Back to resultsClosed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Patient's insulin pump
Insulin
Dexcom G4 Platinum glucose sensor
Single-hormone closed-loop
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Closed-loop system, Artificial pancreas, Glucose control, Meal
Eligibility Criteria
Inclusion Criteria:
- Males and females ≥ 18 years 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 and currently using fast-acting insulin analog (Lispro, Aspart or Guilisine).
- Last (less than 3 months) HbA1c ≤ 10%.
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 1 month of screening.
- Agents affecting gastric emptying (Motilium®, Prandase®, all GLP-1 analogs) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
- Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhaled steroids at stable dose in the last month are acceptable.
- 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. unstable psychiatric condition).
- Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, etc).
Sites / Locations
- Institut de recherches cliniques de Montréal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Carbohydrate meal
Carbohydrate + fat meal
Carbohydrate + protein meal
Carbohydrate + fat + protein meal
Arm Description
Outcomes
Primary Outcome Measures
Area under the curve of sensor glucose levels
Secondary Outcome Measures
Mean sensor glucose levels
Peak glucose excursion
Time to peak glucose
Percentage of time of sensor glucose concentrations between 3.9 and 7.8 mmol/L
Percentage of time of sensor glucose concentrations between 3.9 and 10 mmol/L
Percentage of time of sensor glucose concentrations above 10 mmol/L
Percentage of time of sensor glucose concentrations above 13.9 mmol/L
Total insulin delivery
Standard deviation of glucose levels
Coefficient of variation of glucose levels
Full Information
NCT ID
NCT02774876
First Posted
May 13, 2016
Last Updated
October 26, 2017
Sponsor
Institut de Recherches Cliniques de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT02774876
Brief Title
Closed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes
Official Title
An Open-label, Randomized, Four-way, Cross-over Study to Examine the Efficacy of Single-hormone Closed-loop System in Regulating Glucose Levels in Adults With Type 1 Diabetes Following Meals of Various Macronutrient Contents: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Carbohydrates are the main determinant of post-meal glucose excursion. However, fat and protein have been shown to also impact the postprandial glucose control, adding to the complexity of meal insulin calculation. Few studies have looked at the effect of macronutrients other than carbohydrates on postprandial glucose excursions with the closed-loop strategy. The objective of this study is to test whether the single-hormone closed-loop strategy can achieve similar post-meal glucose control with meals with a fixed carbohydrate content, but high in protein and/or fat when compared to a meal with a fixed carbohydrate content only.
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, Glucose control, Meal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate meal
Arm Type
Active Comparator
Arm Title
Carbohydrate + fat meal
Arm Type
Active Comparator
Arm Title
Carbohydrate + protein meal
Arm Type
Active Comparator
Arm Title
Carbohydrate + fat + protein meal
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Patient's insulin pump
Intervention Description
The patient's insulin pump will be used to regulate glucose levels.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Patient's usual fast-acting insulin analog will be used.
Intervention Type
Device
Intervention Name(s)
Dexcom G4 Platinum glucose sensor
Intervention Description
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.
Intervention Type
Other
Intervention Name(s)
Single-hormone closed-loop
Intervention Description
Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at IRCM at 6:30 am in a fasting state. At 7:00, single-hormone closed-loop will be initiated. At 8:00, if glucose levels are between 3.5 and 12.5 mmol/L, the meal will be served. Patients will have 20 minutes to consume the meal. If glucose levels are not in this target range, the meal will be delayed for a maximum of 45 minutes. If after 45 minutes, glucoses levels are still not between 3.5 and 12.5 mmol/L, the test will be cancelled and rescheduled. The test meals will be: 1) 75g of CHO; 2) 75g of CHO + 35g of protein; 3) 75g of CHO + 35g of fat; or 4) 75g of CHO + 35g of protein + 35g of fat. The intervention day will end at 13:00.
Primary Outcome Measure Information:
Title
Area under the curve of sensor glucose levels
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Secondary Outcome Measure Information:
Title
Mean sensor glucose levels
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Peak glucose excursion
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Time to peak glucose
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Percentage of time of sensor glucose concentrations between 3.9 and 7.8 mmol/L
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Percentage of time of sensor glucose concentrations between 3.9 and 10 mmol/L
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Percentage of time of sensor glucose concentrations above 10 mmol/L
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Percentage of time of sensor glucose concentrations above 13.9 mmol/L
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Total insulin delivery
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Standard deviation of glucose levels
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
Title
Coefficient of variation of glucose levels
Time Frame
The outcome measure will be calculated over the 5 hours following the breakfast meal given on the single-hormone closed-loop intervention. The 5-hour period is from 8:00 to 13:00.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females ≥ 18 years 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 and currently using fast-acting insulin analog (Lispro, Aspart or Guilisine).
Last (less than 3 months) HbA1c ≤ 10%.
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 1 month of screening.
Agents affecting gastric emptying (Motilium®, Prandase®, all GLP-1 analogs) as well as oral anti-diabetic agents (Metformin, SGLT-2 inhibitors and DPP-4 inhibitors) if not at a stable dose for 3 months. Otherwise, these medications are acceptable and will be kept stable during the entire protocol.
Oral steroids unless patients present a low stable dose (e.g. 10 mg or less of prednisone per day or physiological doses, less than 35 mg/day, of hydrocortisone Cortef®). Inhaled steroids at stable dose in the last month are acceptable.
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. unstable psychiatric condition).
Failure to comply with team's recommendations (e.g. not willing to change pump parameters, follow algorithm's suggestions, 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
Plan to Share IPD
No
Learn more about this trial
Closed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes
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