Back to resultsClosed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
24-hour intervention with multiple daily injections
24-hour intervention with closed-loop strategy
Insulin
Insulin pump Accu-Chek Combo
Dexcom G4 Platinum
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Closed-loop strategy, Artificial pancreas, Insulin, Elderly, Multiple daily injections, Hypoglycemia
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes.
- Males and females ≥ 55 years of old.
- Body mass index above 25 kg/m2
- Non fragile defined based on Moorhouse et al. scale [23].
- Using at least 3 insulin injections per day. However, basal insulin injection must be injected at bedtime without injection of basal insulin in the morning. Combination with any other anti-diabetic therapy is acceptable as long at this therapy was introduced at least 6 weeks prior the 1s intervention and is kept stable all along the protocol.
- HbA1c above 6%.
Exclusion Criteria:
Advanced
- Nephropathy defined by creatinine clearance <30 ml/min.
- Retinopathy as proliferative retinopathy or recent (<3 month) eye bleeding or laser therapy. If the patient have undergone panphoto-coagulation inclusion is acceptable.
- Autonomic neuropathy with clinically significant gastroparesis according to investigator evaluation.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- A recent (< 2 months) injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the ability to walk.
- A recent (< 2 months) infection needing IV antibiotic or hospitalization
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
- Recent initiation or dose modification (<2 months) of therapy known to interfere with glucose metabolism (e.g. neuroleptics, anti-psychotics, etc.)
- Known or suspected allergy to the trial products or meal 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.
Sites / Locations
- Institut de recherches cliniques de Montréal
- Centre hospitalier universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Multiple daily injections
Closed-loop strategy
Arm Description
Subjects will use multiple daily injections to regulate glucose levels. Subject's usual insulin analog will be used.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Subject's usual fast-acting insulin analog will be infused using a subcutaneous infusion pumps (Accu-Chek Combo, Roche). The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom) will be entered manually into the computer every 10 minutes. The pumps' infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
Outcomes
Primary Outcome Measures
Percentage of time of plasma glucose concentrations spent in the target range
The target range is defined as between 4.0 and 10.0 mmol/L 2-hour postprandial and between 4.0 to 8.0 mmol/L otherwise.
Secondary Outcome Measures
Percentage of time of plasma glucose levels spent between 4.0 to 10.0 mmol/L
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Percentage of time of plasma glucose levels spent below 3.5 mmol/L
Percentage of time of plasma glucose levels spent above 8.0 mmol/L
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Percentage of time of overnight plasma glucose levels spent below 4.0 mmol/L
Percentage of time of overnight plasma glucose levels spent between 4.0 and 8.0 mmol/L
Percentage of time of overnight plasma glucose levels spent between 4.0 and 10.0 mmol/L
Percentage of time of overnight plasma glucose levels spent below 3.5 mmol/L
Percentage of time of overnight plasma glucose levels above 8.0 mmol/L
Percentage of time of overnight plasma glucose levels above 10.0 mmol/L
Area under the curve of plasma glucose levels below 4.0 mmol/L
Area under the curve of plasma glucose levels below 3.5 mmol/L
Area under the curve of plasma glucose levels above 8.0 mmol/L
Area under the curve of plasma glucose levels above 10.0 mmol/L
Area under the curve of overnight plasma glucose levels below 4.0 mmol/L
Area under the curve of overnight plasma glucose levels below 3.5 mmol/L
Area under the curve of overnight plasma glucose levels above 8.0 mmol/L
Area under the curve of overnight plasma glucose levels above 10.0 mmol/L
Mean glucose levels
Total insulin delivery
Standard deviation of plasma glucose concentrations
Coefficient of variance of plasma glucose concentrations
Number of patients experiencing at least one hypoglycemic event requiring treatment
Number of patients experiencing at least one hypoglycemic event requiring treatment
Full Information
NCT ID
NCT02490085
First Posted
July 1, 2015
Last Updated
June 7, 2019
Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
Réseau de recherche en santé cardiométabolique, diabète et obésité
1. Study Identification
Unique Protocol Identification Number
NCT02490085
Brief Title
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy
Official Title
An Open-label, Randomized, Two-way, Cross-over Multicenter Study to Assess the Efficacy of Closed-loop Strategy as Compared to Multiple Daily Injections in Regulating Glucose Levels During 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal
Collaborators
Réseau de recherche en santé cardiométabolique, diabète et obésité
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The introduction of insulin pump therapy in patients with type 2 diabetes using multiple daily injections and poorly controlled can be considered in order to improve glycemic control. Recent developments of continuous glucose sensors and insulin infusion pumps have motivated the research toward "closed-loop'' strategies to regulate glucose levels for patients with diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a computer generated recommendation that rely on continuous glucose sensor readings. This study confirmed the feasibility and potential of the closed-loop strategy to improve glycemic control while reducing the risk of hypoglycemia in patients with type 2 diabetes but did not target the population most likely to benefit from this strategy.The objective ot this study is to compare the efficacy of closed-loop strategy to multiple daily injections in regulating glucose levels for 24 hours in elderly adults with type 2 diabetes under intensive insulin therapy. The investigators hypothesize that closed-loop strategy will increase the time spent in the target range in adults with type 2 diabetes compared to multiple daily injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Closed-loop strategy, Artificial pancreas, Insulin, Elderly, Multiple daily injections, Hypoglycemia
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
Multiple daily injections
Arm Type
Active Comparator
Arm Description
Subjects will use multiple daily injections to regulate glucose levels. Subject's usual insulin analog will be used.
