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Cited by 276Diabetes Management and ResearchDiabetes Management and EducationDiabetes and associated disorders

Improved glycemic outcomes with Medtronic MiniMed advanced hybrid closed-loop delivery: results from a randomized crossover trial comparing automated insulin delivery with predictive low glucose suspend in people with type 1 diabetes

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Collyns, Olivia J., Meier, Renee A., Betts, Zara L., Chan, Denis S.H., Frampton, Chris, Frewen, Carla M., Hewapathirana, Niranjala M., Jones, Shirley D. +7 more·2021·Diabetes Care
DOI 10.2337/dc20-2250
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Abstract

OBJECTIVE: To study the MiniMed Advanced Hybrid Closed-Loop (AHCL) system, which includes an algorithm with individualized basal target set points, automated correction bolus function, and improved Auto Mode stability. RESEARCH DESIGN AND METHODS: This dual-center, randomized, open-label, two-sequence crossover study in automated-insulin-delivery–naive participants with type 1 diabetes (aged 7–80 years) compared AHCL to sensor-augmented pump therapy with predictive low glucose management (SAP + PLGM). Each study phase was 4 weeks, preceded by a 2- to 4-week run-in and separated by a 2-week washout. RESULTS: The study was completed by 59 of 60 people (mean age 23.3 ± 14.4 years). Time in target range (TIR) 3.9–10 mmol/L (70–180 mg/dL) favored AHCL over SAP + PLGM (70.4 ± 8.1% vs. 57.9 ± 11.7%) by 12.5 ± 8.5% (P < 0.001), with greater improvement overnight (18.8 ± 12.9%, P < 0.001). All age-groups (children [7–13 years], adolescents [14–21 years], and adults [>22 years]) demonstrated improvement, with adolescents showing the largest improvement (14.4 ± 8.4%). Mean sensor glucose (SG) at run-in was 9.3 ± 0.9 mmol/L (167 ± 16.2 mg/dL) and improved with AHCL (8.5 ± 0.7 mmol/L [153 ± 12.6 mg/dL], P < 0.001), but deteriorated during PLGM (9.5 ± 1.1 mmol/L [17 ± 19.8 mg/dL], P < 0.001). TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared with 6.7 mmol/L (120 mg/dL), 72.0 ± 7.9% vs. 64.6 ± 6.9%, respectively, with no additional hypoglycemia. Auto Mode was active 96.4 ± 4.0% of the time. The percentage of hypoglycemia at baseline (<3.9 mmol/L [70 mg/dL] and ≤3.0 mmol/L [54 mg/dL]) was 3.1 ± 2.1% and 0.5 ± 0.6%, respectively. During AHCL, the percentage time at <3.9 mmol/L (70 mg/dL) improved to 2.1 ± 1.4% (P = 0.034) and was statistically but not clinically reduced for ≤3.0 mmol/L (54 mg/dL) (0.5 ± 0.5%; P = 0.025). There was one episode of mild diabetic ketoacidosis attributed to an infusion set failure in combination with an intercurrent illness, which occurred during the SAP + PLGM arm. CONCLUSIONS: AHCL with automated correction bolus demonstrated significant improvement in glucose control compared with SAP + PLGM. A lower algorithm SG set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.

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  • Evidence suggests that an AID hybrid closed-loop system is superior to AID sensor-augmented pump therapy for increased percentage of time in range and reduction of hypoglycemia.

    “Evidence suggests that an AID hybrid closed-loop system is superior to AID sensor-augmented pump therapy for increased percentage of time in range and reduction of hypoglycemia (34,35).”

    From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [35]

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Authors
Collyns, O. J., Meier, R. A., Betts, Z. L., Chan, D. S. H., Frampton, C., Frewen, C. M., Hewapathirana, N. M., Jones, S. D., Roy, A., Grosman, B., Kurtz, N., Shin, J., Vigersky, R. A., Wheeler, B. J., & de Bock, M. I.
Affiliations
  • Canterbury District Health Board (NZ)
  • Christchurch Clinical Studies Trust (NZ)
  • Southern District Health Board (NZ)
  • University of Otago (NZ)
  • Medtronic, Northridge, CA
  • Canterbury District Health Board, Christchurch, New Zealand
ORCID
Venue
Diabetes Care
Publisher
American Diabetes Association
Published
2021-02-12
Volume
44
Issue
4
Pages
969-975
ISSN
  • 0149-5992 (ISSN-L)
  • 1935-5548
DOI
10.2337/dc20-2250
OpenAlex
W3129111678
Cited by
276
References
22
Citations by year
2026: 25 · 2025: 38 · 2024: 57 · 2023: 63 · 2022: 54 · 2021: 38
FWCI
39.57
Type
journal article
Language
en
Open access
Licence
www.diabetesjournals.org/content/license (vor, 35 d)
Locations
  • Diabetes Care (publishedVersion)
  • PubMed (publishedVersion)
Funders
Medtronic
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, hybrid closed-loop insulin delivery, artificial pancreas, predictive low glucose suspend, sensor-augmented pump therapy, time in range, glycemic variability, children and adolescents, insulin pump therapy, continuous glucose monitoring, hypoglycemia
MeSH terms
Adolescent, Adult, Blood Glucose, Child, Diabetes Mellitus, Type 1, Glucose, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Cross-Over Studies, Young Adult

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