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Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study

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Boughton, Charlotte K, Hartnell, Sara, Thabit, Hood, Mubita, Womba M, Draxlbauer, Katharine, Poettler, Tina, Wilinska, Malgorzata E, Hood, Korey K +5 more·2022·The Lancet Healthy Longevity
DOI 10.1016/s2666-7568(22)00005-8PMC PMC8967297
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Abstract

Background Older adults with type 1 diabetes have distinct characteristics that can make optimising glycaemic control challenging. We sought to test our hypothesis that hybrid closed-loop glucose control is safe and more effective than sensor-augmented pump (SAP) therapy in older adults with type 1 diabetes. Methods In an open-label, multicentre, multinational (UK and Austria), randomised, crossover study, adults aged 60 years and older with type 1 diabetes using insulin pump therapy underwent two 16-week periods comparing hybrid closed-loop (CamAPS FX, CamDiab, Cambridge, UK) and SAP therapy in random order. Block randomisation by means of central randomisation software to one of two treatment sequences was stratified by centre. The primary endpoint was the proportion of time sensor glucose was in target range between 3·9 and 10·0 mmol/L. Analysis for the primary endpoint and adverse events was by intention-to-treat. The study has completed and is registered at ClinicalTrials.gov NCT04025762. Findings 38 participants were enrolled. One participant withdrew during run-in because of difficulties with the study pump infusion sets. 37 participants (median [IQR] age 68 [63–70] years, mean [SD] baseline glycated haemoglobin [HbA 1c ]; 7·4% [0·9%]; 57 [10] mmol/mol) were randomly assigned between Sept 4, 2019, and Oct 2, 2020. The proportion of time with glucose between 3·9 and 10·0 mmol/L was significantly higher in the closed-loop group compared to the SAP group (79·9% [SD 7·9] vs 71·4% [13·2], difference 8·6 percentage points [95% CI 6·3 to 11·0]; p<0·0001). Two severe hypoglycaemia events occurred during the SAP period. There were two non-treatment related serious adverse events: cardiac arrest from pulmonary embolism associated with COVID-19 during the SAP period resulting in death, and a hospital presentation for parenteral hydrocortisone because of COVID-19 in a participant with adrenal insufficiency during the run-in period. Interpretation Hybrid closed-loop insulin delivery is safe and achieves superior glycaemic control to SAP therapy in older adults with long duration of type 1 diabetes. Importantly this was achieved without increasing the risk of hypoglycaemia in this population with risk factors for severe hypoglycaemia. This suggests that hybrid closed-loop therapy is a clinically important treatment option for older adults with type 1 diabetes. Funding National Institute of Diabetes and Digestive and Kidney Diseases.

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  • In contrast to the ORACL study, no significant differences in hypoglycemia were observed in the Boughton et al. trial.

    “In contrast to the ORACL study, no significant differences in hypoglycemia were observed.”

    From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [45]

  • Boughton et al. reported that hybrid closed-loop insulin delivery improved the proportion of time glucose was in range largely due to decreases in hyperglycemia.

    “They found that hybrid closedloop insulin delivery improved the proportion of time glucose was in range largely due to decreases in hyperglycemia.”

    From 13. Older Adults: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [45]

  • In contrast to the ORACL study, no significant differences in hypoglycemia were observed in the Boughton et al. trial.

    “In contrast to the ORACL study, no significant differences in hypoglycemia were observed.”

    From 13. Older Adults: Standards of Care in Diabetes—2025 (2025) · cites this paper as [48]

  • In a different open-label, crossover design clinical trial in 37 older adults (aged ≥60 years), 16 weeks of treatment with a hybrid closed-loop advanced insulin delivery system improved TIR and reduced time above range compared with sensor-augmented pump therapy; however, no significant differences in hypoglycemia were observed.

    “In a different open-label, crossover design clinical trial in 37 older adults (aged ≥60 years), 16 weeks of treatment with a hybrid closed-loop advanced insulin delivery system improved TIR and reduced time above range compared with sensor-augmented pump therapy; however, in contrast to the ORACL study, no significant differences in hypoglycemia were observed (53).”

    From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [53]

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Authors
Boughton, C. K., Hartnell, S., Thabit, H., Mubita, W. M., Draxlbauer, K., Poettler, T., Wilinska, M. E., Hood, K. K., Mader, J. K., Narendran, P., Leelarathna, L., Evans, M. L., & Hovorka, R.
Affiliations
  • Cambridge University Hospitals NHS Foundation Trust (GB)
  • Manchester Academic Health Science Centre (GB)
  • University Hospitals Birmingham NHS Foundation Trust (GB)
  • Medical University of Graz (AT)
  • Wellcome/MRC Institute of Metabolic Science (GB)
  • Stanford Medicine (US)
Corresponding author
Boughton, Charlotte K
ORCID
Venue
The Lancet Healthy Longevity
Publisher
Elsevier BV
Published
2022-03
Volume
3
Issue
3
Pages
e135-e142
ISSN
2666-7568 (ISSN-L)
DOI
10.1016/s2666-7568(22)00005-8
PMC
PMC8967297
OpenAlex
W4221125458
Cited by
127
References
21
Citations by year
2026: 25 · 2025: 37 · 2024: 29 · 2023: 25 · 2022: 11
FWCI
18.90
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet Healthy Longevity (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion, cc-by-nc-nd)
  • Research Explorer (The University of Manchester) (submittedVersion)
  • Apollo (University of Cambridge) (submittedVersion, cc-by)
  • Apollo (University of Cambridge) (submittedVersion, cc-by-nc-nd)
  • Apollo (cc-by)
  • Apollo
Funders
  • National Institute for Health and Care Research
  • Eli Lilly and Company
  • Juvenile Diabetes Research Foundation United Kingdom
  • National Institute of Diabetes and Digestive and Kidney Diseases (1DP3DK112176-01)
  • Wellcome Trust
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
Keywords
hybrid closed-loop insulin delivery, sensor-augmented pump therapy, type 1 diabetes, older adults, glycemic control, time in range, hypoglycemia, insulin pump therapy, COVID-19 pandemic, adrenal insufficiency, HbA1c, adverse events, cortisol, pulmonary embolism
MeSH terms
COVID-19, Aged, Blood Glucose, Diabetes Mellitus, Type 1, Glucose, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Middle Aged, Treatment Outcome, Cross-Over Studies

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