Closed-loop insulin therapy for people with type 2 diabetes treated with an insulin pump: a 12-week multicenter, open-label randomized, controlled, crossover trial
Open accessAbstract
OBJECTIVE: Continuous glucose monitoring (CGM) combined with continuous subcutaneous insulin infusion (CSII) achieves better glycemic control than multi-injection therapy in people with type 2 diabetes. The effectiveness of closed-loop therapy needs to be further evaluated in this population. RESEARCH DESIGN AND METHODS: The study objective was to measure the impact of a hybrid closed-loop device (DBLG1) compared with CSII + CGM on glycemic control in people with type 2 diabetes previously treated with CSII. The randomized, controlled, crossover, two-period, open-label, and multicenter study was conducted from August 2022 to July 2023 in 17 individuals (9 to receive 6 weeks of CSII + CGM first and 8 to receive 6 weeks of closed-loop therapy first). The primary end point was the percentage time in range (TIR: 70–180 mg/dL). Secondary outcomes were other CGM-glucose metrics, physical activity, and sleep objectively measured using 1-week actimetry. RESULTS: Data were analyzed using a modified intention-to-treat approach. Mean age was 63 (SD 9) years and 35% were women. Mean HbA1c at inclusion was 7.9% (SD 0.9). TIR increased to 76.0% (interquartile range 69.0–84.0) during the closed-loop condition vs. 61.0% (interquartile range 55.0–70.0) during the CSII + CGM condition; mean difference was 15.0 percentage points (interquartile range 8.0–22.0; P < 0.001). Analyses of secondary end points showed a decrease in time above range, in glucose management indicator, in glucose variability, and an increase in daily insulin dose. Actimetric sleep analysis showed an improvement in sleep fragmentation during closed-loop treatment. CONCLUSIONS: Closed-loop therapy improved glycemic control more than did CSII + CGM in people with type 2 diabetes.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In that crossover trial, total daily insulin dose increased while on AID.
“Of note, an increase in total daily insulin dose was noted in the subjects while on the AID system (249), whereas other studies have shown either nonsignificant trends for a lower total daily dose of insulin in the AID group (250) or a reduction of total daily insulin in the AID group previously using MDI (251).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [249]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Battelino, T., Danne, T., Bergenstal, R. M., Amiel, S. A., Beck, R., Biester, T., Bosi, E., Buckingham, B. A., Cefalu, W. T., Close, K. L., et al. (2019) · Diabetes Care · doi:10.2337/dci19-0028 · Cited by 4,032 · see citing works
Davies, M. J., Aroda, V. R., Collins, B. S., Gabbay, R. A., Green, J., Maruthur, N. M., Rosas, S. E., Del Prato, S., Mathieu, C., Mingrone, G., et al. (2022) · Diabetes Care · doi:10.2337/dci22-0034 · Cited by 2,104 · see citing works
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
Brown, S. A., Kovatchev, B. P., Raghinaru, D., Lum, J. W., Buckingham, B. A., Kudva, Y. C., Laffel, L. M., Levy, C. J., Pinsker, J. E., Wadwa, R. P., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1907863 · Cited by 1,030 · see citing works
Excess Mortality among Persons with Type 2 Diabetes
Tancredi, M., Rosengren, A., Svensson, A., Kosiborod, M., Pivodic, A., Guðbjörnsdóttir, S., Wedel, H., Clements, M. A., Dahlqvist, S., & Lind, M. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1504347 · Cited by 996 · see citing works
Continuous glucose monitoring and metrics for clinical trials: an international consensus statement
Battelino, T., Alexander, C. M., Amiel, S. A., Arreaza-Rubin, G., Beck, R. W., Bergenstal, R. M., Buckingham, B. A., Carroll, J., Ceriello, A., Chow, E., et al. (2023) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(22)00319-9 · Cited by 831 · see citing works
