Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity.

What Was Tested

The trial (phase 3) is built around Insulin (regular human).

The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.

The study will be conducted in 18 patients.

The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

It had two arms (groups): Proposed treatment by Diabeloop algorithm (experimental) and usual treatment (no intervention).

The registry classes the interventions as drug.

More on the Plan

Groups of patients are described as follows: * Group I: patients have a meal with the usual carbohydrate intake.

After signing the consent, the investigator shall designate one group for each patient. * Visit V2 (24 hours before the visit V3): Installation, calibration and education of two glucose sensors dexcom G4 ™ will be performed by a nurse.

The patient will keep two sensors until the end of the study (end of V4). * Visit V3 (algorithm test): Patient will be fitted with its insulin pump and the two sensors dexcom G4 ™.

These will be coupled by the engineer LETI to the computer on which is installed the control algorithm to be tested.

Who Took Part

The registry lists 18 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients with type 1 diabetes treated by external insulin pump;. Patients aged 18 years or less;. Patient who signed consent;. Patient affiliated with Social Security. Patient is practicing functional insulin therapy is a fixed meal plan.

How the Study Was Run

Design: non-randomized, crossover and open-label.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2013-03 with completion listed for 2013-06.

It ran at 3 sites in France (3).

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): Time spent in glucose reference intervals (time frame: After the end of the tests).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Insulin (regular human) in 18 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.