delivery
Time Frame
8h00 to 21h00
Title
Standard deviation of glucose levels
Time Frame
8h00 to 21h00
Title
Percentage of time of plasma glucose concentrations below 3.5 mmol/L
Time Frame
8h00 to 21h00
Title
Percentage of time of plasma glucose concentrations above 14 mmol/L
Time Frame
8h00 to 21h00
Title
Mean plasma insulin concentration
Time Frame
8h00 to 21h00
Title
Mean plasma glucagon concentration
Time Frame
8h00 to 21h00
Title
Number of patients experiencing hypoglycemia requiring oral treatment
Time Frame
8h00 to 21h00
Title
Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L.
Time Frame
4 hours after meal intake

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. Last (less than 3 months) HbA1c ≤ 12%. Exclusion Criteria: Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. Ongoing pregnancy. Severe hypoglycemic episode within two weeks of screening. Medication likely to affect with the interpretation of the results because of their well known impact on gastric emptying: Motilium®, Prandase®, Victoza®, Byetta® and Symlin®. Known or suspected allergy to the trial products, meal contents including nuts, peanuts, dairy products or eggs. Unusual nutritional habits (e.g. vegetarians) Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc). Unreliable carbohydrate counting or lack of insulin to carbohydrate ratios Problems with venous access
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
H2W1R7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26072052
Citation
Gingras V, Rabasa-Lhoret R, Messier V, Ladouceur M, Legault L, Haidar A. Efficacy of dual-hormone artificial pancreas to alleviate the carbohydrate-counting burden of type 1 diabetes: A randomized crossover trial. Diabetes Metab. 2016 Feb;42(1):47-54. doi: 10.1016/j.diabet.2015.05.001. Epub 2015 Jun 10.
Results Reference
derived

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Closed-loop Control of Glucose Levels After Meal Intake in Adults With Type 1 Diabetes

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