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 - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Diabetes, Obesity and Metabolism Année : 2024

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

Résumé

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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Dates et versions

hal-04284019 , version 1 (14-11-2023)

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Citer

Yves Reznik, Martin Carvalho, Salha Fendri, Gaetan Prevost, Lucy Chaillous, et al.. 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. Diabetes, Obesity and Metabolism, 2024, 26 (2), pp.622-630. ⟨10.1111/dom.15351⟩. ⟨hal-04284019⟩
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