Clinical trial NCT02490085: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Closed-loop strategy
Artificial pancreas
Insulin
Elderly
Multiple daily injections
Hypoglycemia
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
Collaborators: name: Réseau de recherche en santé cardiométabolique, diabète et obésité
First posted: 2015-07-03
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes.
2. Males and females ≥ 55 years of old.
3. Body mass index above 25 kg/m2
4. Non fragile defined based on Moorhouse et al. scale \[23\].
5. 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.
6. HbA1c above 6%.

Exclusion Criteria:

1. Advanced

   1. Nephropathy defined by creatinine clearance \<30 ml/min.
   2. Retinopathy as proliferative retinopathy or recent (\<3 month) eye bleeding or laser therapy. If the patient have undergone panphoto-coagulation inclusion is acceptable.
   3. Autonomic neuropathy with clinically significant gastroparesis according to investigator evaluation.
2. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. 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.
4. A recent (\< 2 months) infection needing IV antibiotic or hospitalization
5. Severe hypoglycemic episode within two weeks of screening.
6. Current use of glucocorticoid medication (by any route of administration except low dose stable inhaled).
7. Recent initiation or dose modification (\<2 months) of therapy known to interfere with glucose metabolism (e.g. neuroleptics, anti-psychotics, etc.)
8. Known or suspected allergy to the trial products or meal contents.
9. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Primary outcomes:
measure: Percentage of time of plasma glucose concentrations spent in the target range
timeFrame: 24 hours
Secondary outcomes:
measure: Percentage of time of plasma glucose levels spent between 4.0 to 10.0 mmol/L
timeFrame: 24 hours
measure: Percentage of time of plasma glucose levels spent below 4.0 mmol/L
timeFrame: 24 hours
measure: Percentage of time of plasma glucose levels spent below 3.5 mmol/L
timeFrame: 24 hours
measure: Percentage of time of plasma glucose levels spent above 8.0 mmol/L
timeFrame: 24 hours
measure: Percentage of time of plasma glucose levels spent above 10.0 mmol/L
timeFrame: 24 hours
measure: Percentage of time of overnight plasma glucose levels spent below 4.0 mmol/L
timeFrame: 8 hours
measure: Percentage of time of overnight plasma glucose levels spent between 4.0 and 8.0 mmol/L
timeFrame: 8 hours
measure: Percentage of time of overnight plasma glucose levels spent between 4.0 and 10.0 mmol/L
timeFrame: 8 hours
measure: Percentage of time of overnight plasma glucose levels spent below 3.5 mmol/L
timeFrame: 8 hours
measure: Percentage of time of overnight plasma glucose levels above 8.0 mmol/L
timeFrame: 8 hours
measure: Percentage of time of overnight plasma glucose levels above 10.0 mmol/L
timeFrame: 8 hours
measure: Area under the curve of plasma glucose levels below 4.0 mmol/L
timeFrame: 24 hours
measure: Area under the curve of plasma glucose levels below 3.5 mmol/L
timeFrame: 24 hours
measure: Area under the curve of plasma glucose levels above 8.0 mmol/L
timeFrame: 24 hours
measure: Area under the curve of plasma glucose levels above 10.0 mmol/L
timeFrame: 24 hours
measure: Area under the curve of overnight plasma glucose levels below 4.0 mmol/L
timeFrame: 8 hours
measure: Area under the curve of overnight plasma glucose levels below 3.5 mmol/L
timeFrame: 8 hours
measure: Area under the curve of overnight plasma glucose levels above 8.0 mmol/L
timeFrame: 8 hours
measure: Area under the curve of overnight plasma glucose levels above 10.0 mmol/L
timeFrame: 8 hours
measure: Mean glucose levels
timeFrame: 24 hours
measure: Total insulin delivery
timeFrame: 24 hours
measure: Standard deviation of plasma glucose concentrations
timeFrame: 24 hours
measure: Coefficient of variance of plasma glucose concentrations
timeFrame: 24 hours
measure: Number of patients experiencing at least one hypoglycemic event requiring treatment
timeFrame: 24 hours
measure: Number of patients experiencing at least one hypoglycemic event requiring treatment
timeFrame: 8 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Rémi Rabasa-Lhoret
role: PRINCIPAL_INVESTIGATOR
References: