학술논문
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.
Document Type
Academic Journal
Author
Reznik Y; Endocrinology and Diabetes Department, CHU Côte de Nacre, Caen Cedex, France and Unicaen, Caen Cedex, France.; Carvalho M; Diabetology Department, Vert Coteau Clinic, Marseille, France.; Fendri S; Diabetology Department, Amiens University Hospital, Amiens, France.; Prevost G; Normandie Univ, UNIROUEN, Inserm U1239, CHU Rouen, Department of Endocrinology, Diabetes and metabolic diseases and Inserm CIC-CRB 140, Rouen, France.; Chaillous L; Diabetology Department, Nantes University Hospital, Nantes, France.; Riveline JP; Centre Universitaire du diabète et de ses complications, APHP, Hôpital Lariboisière, Paris, Île-de-France, France and Institut Necker Enfants Malades, INSERM U1151, CNRS UMR 8253, IMMEDIAB Laboratory, Paris, France.; Hanaire H; Diabetology Department, Rangueil, Toulouse University Hospital, Toulouse, France.; Dubois S; Diabetology Department, Angers University Hospital, Angers, France.; Houéto P; Air Liquide Santé International, Paris, France.; Pasche H; Air Liquide Santé International, Paris, France.; Mianowska B; Department of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Lodz, Poland.; Renard E; Department of Endocrinology and Diabetes, Montpellier University Hospital, Montpellier, France and Institute of Functional Genomics, University of Montpellier, CNRS, INSERM, Montpellier, France.
Source
Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100883645 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1463-1326 (Electronic) Linking ISSN: 14628902 NLM ISO Abbreviation: Diabetes Obes Metab Subsets: MEDLINE
Subject
Language
English
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.
(© 2023 John Wiley & Sons Ltd.)
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.
(© 2023 John Wiley & Sons Ltd.)