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

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.