Should people with type 2 diabetes treated by multiple daily insulin injections with home health care support be switched to hybrid closed‐loop? The CLOSE AP + randomized controlled trial
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Aim: The study aim was to evaluate the feasibility, safety and efficacy of automated insulin delivery (AID) assisted by home health care (HHC) services in people with type 2 diabetes unable to manage multiple daily insulin injections (MDI) at home on their own. Patients and Methods: This was an open label, multicentre, randomized, parallel group trial. In total, 30 adults with type 2 diabetes using MDI and requiring nursing support were randomly allocated to AID or kept their usual therapy over a 12‐week period. Both treatments were managed with the support of HHC services. The primary outcome was the percentage time in the target glucose range of 70‐180 mg/dl (TIR). Secondary outcomes included other continuous glucose monitoring metrics, glycated haemoglobin (HbA1c) levels, daily insulin doses, body weight, and of quality of life scores, fear of hypoglycaemia and satisfaction questionnaires. Results: Age (69.7 vs. 69.3 years) and HbA1c (9.25 vs. 9.0) did not differ in MDI and AID at baseline. Compared with MDI, AID resulted in a significant increase in TIR by 27.4% [95% CI (15.0‐39.8); p < .001], a decrease in time above range by 27.7% and an unchanged time below range of <1%. A between‐group difference in HbA1c was 1.3% favouring AID. Neither severe hypoglycaemia nor ketoacidosis occurred in either group. Patient and caregiver satisfaction with AID was high. Conclusions: AID combined with tailored HHC services significantly improved glycaemic control with no safety issues in people with type 2 diabetes previously under an MDI regimen with HHC. AID should be considered a safe option in these people when lacking acceptable glucose control.
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A recent randomized controlled trial of older adults with type 2 diabetes using multiple daily injections who were unable to manage insulin therapy on their own revealed an increase of time in range of 27% over 12 weeks of AID use in addition to tailored home health care services.
“A recent randomized controlled trial of older adults with type 2 diabetes using multiple daily injections who were unable to manage insulin therapy on their own revealed an increase of TIR of 27% over 12 weeks of AID use in addition to tailored home health care services (49).”
From 13. Older Adults: Standards of Care in Diabetes—2025 (2025) · cites this paper as [49]
A later RCT of older adults with type 2 diabetes using multiple daily injections who were unable to manage insulin therapy on their own demonstrated an increase of TIR of 27% over 12 weeks of AID use in addition to tailored home health care services.
“A later RCT of older adults with type 2 diabetes using multiple daily injections who were unable to manage insulin therapy on their own demonstrated an increase of TIR of 27% over 12 weeks of AID use in addition to tailored home health care services (54).”
From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [54]
Other studies showed nonsignificant trends for lower total daily insulin dose in AID group.
“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 [250]
A recent RCT of older adults with type 2 diabetes using MDI but unable to manage insulin on their own showed TIR increase of 27% over 12 weeks of AID plus tailored home health care.
“Finally, a recent RCT of older adults with type 2 diabetes who used MDI but were unable to manage insulin therapy on their own revealed an increase of TIR of 27% over 12 weeks of AID system use in addition to tailored home health care services (250).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [250]
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- Authors
- Reznik, Y., Carvalho, M., Fendri, S., Prevost, G., Chaillous, L., Riveline, J. P., Hanaire, H., Dubois, S., Houéto, P., Pasche, H., Mianowska, B., & Renard, E.
- Affiliations
- Centre Hospitalier Universitaire de Caen Normandie (FR)
- Diabetology Department Vert Coteau Clinic Marseille France
- Centre Hospitalier Universitaire Amiens-Picardie (FR)
- Normandie Univ, UNIROUEN, Inserm U1239, CHU Rouen, Department of Endocrinology Diabetes and metabolic diseases and Inserm CIC‐CRB 140 Rouen France
- Centre Hospitalier Universitaire de Nantes (FR)
- Hôpital Necker-Enfants Malades (FR)
- Centre Hospitalier Universitaire de Toulouse (FR)
- Diabetology Department Angers University Hospital Angers France
- Air Liquide (France) (FR)
- Medical University of Lodz (PL)
- Department of Endocrinology and Diabetes, Montpellier University Hospital, Montpellier, France and Institute of Functional Genomics University of Montpellier, CNRS, INSERM Montpellier France
- Corresponding author
- Reznik, Yves
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2023-11-03
- Volume
- 26
- Issue
- 2
- Pages
- 622-630
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W4388293974
- Cited by
- 34
- References
- 32
- Citations by year
- 2026: 11 · 2025: 15 · 2024: 8
- FWCI
- 6.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Obesity and Metabolism (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Funders
- H2020 European Institute of Innovation and Technology
- 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
- type 2 diabetes, multiple daily insulin injections, artificial pancreas, hybrid closed-loop insulin pump, home health care, glycemic control, time in range, HbA1c, hypoglycemia, patient satisfaction, nursing support
- MeSH terms
- Adult, Blood Glucose, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Home Care Services, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Quality of Life, Blood Glucose Self-Monitoring, Treatment Outcome, Insulin, Regular, Human
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