Hybrid Closed-Loop Therapy in Adults With Type 1 Diabetes and Above-Target HbA1c: A Real-world Observational Study

Abstract

OBJECTIVE We explored longitudinal changes associated with switching to hybrid closed loop (HCL) insulin delivery systems in adults with type 1 diabetes and elevated HbA1c levels despite the use of intermittently scanned continuous glucose monitoring (isCGM) and insulin pump therapy. RESEARCH DESIGN AND METHODS We undertook a pragmatic, preplanned observational study of participants included in the National Health Service England closed loop pilot. Adults using isCGM and insulin pump across 31 diabetes centers in England with an HbA1c ≥8.5% who were willing to commence HCL therapy were included. Outcomes included change in HbA1c, sensor glucometrics, diabetes distress score, Gold score (hypoglycemia awareness), acute event rates, and user opinion of HCL. RESULTS In total, 570 HCL users were included (median age 40 [IQR 29–50] years, 67% female, and 85% White). Mean baseline HbA1c was 9.4 ± 0.9% (78.9 ± 9.1 mmol/mol) with a median follow-up of 5.1 (IQR 3.9–6.6) months. Of 520 users continuing HCL at follow-up, mean adjusted HbA1c reduced by 1.7% (95% CI 1.5, 1.8; P < 0.0001) (18.1 mmol/mol [95% CI 16.6, 19.6]; P < 0.0001). Time in range (70–180 mg/dL) increased from 34.2 to 61.9% (P < 0.001). Individuals with HbA1c of ≤58 mmol/mol rose from 0 to 39.4% (P < 0.0001), and those achieving ≥70% glucose time in range and <4% time below range increased from 0.8 to 28.2% (P < 0.0001). Almost all participants rated HCL therapy as having a positive impact on quality of life (94.7% [540 of 570]). CONCLUSIONS Use of HCL is associated with improvements in HbA1c, time in range, hypoglycemia, and diabetes-related distress and quality of life in people with type 1 diabetes in the real world.

Automated closed-loop insulin delivery for the management of type 1 diabetes during pregnancy: the AiDAPT RCT

“…20,[25][26][27] A real-world observational study involving 520 adults (median age 40 years) from 31 NHS diabetes clinics in England reported large glycaemic benefits in those who were willing to continue using a hybrid closed-loop system. 28 Participants in this study had higher baseline HbA1c (mean 79 mmol/mol or 9.4%) than those in randomised trials and were all experienced insulin pump users. They were also switched from intermittently scanned (flash) glucose monitoring, meaning that the impact of using real-time CGM and hybrid closed-loop systems may have both contributed to the positive study outcomes.…”

“…They were also switched from intermittently scanned (flash) glucose monitoring, meaning that the impact of using real-time CGM and hybrid closed-loop systems may have both contributed to the positive study outcomes. 28 These improvements in glucose and patient-reported outcomes were generalisable across the different hybrid closed-loop systems used [including Medtronic 780G (MiniMed, Inc., Minneapolis, MN, USA), Tandem Control IQ (Tandem Diabetes Care, Inc., San Diego, CA, USA) and CamAPS ® FX (CamDiab Ltd, Cambridge, UK)].…”

Artificial pancreases for type 1 diabetes: Better access is “watershed moment”—but delivery is key

“…NICE’s decision was aided by real world data from a large scale NHS pilot of the technology, funded by NHS England 45. The data showed that in adults and in children the technology led to markedly better glucose control, reduced risk of hypoglycaemia and its long term complications, and improvements in quality of life measures such as the quality of sleep.…”

The role of automated insulin delivery technology in diabetes

“…An NHS England pilot study evaluating real-world implementation of hybrid closed-loop technology included 251 children and 570 adults with type 1 diabetes [41,42]. Of 226 children and young people with complete data at 6 months, HbA 1c was reduced by 0.7 percentage points and time in target glucose range (3.9 to 10.0 mmol/l) increased from 49% to 63%.…”