In “real life”, the artificial pancreas proves itself in adults and children

Posted byadmin Posted onApril 3, 2024 Comments0
In “real life”, the artificial pancreas proves itself in adults and children

Toulouse, France – According to the preliminary results of the Closed Loop Observatory in France (OB2F), presented during the congress of the Francophone Diabetes Society (1), the use of the artificial pancreas (“semi-closed loop”) in real-world conditions in individuals with type 1 diabetes confirms the conclusions of clinical trials, with an increase in the time spent in the blood glucose target and an improvement in glycemic control . This applies to both adults and children with type 1 diabetes.

The Closed Loop Observatory

The effectiveness of automated insulin therapy is well established, as supported by a recent meta-analysis of 11 randomized clinical trials (2), with notably + 10.3% time spent within the glycemic target (TIR). However, its use in real life conditions still required clarification. Indeed, published studies lack clinical information, in particular on severe hypoglycemia, ketoacidosis and premature cessation of use of the system.

To fill these gaps, the French-speaking Diabetes Society initiated the Closed Loop Observatory in France (OB2F) (3). Preliminary results were presented at the SFD 2024 congress, with inclusion closing on October 13, 2023. The main objective of the study was to evaluate the evolution of glycemic control after 12 months of use of a closed loop in real conditions (Medtronic 780G, Tandem T slim). The primary endpoint was change in the percentage of time spent within the 70-180 mg/dL target (TIR) ​​over a 15-day period, compared to the 15 days prior to activation of the closed loop system.

The study included 2747 patients, including 567 children, across 72 centers. Adult patients had a mean age of 46 years and a mean diabetes duration of 23 years. The preliminary analysis presented in Toulouse by the Professor Jean-Pierre Riveline (Lariboisière Hospital, APHP, Paris), main instigator of OB2F, concerns 1143 adult patients (53 centers; data extraction December 2023) and, according to these first data, real life matches clinical trials.

An improvement in metabolism after 12 months under semi-closed loop

The average HbA1c fell from 7.6% to 7% over a period of 12 months for the 1143 patients followed during this period. Time in Target (TIR) ​​increased from 60% to 70%. At the start of the study, severe hypoglycemia was present in 4.7% of patients (over the past year) and ketoacidosis in 1.8%, while at 12 months, these rates respectively fell to 1 .1% and 0.7%.

In addition, adherence to treatment appears high, with 96.8% of patients still on closed loop at 12 months. The majority of decisions to stop came from patients, mainly because the system was considered restrictive. “This continuity in the use of the system was associated with a significant improvement in HbA1c of 0.6%, as indicated by Professor Riveline, as well as an increase in the time spent in the blood glucose target (TIR ), and a reduction in the number of severe hypoglycemia and incidents of ketoacidosis. »

Thanks to the closed loop, twice as many patients reached 7% HbA1c

At 12 months, 45.9% of participants had glycated hemoglobin below 7%, compared to 20.7% at the start of the study. In addition, 54.8% spent more than 70% of the time within the blood sugar target, compared to 23.8% at baseline. The coefficient of variation decreased from 36.6% to 35.5%.

Regarding the time spent below the glycemic target set at 4% (TBR<4%), 73.8% of participants were there at inclusion. They were 84.3% at one year. The composite parameter of time spent in the glycemic target greater than 70% and time spent below the glycemic target less than 4% (TIR>70% and TBR<4%) was achieved by 15.7 % of participants at inclusion and by 47.6% of them at one year. Those who did not meet these criteria had slightly less favorable HbA1c at one year (7.8% versus 7.4%) and a time spent in target blood glucose (TIR) ​​of 55.2% versus 64.5%. .

OB2F: share of adult patients at target

Were these results predictable? “No,” replies Jean-Pierre Riveline, according to a 2024 publication in Diabetes Care based on an American register (4), 16% of patients on automated insulin therapy had severe hypoglycemia in the United States, a worrying percentage. »

However, approximately 50% of the adult population in OB2F does not meet glycemic goals, highlighting the importance of education and structured monitoring. Progress is expected in the field of automated insulin therapy, particularly with the improvement of algorithms and the exemption from reporting meals or physical exercise. This may allow you to gain points with regard to improving your blood sugar levels.

A point to note: the first participants included in OB2F, according to the recommendations of SFD experts in 2020 (5) (which largely inspired the international recommendations that followed), were relatively well-controlled diabetic patients. The gradual opening of eligibility criteria for artificial pancreas therapy to individuals with less optimal glycemic control suggests even better results.

And in children?

The pediatric results of OB2F were presented by the Dr. Elisabeth Bonnemaison (Clinique Saint Jean – Saint Jean de Vedas Montpellier Métropole), pediatrician, specialized in the management of type 1 diabetes in children and adolescents/young adults. OB2F is the first French observatory on the use of technologies in childhood diabetes.

Between January 1 and December 31, 2022, 480 type 1 diabetic children were placed under closed loop. Their average age was 12 years, with a range of 7 to 17 years. 43% were under 12 years old. On average, the duration of diabetes was 6 years. 67% were already on a pump/sensor. At inclusion, the average glycated hemoglobin (HbA1c) level was 7.5%. 78% had a TBR < 4%, while only 12.5% ​​had a TIR > 70%. Around a quarter (24%) had an HbA1c below 7%.

As in adults, the results obtained by small patients under closed loop are very satisfactory and more of them at one year met the glycemic balance according to the ISPAD recommendations. (6) (defined by a TIR (time within target) greater than 70%, a TBR (time spent in hypoglycemia) less than 4%, and an HbA1c less than 7%). At one year, 47.8% of children had an HbA1c below 7%, compared to 24% at inclusion. Likewise, 38% of children had a TIR less than 70% at one year, compared to 12.5% ​​at inclusion. The TBR remained unchanged (78% of children). Regarding the composite criterion (TIR + TBR), it was reached by 26.5% of children at one year, compared to 8.3% at inclusion.

OB2F: share of child patients at target

“The first results from OB2F confirm the effectiveness of the semi-closed loop on glycemic control in the pediatric population from 6 months of use, with results maintained over 12 months,” commented Dr. Elisabeth Bonnemaison. In addition, its use does not pose security problems, with a low system abandonment rate at one year. »

Links of interest from experts:

Links of interest of Professor JP Riveline: Air Liquide, Sanofi, MSD, Eli Lilly, Novo Nordisk, Astrazeneca, Abbott, Dexcom, Alphadiab, Insulet, Medtronic, Roche.

Links of interest for Dr. Elisabeth Bonnemaison: Air Liquide santé, Sanofi-Aventis, Abbott, Medtronic, Novo Nordisk, Insulet, ISIS, Nestlé Home Care.

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