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Closed-Loop System Boosts Diabetes Glucose Control

Diabetes word cloud

(Diabetes Care, Flickr)

29 Apr. 2019. A clinical trial shows an algorithm-driven glucose monitor and insulin pump system provides better control of glucose levels for people with type 1 diabetes than an insulin pump alone. Results of the trial appear today in the inaugural issue of the journal The Lancet Digital Health.

Participants in the trial were people in France with type 1 diabetes, an inherited autoimmune disorder where beta cells in the pancreas do not produce insulin. Type 1 diabetes is diagnosed primarily in children or young adults, where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells. From 5 to 10 percent of people diabetes have the type 1 form.

The study tested a closed-loop system made by the company Diabeloop in Grenoble, France combining real-time glucose monitoring with an insulin pump and a mobile phone handset that controls its operation. The system, known as the Diabeloop Generation 1, or DBLG1, uses a commercially-made glucose monitor and insulin pump worn on the abdomen and arm respectively, connected with Bluetooth transmissions. The system is controlled by a machine-learning algorithm in software written by Diabeloop that combines blood glucose readings made every 5 minutes by the monitor, with data entered by the wearer on food intake and exercise.  The algorithm calculates those data with the individual’s personal history to calculate an insulin dose. The handset can also transmit data to the cloud for distribution to the wearer’s physician.

The clinical trial enrolled 68 adult participants with type 1 diabetes at 12 sites in France, sponsored by a not-for profit organization, Centre d’études et de recherches pour l’intensification du traitement du diabète, or Ceritd. The study, led by Pierre Yves Benhamou, an endocrinologist and diabetes specialist at Grenoble University Hospital, tested the DBLG1 system against a continuous glucose monitor and insulin pump that participants controlled themselves, now considered the standard of care.

After a 2-week training period, participants were randomly assigned to wear the DBLG1 system or use the glucose monitor and insulin pump alone for 12 weeks. Then after an 8-week wash-out period of using none of the devices, the 2 groups switched technologies and reported results for another 12 weeks. The study team looked primarily at the amount of time participants spent within safe glucose levels. The researchers also tracked periods and events outside of that safe glucose range, total insulin use, technical problems with the devices, and any adverse effects during the trial.

Of the original 68 eligible recruits for the study, 5 dropped out mainly due to pregnancy during the trial. The amount of time, on average, participants spent within safe glucose levels was higher for DBLG1 participants (69%) than glucose monitor and insulin pump wearers (59%), a difference large enough for statistical reliability. However 5 episodes of low blood sugar levels occurred among the DBLG1 participants, compared to 3 incidents for the glucose-monitor and insulin pump group, which the researchers said were associated with hardware malfunctions or human error.

The researchers say the results support using closed-loop systems like the DBLG1 for people with type 1 diabetes. A clinical trial in Europe testing the Medtronic 640G closed-loop system against an insulin pump returned similar results, as reported by Science & Enterprise in October 2018. The following video tells more about the later study.

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