Holt, R. I. G., DeVries, J. H., Hess-Fischl, A., Hirsch, I. B., Kirkman, M. S., Klupa, T., Ludwig, B., Nørgaard, K., Pettus, J., Renard, E., et al. (2021) · Diabetes Care · doi:10.2337/dci21-0043 · Cited by 699 · see citing works
Lu, J., Ma, X., Zhou, J., Zhang, L., Mo, Y., Ying, L., Lu, W., Zhu, W., Bao, Y., Vigersky, R. A., et al. (2018) · Diabetes Care · doi:10.2337/dc18-1131 · Cited by 517 · see citing works
Tauschmann, M., Thabit, H., Bally, L., Allen, J. M., Hartnell, S., Wilinska, M. E., Ruan, Y., Sibayan, J., Kollman, C., Cheng, P., et al. (2018) · The Lancet · doi:10.1016/s0140-6736(18)31947-0 · Cited by 440 · see citing works
Brown, S. A., Forlenza, G. P., Bode, B. W., Pinsker, J. E., Levy, C. J., Criego, A. B., Hansen, D. W., Hirsch, I. B., Carlson, A. L., Bergenstal, R. M., et al. (2021) · Diabetes Care · doi:10.2337/dc21-0172 · Cited by 286 · see citing works
Reznik, Y., Cohen, O., Aronson, R., Conget, I., Runzis, S., Castaneda, J., & Lee, S. W. (2014) · The Lancet · doi:10.1016/s0140-6736(14)61037-0 · Cited by 233 · see citing works
Closed-loop insulin delivery for glycemic control in noncritical care
Bally, L., Thabit, H., Hartnell, S., Andereggen, E., Ruan, Y., Wilinska, M. E., Evans, M. L., Wertli, M. M., Coll, A. P., Stettler, C., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1805233 · Cited by 232 · see citing works
Carlson, A. L., Sherr, J. L., Shulman, D. I., Garg, S. K., Pop-Busui, R., Bode, B. W., Lilenquist, D. R., Brazg, R. L., Kaiserman, K. B., Kipnes, M. S., et al. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2021.0319 · Cited by 230 · see citing works
Benhamou, P.-Y., Franc, S., Reznik, Y., Thivolet, C., Schaepelynck, P., Renard, E., Guerci, B., Chaillous, L., Lukas-Croisier, C., Jeandidier, N., et al. (2019) · The Lancet Digital Health · doi:10.1016/s2589-7500(19)30003-2 · Cited by 217 · see citing works
Self-citationHaak, T., Hanaire, H., Ajjan, R., Hermanns, N., Riveline, J.-P., & Rayman, G. (2017) · Diabetes Therapy · doi:10.1007/s13300-017-0255-6 · Cited by 188 · see citing works
Positioning time in range in diabetes management
Advani, A. (2020) · Diabetologia · doi:10.1007/s00125-019-05027-0 · Cited by 170 · see citing works
Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial
Thabit, H., Hartnell, S., Allen, J. M., Lake, A., Wilinska, M. E., Ruan, Y., Evans, M. L., Coll, A. P., & Hovorka, R. (2016) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(16)30280-7 · Cited by 141 · see citing works
Boughton, C. K., Tripyla, A., Hartnell, S., DALY, A. B., Herzig, D., Wilinska, M. E., Czerlau, C., Fry, A. C., Bally, L., & Hovorka, R. (2021) · Nature Medicine · doi:10.1038/s41591-021-01453-z · Cited by 126 · see citing works
Daly, A. B., Boughton, C. K., Nwokolo, M., Hartnell, S., Wilinska, M. E., Cezar, A., Evans, M. L., & Hovorka, R. (2023) · Nature Medicine · doi:10.1038/s41591-022-02144-z · Cited by 120 · see citing works
Boughton, C. K., Bally, L., Martignoni, F., Hartnell, S., Herzig, D., Vogt, A. P., Wertli, M. M., Wilinska, M. E., Evans, M. L., Coll, A. P., et al. (2019) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(19)30061-0 · Cited by 110 · see citing works
Yoo, J. H., Choi, M. S., Ahn, J., Park, S. W., Kim, Y., Hur, K. Y., Jin, S., Kim, G., & Kim, J. H. (2020) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2019.0499 · Cited by 102 · see citing works
Uhl, S., Choure, A., Rouse, B., Loblack, A., & Reaven, P. (2024) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgad652 · Cited by 76 · see citing works
Feasibility of Closed-Loop Insulin Delivery in Type 2 Diabetes: A Randomized Controlled Study
Kumareswaran, K., Thabit, H., Leelarathna, L., Caldwell, K., Elleri, D., Allen, J. M., Nodale, M., Wilinska, M. E., Evans, M. L., & Hovorka, R. (2013) · Diabetes Care · doi:10.2337/dc13-1030 · Cited by 66 · see citing works
