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. 2025 Mar;16(3):413-427.
doi: 10.1007/s13300-024-01673-9. Epub 2024 Dec 17.

Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study

Laurence Kessler  1 , Charles Thivolet  2 , Alfred Penfornis  3 , Didier Gouet  4 , Christine Coffin  5 , Myriam Moret  6 , Sophie Borot  7 , Saïd Bekka  8 , Emmanuel Sonnet  9 , Michael Joubert  10 , Sandrine Lablanche  11 , Geoffrey Burtin  12 , Fabio Di Piazza  13 , Tim van den Heuvel  13 , Ohad Cohen  14   15
Affiliations

Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study

Laurence Kessler et al. Diabetes Ther. 2025 Mar.

Erratum in

Abstract

Introduction: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.

Methods: Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.

Results: Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.

Conclusion: In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.

Trial registration: ClinicalTrials.gov identifier, NCT04308291.

Keywords: Advanced hybrid closed loop; Fear of hypoglycemia; France; Glycemic control; Quality of life; Type 1 diabetes mellitus.

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Conflict of interest statement

Declarations. Conflicts of Interest: Laurence Kessler reports consulting fees from Medtronic, Vertex, Abbott, Novo Nordisk; honoraria or payment for lectures, presentations, and educational events from Johnson and Johnson, Lilly Boehringer, Brothier, GSK, AstraZeneca, Sanofi-Aventis, Novartis, BMS, Elivie, Vertex, ASDIA, ISIS Santé, ADIRAL. Charles Thivolet reports personal fees from Abbott Diabetes Care, Glooko, Lilly, Novo Nordisk, Medtronic, and Sanofi and is an advisory board member for Insulet and Medtronic. Alfred Penfornis reports consulting fees from Medtronic, Insulet, Abbott Diabetes, Novo Nordisk, Medtrum, and Sanofi; honoraria or payment for lectures, presentations, speaker bureaus, manuscript writing, and educational events from Novo Nordisk, Medtronic, Insulet, Lilly Diabetes, Sanofi Diabetes, Abbott, AstraZeneca, Dexcom, and Diabeloop; payment for expert testimony and support for travel and attending meetings from Sanofi Diabetes and Isis. Didier Gouet reports honoraria or payment for lectures, presentations in symposium and for participation on advisory board from Lilly, Novo Nordisk, Sanofi, Abbott, Medtronic, Roche, AstraZeneca, LVL, Vitalaire, Isis, NHC, and Dexcom. Christine Coffin reports honoraria or payment for presentations, speaker bureaus and educational events from Novo Nordisk, Medtronic, Insulet, Lilly Diabetes, Sanofi Diabetes and Abbot Diabetes; support for travel and attending meetings from Novo Nordisk and Sanofi. Myriam Moret reports payment for support for travel and attending meetings from Lilly Diabetes, ISIS Diabetes, LVL Médical; was an investigator on studies from URGO Laboratories and from TIMKL. Sophie Borot reports honoraria or payment for lectures, presentations, speaker bureaus, manuscript writing, and educational events from Novo Nordisk, Medtronic, Insulet, Lilly Diabetes, Sanofi Diabetes, and Dexcom. Saïd Bekka reports consulting fees from Novo Nordisk, Lilly Diabetes, Sanofi, Medtronic, Dexcom, AstraZeneca; participation on advisory boards for Medtronic, Lilly, and Novo Nordisk. Emmanuel Sonnet reports consulting fees from Medtronic, Abbott Diabetes, Glooko and Lilly Diabetes; honoraria or payment for lectures, presentations, speaker bureaus, manuscript writing, and educational events from Novo Nordisk, Medtronic, Dexcom, Tandem, Ypsomed, Sanofi Diabetes, and Glooko. Michael Joubert reports consultant and/or speaker fees and/or research support from Abbott, Air Liquide Santé International, Amgen, Asdia, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Dexcom, Dinno Santé, Glooko, Insulet, Lifescan, Lilly, LVL Médical, Medtronic, MSD, Nestlé HomeCare, Novo Nordisk, Organon, Orkyn, Roche Diabetes, Sanofi, Tandem, Vitalaire, Voluntis, and Ypsomed as well as being an Editorial Board member of Diabetes Therapy (Michael Joubert was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions). Sandrine Lablanche reports consulting fees from Medtronic, Dexcom, Ypsomed and Sanofi; honoraria or payment for lectures, presentations, and educational events from Medtronic, Insulet, Lilly Diabetes, Sanofi Diabetes, Vitalaire, Abbott, and Boehringer. Geoffrey Burtin is a current employee of Medtronic. Fabio Di Piazza is a current employee of Medtronic. Tim van den Heuvel is a current employee of Medtronic. Ohad Cohen is a current employee of Medtronic. Ethics/Ethics Approval: All participants or, for minors, their guardians provided informed consent. The study was approved by the French Central Ethics Committee (Comité de Protection des Personnes Sud-Est II; 2019-A01668-49; January 8, 2020) and conducted in accordance with the Helsinki Declaration of 1964 and its later amendments.

Figures

Fig. 1
Fig. 1
Study design schematic. Abbreviations: DQOL Diabetes Quality of Life (instrument), DTSQc/s Change/Status Diabetes Treatment Satisfaction Questionnaire, HbA1c glycated hemoglobin, HFS Hypoglycemia Fear Survey, TIR time in range
Fig. 2
Fig. 2
Patient disposition flowchart
Fig. 3
Fig. 3
Changes at 6 and 12 months from baseline in glycemic categories. Abbreviations: Δ difference, CI confidence interval, dL deciliter, L liter, mg milligram. *p < 0.0001
Fig. 4
Fig. 4
a–e Treatment satisfaction, quality of life, and fear of hypoglycemia trajectories. Abbreviations: DQoL Diabetes Quality of Life (instrument), DTSQs Diabetes Treatment Satisfaction Questionnaire status, HFS Hypoglycemia Fear Survey
See this image and copyright information in PMC

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