Arm Title
Closed-loop strategy
Arm Type
Active Comparator
Arm Description
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Subject's usual fast-acting insulin analog will be infused using a subcutaneous infusion pumps (Accu-Chek Combo, Roche). The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom) will be entered manually into the computer every 10 minutes. The pumps' infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
Intervention Type
Other
Intervention Name(s)
24-hour intervention with multiple daily injections
Intervention Description
Subjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. The subjects will carry on with their normal insulin therapy. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.
Intervention Type
Other
Intervention Name(s)
24-hour intervention with closed-loop strategy
Intervention Description
Subjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing subject's usual fast acting insulin analog will be placed in the insulin pump. Closed-loop strategy will start at 21:00 until 21:00 the next day. Neither basal nor prandial insulin injections will be given. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Subject's usual insulin analog will be used.
Intervention Type
Device
Intervention Name(s)
Insulin pump Accu-Chek Combo
Intervention Description
During closed-loop intervention, the Accu-Chek Combo (Roche) insulin pump will be used
Intervention Type
Device
Intervention Name(s)
Dexcom G4 Platinum
Intervention Description
In both visits, glucose levels will be measure with the Dexcom G4 Platinum (Dexcom)
Primary Outcome Measure Information:
Title
Percentage of time of plasma glucose concentrations spent in the target range
Description
The target range is defined as between 4.0 and 10.0 mmol/L 2-hour postprandial and between 4.0 to 8.0 mmol/L otherwise.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Percentage of time of plasma glucose levels spent between 4.0 to 10.0 mmol/L
Time Frame
24 hours
Title
Percentage of time of plasma glucose levels spent below 4.0 mmol/L
Time Frame
24 hours
Title
Percentage of time of plasma glucose levels spent below 3.5 mmol/L
Time Frame
24 hours
Title
Percentage of time of plasma glucose levels spent above 8.0 mmol/L
Time Frame
24 hours
Title
Percentage of time of plasma glucose levels spent above 10.0 mmol/L
Time Frame
24 hours
Title
Percentage of time of overnight plasma glucose levels spent below 4.0 mmol/L
Time Frame
8 hours
Title
Percentage of time of overnight plasma glucose levels spent between 4.0 and 8.0 mmol/L
Time Frame
8 hours
Title
Percentage of time of overnight plasma glucose levels spent between 4.0 and 10.0 mmol/L
Time Frame
8 hours
Title
Percentage of time of overnight plasma glucose levels spent below 3.5 mmol/L
Time Frame
8 hours
Title
Percentage of time of overnight plasma glucose levels above 8.0 mmol/L
Time Frame
8 hours
Title
Percentage of time of overnight plasma glucose levels above 10.0 mmol/L
Time Frame
8 hours
Title
Area under the curve of plasma glucose levels below 4.0 mmol/L
Time Frame
24 hours
Title
Area under the curve of plasma glucose levels below 3.5 mmol/L
Time Frame
24 hours
Title
Area under the curve of plasma glucose levels above 8.0 mmol/L
Time Frame
24 hours
Title
Area under the curve of plasma glucose levels above 10.0 mmol/L
Time Frame
24 hours
Title
Area under the curve of overnight plasma glucose levels below 4.0 mmol/L
Time Frame
8 hours
Title
Area under the curve of overnight plasma glucose levels below 3.5 mmol/L
Time Frame
8 hours
Title
Area under the curve of overnight plasma glucose levels above 8.0 mmol/L
Time Frame
8 hours
Title
Area under the curve of overnight plasma glucose levels above 10.0 mmol/L
Time Frame
8 hours
Title
Mean glucose levels
Time Frame
24 hours
Title
Total insulin delivery
Time Frame
24 hours
Title
Standard deviation of plasma glucose concentrations
Time Frame
24 hours
Title
Coefficient of variance of plasma glucose concentrations
Time Frame
24 hours
Title
Number of patients experiencing at least one hypoglycemic event requiring treatment
Time Frame
24 hours
Title
Number of patients experiencing at least one hypoglycemic event requiring treatment
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes.
Males and females ≥ 55 years of old.
Body mass index above 25 kg/m2
Non fragile defined based on Moorhouse et al. scale [23].
Using at least 3 insulin injections per day. However, basal insulin injection must be injected at bedtime without injection of basal insulin in the morning. Combination with any other anti-diabetic therapy is acceptable as long at this therapy was introduced at least 6 weeks prior the 1s intervention and is kept stable all along the protocol.
HbA1c above 6%.
Exclusion Criteria:
Advanced
Nephropathy defined by creatinine clearance <30 ml/min.
Retinopathy as proliferative retinopathy or recent (<3 month) eye bleeding or laser therapy. If the patient have undergone panphoto-coagulation inclusion is acceptable.
Autonomic neuropathy with clinically significant gastroparesis according to investigator evaluation.
Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
A recent (< 2 months) injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the ability to walk.
A recent (< 2 months) infection needing IV antibiotic or hospitalization
Severe hypoglycemic episode within two weeks of screening.
Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
Recent initiation or dose modification (<2 months) of therapy known to interfere with glucose metabolism (e.g. neuroleptics, anti-psychotics, etc.)
Known or suspected allergy to the trial products or meal 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi 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
Facility Name
Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
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Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy
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