Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy

Institut de Recherches Cliniques de Montreal15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

24-hour intervention with multiple daily injectionsOTHER

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.

24-hour intervention with closed-loop strategyOTHER

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.

InsulinDRUG

Subject's usual insulin analog will be used.

Insulin pump Accu-Chek ComboDEVICE

During closed-loop intervention, the Accu-Chek Combo (Roche) insulin pump will be used

Dexcom G4 PlatinumDEVICE

In both visits, glucose levels will be measure with the Dexcom G4 Platinum (Dexcom)

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Secondary Outcomes

Percentage of time of plasma glucose levels spent between 4.0 to 10.0 mmol/L

Time frame: 24 hours

Percentage of time of plasma glucose levels spent below 4.0 mmol/L

Time frame: 24 hours

Percentage of time of plasma glucose levels spent below 3.5 mmol/L

Time frame: 24 hours

Percentage of time of plasma glucose levels spent above 8.0 mmol/L

Time frame: 24 hours

Percentage of time of plasma glucose levels spent above 10.0 mmol/L

Time frame: 24 hours

Percentage of time of overnight plasma glucose levels spent below 4.0 mmol/L

Time frame: 8 hours

Percentage of time of overnight plasma glucose levels spent between 4.0 and 8.0 mmol/L

Time frame: 8 hours

Percentage of time of overnight plasma glucose levels spent between 4.0 and 10.0 mmol/L

Time frame: 8 hours

Percentage of time of overnight plasma glucose levels spent below 3.5 mmol/L

Time frame: 8 hours

Percentage of time of overnight plasma glucose levels above 8.0 mmol/L

Time frame: 8 hours

Percentage of time of overnight plasma glucose levels above 10.0 mmol/L

Time frame: 8 hours

Area under the curve of plasma glucose levels below 4.0 mmol/L

Time frame: 24 hours

Area under the curve of plasma glucose levels below 3.5 mmol/L

Time frame: 24 hours

Area under the curve of plasma glucose levels above 8.0 mmol/L

Time frame: 24 hours

Area under the curve of plasma glucose levels above 10.0 mmol/L

Time frame: 24 hours

Area under the curve of overnight plasma glucose levels below 4.0 mmol/L

Time frame: 8 hours

Area under the curve of overnight plasma glucose levels below 3.5 mmol/L

Time frame: 8 hours

Area under the curve of overnight plasma glucose levels above 8.0 mmol/L

Time frame: 8 hours

Area under the curve of overnight plasma glucose levels above 10.0 mmol/L

Time frame: 8 hours

Mean glucose levels

Time frame: 24 hours

Total insulin delivery

Time frame: 24 hours

Standard deviation of plasma glucose concentrations

Time frame: 24 hours

Coefficient of variance of plasma glucose concentrations

Time frame: 24 hours

Number of patients experiencing at least one hypoglycemic event requiring treatment

Time frame: 24 hours

Number of patients experiencing at least one hypoglycemic event requiring treatment

Time frame: 8 hours

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults With Type 2 Diabetes Under Intensive Insulin Therapy

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes