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
Year: 2023
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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.
Source: Diabetes Obesity and Metabolism
DOI: 10.1111/dom.15351
Institutions: Centre Hospitalier Universitaire de Caen Normandie, Université de Caen Normandie, Centre Hospitalier Universitaire Amiens-Picardie, Inserm, Université de Rouen Normandie, Centre Hospitalier Universitaire de Nantes, Nantes Université, Hôpital Necker-Enfants Malades, Centre National de la Recherche Scientifique, Institut Necker Enfants Malades, Assistance Publique – Hôpitaux de Paris, Hôpital Lariboisière, Centre Hospitalier Universitaire de Toulouse, Hôpital Rangueil, Centre Hospitalier Universitaire d'Angers, Air Liquide (France), Medical University of Lodz, Université de Montpellier, Centre Hospitalier Universitaire de Montpellier, Institut de Génomique Fonctionnelle
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4388293974