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
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.
CONFLICT OF INTEREST STATEMENT
YR declares consultant/speaker fees from Medtronic, Insulet, Embecta, Abbott, Novo Nordisk, Eli-Lilly, Sanofi, TIMKL and Air Liquide Santé International. MC declares consultant/speaker fees from Dinno Santé, Orkyn, LVL, Médical, D Medica, Diabsante, Elivie, Homeperf, D Team Diabète, Mellitus Care, Medtronic, Novo Nordisk, Lilly, Sanofi and AstraZeneca. SF has received scientific advisor fees from Abbott Diabetes Care, Air Liquide Santé International, Eli-Lilly, Novo Nordisk, Orkyn, Sanofi and VitalAire. GP declares consultant/speaker fees from Abbott, Amgen, AstraZeneca, Dexcom, BMS, Boehringer-Ingelheim, Lilly, Medtronic, MSD, Novo Nordisk and Sanofi. LC declares consultant/speaker fees from Air Liquide Santé International, Asten Santé, VitalAire, Lilly, Medtronic, Novo Nordisk and Sanofi. JPR is an advisory panel member for Sanofi, MSD, Eli-Lilly, Novo Nordisk, AstraZeneca, Abbott, Dexcom, Alphadiab, Air Liquide and Medtronic and has received research funding and provided research support to Abbott, Air Liquide, Sanofi and Novo Nordisk. HH has received lecturer and scientific advisor fees from Insulet, Abbott, AstraZeneca, Novo Nordisk, Lilly, Sanofi, Lifescan, Medtronic, and research grants from Novo Nordisk, Lifescan, Abbott and Sanofi. SD is a scientific expert for AstraZeneca, Medtronic, Novo Nordisk and TIMKL. PH and HP are shareholders in Air Liquide and are employed by Air Liquide Santé International. BM in relation to this research received support from the European Institute of Innovation and Technology (EIT Health) project CLOSE (Automated Glucose Control at Home for People with Chronic Disease) financed within the European Union's Horizon 2020 program and declares consultant/speaker fees from Abbott, Air Liquide Santé International, Dexcom/Proglikemia, Medtronic and Ypsomed. ER declares consultant/speaker fees from A. Menarini Diagnostics, Abbott, Air Liquide Santé International, AstraZeneca, Becton-Dickinson, Boehringer-Ingelheim, Cellnovo, Dexcom Inc., Eli-Lilly, Hillo, Insulet Inc., Johnson & Johnson (Animas, LifeScan), Medtronic, Medirio, Novo Nordisk, Roche and Sanofi-Aventis and research support by Abbott, Dexcom Inc., Insulet Inc., Roche and Tandem Diabetes Care.
Open Research
PEER REVIEW
The peer review history for this article is available at https://www.webofscience.com/api/gateway/wos/peer-review/10.1111/dom.15351.
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
