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Cited by 68Diabetes Management and ResearchDiabetes Management and EducationDiabetes and associated disorders

Hybrid Closed-Loop Control Is Safe and Effective for People with Type 1 Diabetes Who Are at Moderate to High Risk for Hypoglycemia

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Anderson, Stacey M., Buckingham, Bruce A., Breton, Marc D., Robic, Jessica L., Barnett, Charlotte L., Wakeman, Christian A., Oliveri, Mary C., Brown, Sue A. +8 more·2019·Diabetes Technology & Therapeutics
DOI 10.1089/dia.2019.0018PMC PMC6551970
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Abstract

Background: Typically, closed-loop control (CLC) studies excluded patients with significant hypoglycemia. We evaluated the effectiveness of hybrid CLC (HCLC) versus sensor-augmented pump (SAP) in reducing hypoglycemia in this high-risk population. Methods: Forty-four subjects with type 1 diabetes, 25 women, 37 ± 2 years old, HbA1c 7.4% ± 0.2% (57 ± 1.5 mmol/mol), diabetes duration 19 ± 2 years, on insulin pump, were enrolled at the University of Virginia ( N = 33) and Stanford University ( N = 11). Eligibility: increased risk of hypoglycemia confirmed by 1 week of blinded continuous glucose monitor (CGM); randomized to 4 weeks of home use of either HCLC or SAP. Primary/secondary outcomes: risk for hypoglycemia measured by the low blood glucose index (LBGI)/CGM-based time in ranges. Results: Values reported: mean ± standard deviation. From baseline to the final week of study: LBGI decreased more on HCLC (2.51 ± 1.17 to 1.28 ± 0.5) than on SAP (2.1 ± 1.05 to 1.79 ± 0.98), P < 0.001; percent time below 70 mg/dL (3.9 mmol/L) decreased on HCLC (7.2% ± 5.3% to 2.0% ± 1.4%) but not on SAP (5.8% ± 4.7% to 4.8% ± 4.5%), P = 0.001; percent time within the target range 70–180 mg/dL (3.9–10 mmol/L) increased on HCLC (67.8% ± 13.5% to 78.2% ± 10%) but decreased on SAP (65.6% ± 12.9% to 59.6% ± 16.5%), P < 0.001; percent time above 180 mg/dL (10 mmol/L) decreased on HCLC (25.1% ± 15.3% to 19.8% ± 10.1%) but increased on SAP (28.6% ± 14.6% to 35.6% ± 17.6%), P = 0.009. Mean glucose did not change significantly on HCLC (144.9 ± 27.9 to 143.8 ± 14.4 mg/dL [8.1 ± 1.6 to 8.0 ± 0.8 mmol/L]) or SAP (152.5 ± 24.3 to 162.4 ± 28.2 [8.5 ± 1.4 to 9.0 ± 1.6]), P = ns. Conclusions: Compared with SAP therapy, HCLC reduced the risk and frequency of hypoglycemia, while improving time in target range and reducing hyperglycemia in people at moderate to high risk of hypoglycemia.

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  • DiAs was successfully used in high-risk patients, i.e., those who experienced frequent hypoglycemia or had hypoglycemia unawareness or history of severe hypoglycemia.

    “(2) a successful use of AID in high-risk patients, ie, those who experienced frequent hypoglycemia or had hypoglycemia unawareness or history of severe hypoglycemia, 127”

    From Developing the UVA/Padova Type 1 Diabetes Simulator: Modeling, Validation, Refinements, and Utility (2023) · cites this paper as [127]

    The System components section identifies DiAs as the platform used for the closed-loop system, and the Primary outcomes section reports a significantly greater reduction in hypoglycemia risk with that system than with the control treatment. The Eligibility criteria include hypoglycemia risk and unawareness, but exclude severe hypoglycemia in the preceding three months; our copy does not establish a history of severe hypoglycemia among participants. It also says the final two experimental subjects used inControl instead of DiAs. (LLM, conf=0.87)

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  1. [9]9. with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care 2016;39:1168-1174.

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Authors
Anderson, S. M., Buckingham, B. A., Breton, M. D., Robic, J. L., Barnett, C. L., Wakeman, C. A., Oliveri, M. C., Brown, S. A., Ly, T. T., Clinton, P. K., Hsu, L. J., Kingman, R. S., Norlander, L. M., Loebner, S. E., Reuschel-DiVirglio, S., & Kovatchev, B. P.
Affiliations
  • University of Virginia (US)
  • Stanford Medicine (US)
Corresponding author
Anderson, Stacey M.
ORCID
Venue
Diabetes Technology & Therapeutics
Publisher
SAGE Publications
Published
2019-05-22
Volume
21
Issue
6
Pages
356-363
ISSN
  • 1520-9156 (ISSN-L)
  • 1557-8593
DOI
10.1089/dia.2019.0018
PMC
PMC6551970
OpenAlex
W2946360926
Cited by
68
References
22
Citations by year
2026: 2 · 2025: 8 · 2024: 10 · 2023: 13 · 2022: 8 · 2021: 11 · 2020: 10 · 2019: 5 · 2018: 1
FWCI
6.90
Type
journal article
Language
en
Open access
Licence
journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations
  • Diabetes Technology & Therapeutics (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Roche Diabetes Care
  • National Institutes of Health
  • National Institute of Diabetes and Digestive and Kidney Diseases (DP3DK101055)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
type 1 diabetes, hypoglycemia, sensor-augmented pump, continuous glucose monitoring, low blood glucose index, time in range, glycemic variability, insulin pump therapy, glycemic control, hypoglycemia risk reduction
MeSH terms
Adult, Blood Glucose, Diabetes Mellitus, Type 1, Equipment Design, Female, Humans, Hyperglycemia, Hypoglycemia, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Male, Blood Glucose Self-Monitoring

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