Evidence map›Paper›PMID 33606901›Full record

Trial reportDiabetes, obesity & metabolism2021

Hybrid closed-loop glucose control with faster insulin aspart compared with standard insulin aspart in adults with type 1 diabetes: A double-blind, multicentre, multinational, randomized, crossover study.

Charlotte K Boughton, Sara Hartnell, Hood Thabit, Tina Poettler, David Herzig, Malgorzata E Wilinska, Nicole L Ashcroft, Judy Sibayan, Nathan Cohen, Peter Calhoun and 5 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
10.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. The Future of Automated Insulin Delivery Systems.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2025
    Review
  12. Observational
  13. Review
  14. Review
  15. Review
  16. Article
  17. Real-World Evidence Analysis of a Hybrid Closed-Loop System.Journal of diabetes science and technology · 2025
    Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 6 institutions in 4 countries.

Charlotte K BoughtonWellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.ORCID 0000-0003-3272-9544
Sara HartnellWolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Hood ThabitDiabetes, Endocrinology and Metabolism Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Tina PoettlerDivision of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
David HerzigDepartment of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, Bern, Switzerland.ORCID 0000-0003-1028-9445
Malgorzata E WilinskaWellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.
Nicole L AshcroftWellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.
Judy SibayanJaeb Center for Health Research, Tampa, Florida, USA.
Nathan CohenJaeb Center for Health Research, Tampa, Florida, USA.
Peter CalhounJaeb Center for Health Research, Tampa, Florida, USA.ORCID 0000-0002-5325-7200
Lia BallyDepartment of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital, Bern, Switzerland.ORCID 0000-0003-1993-7672
Julia K MaderDivision of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Mark EvansWellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.ORCID 0000-0001-8122-8987
Lalantha LeelarathnaDiabetes, Endocrinology and Metabolism Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Roman HovorkaWellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, Cambridge, UK.
Cambridge University Hospitals NHS Foundation Trust · GBJaeb Center for Health Research · USWellcome/MRC Institute of Metabolic Science · GBManchester Academic Health Science Centre · GBMedical University of Graz · ATUniversity Hospital of Bern · CH

Funding

the European Union Horizon 2020 research and innovation programme 731560Wellcome TrustWellcome Trust 100574/Z/12/Z
6 · The paper itself

Abstract

aimTo evaluate the use of hybrid closed-loop glucose control with faster-acting insulin aspart (Fiasp) in adults with type 1 diabetes (T1D). RESEARCH DESIGN AND

methodsIn a double-blind, multinational, randomized, crossover study, 25 adults with T1D using insulin pump therapy (mean ± SD, age 38 ± 9 years, HbA1c 7.4% ± 0.8% [57 ± 8 mmol/mol]) underwent two 8-week periods of unrestricted living comparing hybrid closed-loop with Fiasp and hybrid closed-loop with standard insulin aspart in random order. During both interventions the CamAPS FX closed-loop system incorporating the Cambridge model predictive control algorithm was used.

resultsIn an intention-to-treat analysis, the proportion of time sensor glucose was in the target range (3.9-10.0 mmol/L; primary endpoint) was not different between interventions (75% ± 8% vs. 75% ± 8% for hybrid closed-loop with Fiasp vs. hybrid closed-loop with standard insulin aspart; mean-adjusted difference -0.6% [95% CI -1.8% to 0.7%]; p < .001 for non-inferiority [non-inferiority margin 5%]). The proportion of time with sensor glucose less than 3.9 mmol/L (median [IQR] 2.4% [1.2%-3.2%] vs. 2.9% [1.7%-4.0%]; p = .01) and less than 3.0 mmol/L (median [IQR] 0.4% [0.2%-0.7%] vs. 0.7% [0.2%-0.9%]; p = .03) was reduced with Fiasp versus standard insulin aspart. There was no difference in mean glucose (8.1 ± 0.8 vs. 8.0 ± 0.8 mmol/L; p = .13) or glucose variability (SD of sensor glucose 2.9 ± 0.5 vs. 2.9 ± 0.5 mmol/L; p = .90). Total daily insulin requirements did not differ (49 ± 15 vs. 49 ± 15 units/day; p = .45). No severe hypoglycaemia or ketoacidosis occurred.

conclusionsThe use of Fiasp in the CamAPS FX closed-loop system may reduce hypoglycaemia without compromising glucose control compared with standard insulin aspart in adults with T1D.

Indexed as

Diabetes Mellitus, Type 1Insulin AspartAdultBlood GlucoseCross-Over StudiesHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsMiddle AgedBlood GlucoseHypoglycemic AgentsInsulinInsulin Aspartartificial pancreasaspartclosed-loop insulin deliverycontinuous glucose monitoringfaster insulin aspartinsulin pump therapytype 1 diabetes

Identifiers

PMID33606901
PMCPMC11497277
OpenAlexW3131710019

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.