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

What Was Tested

This registered phase 2 trial tested Insulin (regular human).

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.

It had two arms (groups): Multiple daily injections (active comparator) and Closed-loop strategy (active comparator).

Subjects will use multiple daily injections to regulate glucose levels. Subject's usual insulin analog will be used.

The registry classes the interventions as device, drug and other.

Who Took Part

15 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 \[23\].

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: retinopathy as proliferative retinopathy or recent (\<3 month) eye bleeding or laser therapy. if the patient have undergone panphoto-coagulation inclusion is acceptable; recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery; A recent (\< 2 months) infection needing IV antibiotic or hospitalization.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-10 with completion listed for 2018-09.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of time of plasma glucose concentrations spent in the target range (time frame: 24 hours).

It also tracked 25 secondary outcomes, for example 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 and Number of patients experiencing at least one hypoglycemic event requiring treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.