Herzig, D., Suhner, S., Roos, J., Schürch, D., Cecchini, L., Nakas, C. T., Weiss, S., Kadner, A., Kocher, G. J., Guensch, D. P., et al. (2022) · Diabetes Care · doi:10.2337/dc22-0438 · Cited by 50 · see citing works
Sleep quality and glycaemic variability in a real-life setting in adults with type 1 diabetes
Brandt, R., Park, M., Wroblewski, K., Quinn, L. T., Tasali, E., & Çınar, A. (2021) · Diabetologia · doi:10.1007/s00125-021-05500-9 · Cited by 46 · see citing works
Amer, B. E., Yaqout, Y. E., Abozaid, A. M., Afifi, E., & Aboelkhier, M. M. (2023) · Diabetic Medicine · doi:10.1111/dme.15196 · Cited by 35 · see citing works
Reznik, Y., Carvalho, M., Fendri, S., Prevost, G., Chaillous, L., Riveline, J. P., Hanaire, H., Dubois, S., Houéto, P., Pasche, H., et al. (2024) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.15351 · Cited by 34 · see citing works
Daily variations in sleep and glucose in adolescents with type 1 diabetes
Griggs, S. A., Redeker, N. S., Jeon, S., & Grey, M. J. (2020) · Pediatric Diabetes · doi:10.1111/pedi.13117 · Cited by 32 · see citing works
Mita, T., Katakami, N., Okada, Y., Yoshii, H., Osonoi, T., Nishida, K., Shiraiwa, T., Kurozumi, A., Taya, N., Wakasugi, S., et al. (2023) · Diabetologia · doi:10.1007/s00125-023-06013-3 · Cited by 28 · see citing works
Betry, C., Lablanche, S., Carvalho, M., Amougay, H., Boullay, H. D., Crand, A., Lamy, C., Borges, L., Gorain, S., Borel, J., et al. (2023) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2023.110698 · Cited by 6 · see citing works
Self-citationDeberles, E., Morello, R., Hardouin, J., Amadou, C., Benhamou, P., Prévost, G., Schaepelynck, P., Chaillous, L., Joubert, M., & Reznik, Y. (2021) · Diabetes & Metabolism · doi:10.1016/j.diabet.2021.101300 · Cited by 5 · see citing works
Self-citationBenhamou, P., Madrolle, S., Lablanche, S., Gallegos, A., Tourki, Y., Franc, S., Doron, M., & Charpentier, G. (2020) · Diabetes Care · doi:10.2337/dc20-1291 · Cited by 1 · see citing works
Self-citation
Flagged first, then by citations
Research works printed but not linked: 1
- [3]Fosse-Edorh SPC, Saboni L, Mandereau-Bruno L,. Études Entred: un dispositif pour améliorer la connaissance de l’état de santé des personnes présentant un diabète en France – Premiers résultats de la troisième édition conduite en métropole en 2019. Bull Epidémiol Hebd 2022; 22: 383– 392
Cited by
Sorted by citations
7. Diabetes Technology: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Echouffo-Tcheugui, J. B., Ekhlaspour, L., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s007 · Cited by 348 · see citing works
- Authors
- Borel, A.-L., Lablanche, S., Waterlot, C., Joffray, E., Barra, C., Arnol, N., Amougay, H., & Benhamou, P.-Y.
- Affiliations
- Inserm (FR)
- Centre Hospitalier Métropole Savoie (FR)
- IC@dom SASU (France) (FR)
- Centre Hospitalier Annecy Genevois (FR)
- Corresponding author
- Borel, Anne-Laure
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2024-08-06
- Volume
- 47
- Issue
- 10
- Pages
- 1778-1786
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC11417293
- OpenAlex
- W4401362608
- Cited by
- 43
- References
- 31
- Citations by year
- 2026: 21 · 2025: 20 · 2024: 2
- FWCI
- 14.16
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Care (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- artificial pancreas, type 2 diabetes, continuous glucose monitoring, insulin pump therapy, glycemic control, time in range, insulin pump, sleep fragmentation, glycemic variability, glucose management indicator
- MeSH terms
- Aged, Blood Glucose, Diabetes Mellitus, Type 2, Female, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Middle Aged, Blood Glucose Self-Monitoring, Cross-Over Studies
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
