Comparison of an Artificial Pancreas Versus Threshold Low Glucose Suspend in Type 1 Diabetic Children

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Lispro.

After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings.

During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization.

It had two arms (groups): Control-to-Range algorithm and Threshold Low Glucose Suspend (experimental) and Threshold Low Glucose Suspend and Control-to-Range algorithm (experimental).

On this arm, patients will realize two investigational sessions: * the first with Control-to-Range algorithm (CTR), * the second with Threshold Low Glucose Suspend (TLGS).

On this arm, patients will realize two investigational sessions: * the first with Threshold Low Glucose Suspend (TLGS), * the second with Control-to-Range algorithm (CTR).

The registry classes the interventions as device.

More on the Plan

The study is an open randomized control trial preceded by a run-in period and follows a cross-over design.After inclusion, the therapy will be moved to sensor augmented pump therapy with a dedicated training to continuous glucose monitoring using study system (study CGM).

During 2 to 3 weeks, the patient will use his/her usual insulin pump and the study CGM (run-in period).

Admission will be at 17:00 Day 1.

The investigator will connect wirelessly the study pump and CGM to the study platform DiAs and remote monitoring will be activated.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 7 years up to 12 years.

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

Examples of who could join: Age from 7 to 12. Puberty status at Prader 1. Diabetes diagnosed according to WHO criteria since more than 1 year. At least one positiveness for plasma antibodies against pancreatic islets: IAA, IA2, GAD, ICA or ZnT8, since diagnosis of diabetes. Treatment of diabetes by insulin pump since more than 6 months.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: unwillingness of one parent or the legally responsible party to be present during all study procedures; expected use of acetaminophen-containing drugs; any disease or therapy (except insulin) affecting glucose metabolism during previous month.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

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

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

It started in 2015-06-16 with completion listed for 2016-12.

It ran at 4 sites in France (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time spent with blood glucose <[amount hidden]/dl.

It also tracked 10 secondary outcomes, for example Mean blood glucose level, Mean blood glucose level, Number of needed interventions by the patients, the parents, and by the investigational team, to treat hypoglycemia, Score of the Artificial Pancreas Acceptance Questionnaire and Score of the Hypo Fear Survey.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 24 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 Lispro compound page, all human trials.