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Excellent results from first clinical trials set

22/02/2017

As announced in January 31st news, results from the first set of clinical trial have been presented and explained last week during ATTD 2017.

 

A short reminder: the clinical trial involved 9 investigation centers and 40 people, separated into 3 groups:

  • sedentary: patients received meals whose glucid quantity was calculated in advance, did not practice any physical activity and did not eat any heavy meals.
  • heavy meal: patients had their dinner in a restaurant, italian meal,  asian meal and gastronomic meal.
  • physical activity: patients practiced moderate and/or intense physical activities during the day and received regular meals.

All trials were in crossover, meaning each groups tested both a closed loop system using Diabeloop device, and an open loop without Diabeloop system, in the same condition.

 

Our study first targeted the time spent in normoglycemia during the night (from 11pm to 7:30am) and then during the entire day (over 24 hours), with secondary data regarding the average glycemia, time spent in normoglycemia over the 24 hours,  time spent in hypoglycemia and patient satisfaction with the system.

Results are the following:

  • Globally, patients spent twice more time in normoglycemia when using Diabeloop system. Post-trials questionnaires show a overall satisfaction of the system compared to patient’s usual treatment.
  • Under heavy meal condition, Diabeloop system:
    • Triples the time spent in normoglycemia during nights following the gastronomic dinners
    • Decreases by nearly 30 mg/dl the average glycemia during the whole 3 days period
    • Shows a downward trend in hypoglycemia even if this result is not statistically significant
  • Under physical activity condition, Diabeloop system:
    • Doubles the time spent in normoglycemia during the nights
    • Decreases by nearly 20 mg/dl the average glycemia during the whole period
    • Shows a downward trend in hypoglycemia even if this result is not statistically significant

 

Our motivation gets even bigger with this excellent and very promising results!

ATTD2017_Diabeloop_RepasExtraordinaires_sm

Poster 1 ATTD 2017

Poster 2 ATTD 2017

ATTD 2017 – presentation 1

ATTD 2017 – presentation 2