Evidence map›Paper›PMID 27612500›Full record

Trial reportDiabetes care2016

Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial.

Martin Tauschmann, Janet M Allen, Malgorzata E Wilinska, Hood Thabit, Carlo L Acerini, David B Dunger, Roman Hovorka

5 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 40 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 6 pooled it
9.9field-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.

NCT01873066 nacompletednot on this map

An Open-label, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy, Safety and Utility of Automated Closed-loop Glucose Control, Day and Night Over 7 Days (Phase 1) and 21 Days (Phase 2) in Comparison With Continuous Subcutaneous Insulin Infusion Combined With Continuous Glucose Monitoring in the Home Setting in Children and Adolescents T1D

TypeinterventionalSponsorUniversity of CambridgeRan2014 to 2016Enrolled24ConditionsDiabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System DiseasesArmsClosed-loop system, real-time CGM
NCT03101865 nacompletednot on this mapstarted 2017, after this paper: background citation

An Open-label, Multi-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of Closed Loop Insulin Delivery Using Diluted Insulin in Comparison With Closed Loop With Non-diluted Insulin Over 21 Days in Children With Type 1 Diabetes Aged 1 to 7 Years in the Home Setting

TypeinterventionalSponsorUniversity of CambridgeRan2017 to 2018Enrolled24ConditionsType 1 Diabetes MellitusArmsFlorenceM
NCT03755479 completednot on this mapstarted 2019, after this paper: background citation

Evaluation of Minimed 670G Hybrid Closed Loop System On-Boarding Protocol, for Patients With Type 1 Diabetes on Multiple Daily Insulin Injection Therapy

TypeobservationalSponsorSidra MedicineRan2019 to 2019Enrolled30ConditionsDiabetes Mellitus, Type 1ArmsHybrid Closed Loop Insulin Pump Minimed 670G
NCT03784027 nacompletednot on this mapstarted 2019, after this paper: background citation

Open-label, Multi-centre, Multi-national, Randomized 2-period Crossover Study Comparing Closed-loop Insulin Delivery With Sensor-augmented Pump Therapy Over 4 Months in Children 1-7 Years With Type 1 Diabetes at Home, With an Extension.

TypeinterventionalSponsorUniversity of CambridgeRan2019 to 2022Enrolled81ConditionsType 1 Diabetes MellitusArmsCamAPS FX, Sensor augmented therapy
NCT04759144 nacompletednot on this mapstarted 2021, after this paper: background citation

A Randomised Crossover Study Comparing Hybrid Closed-loop Insulin Delivery Using Ultra-rapid Acting Insulin to Hybrid Closed-loop Insulin Delivery Using Standard Rapid-acting Insulin in Children With Type 1 Diabetes in the Home Setting (FAST-Kids)

TypeinterventionalSponsorUniversity of CambridgeRan2021 to 2022Enrolled27ConditionsType 1 Diabetes MellitusArmsCamAPS FX using faster insulin aspart, CamAPS FX using standard insulin aspart
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 6 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Early Stages of Automated Insulin Delivery.Diabetes technology & therapeutics · 2025
    Review
  9. Early Stages of Automated Insulin Delivery.Journal of diabetes science and technology · 2025
    Review
  10. Article
  11. Experiences of People With Type 1 Diabetes Using the iLet Bionic Pancreas in Primary Care: A Qualitative Analysis.Clinical diabetes : a publication of the American Diabetes Association · 2025
    Article
  12. Article
  13. Review
  14. A Systematic Review of Commercial Hybrid Closed-Loop Automated Insulin Delivery Systems.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023 · on this map
    Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Recent advances in closed-loop insulin delivery.Metabolism: clinical and experimental · 2022
    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

7 authors at 1 institution in 1 country.

Martin TauschmannWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
Janet M AllenWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
Malgorzata E WilinskaWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
Hood ThabitWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
Carlo L AceriniDepartment of Paediatrics, University of Cambridge, Cambridge, U.K.
David B DungerWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
Roman HovorkaWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, U.K. rh347@cam.ac.uk.
University of Cambridge · GB

Funding

Home testing of 24/7 closed-loop control in children and adolescents with type 1R01DK085621 · NIDDK · UNIVERSITY OF CAMBRIDGE · PI HOVORKA, ROMAN · 2009 to 2010
$748k
NIDDK NIH HHS R01 DK085621Wellcome Trust
6 · The paper itself

Abstract

objectiveThis study evaluated the feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions. RESEARCH DESIGN AND

methodsIn an open-label randomized crossover study, 12 suboptimally controlled adolescents on insulin pump therapy (mean ± SD age 14.6 ± 3.1 years; HbA

resultsThe proportion of time that sensor glucose was in the target range (3.9-10 mmol/L; primary end point) was increased during the closed-loop intervention compared with sensor-augmented insulin pump therapy by 18.8 ± 9.8 percentage points (mean ± SD; P < 0.001), the mean sensor glucose level was reduced by 1.8 ± 1.3 mmol/L (P = 0.001), and the time spent above target was reduced by 19.3 ± 11.3 percentage points (P < 0.001). The time spent with sensor glucose levels below 3.9 mmol/L was low and comparable between interventions (median difference 0.4 [interquartile range -2.2 to 1.3] percentage points; P = 0.33). Improved glucose control during closed-loop was associated with increased variability of basal insulin delivery (P < 0.001) and an increase in the total daily insulin dose (53.5 [39.5-72.1] vs. 51.5 [37.6-64.3] units/day; P = 0.006). Participants expressed positive attitudes and experience with the closed-loop system.

conclusionsFree-living home use of day-and-night closed-loop in suboptimally controlled adolescents with type 1 diabetes is safe, feasible, and improves glucose control without increasing the risk of hypoglycemia. Larger and longer studies are warranted.

Indexed as

AdolescentBlood GlucoseChildC-PeptideCross-Over StudiesDiabetes Mellitus, Type 1FemaleGlycated HemoglobinHumansInsulinMaleSurveys and QuestionnairesTime FactorsTreatment OutcomeUrinalysisBlood GlucoseC-PeptideGlycated HemoglobinInsulin

Identifiers

PMID27612500
PMCPMC5079605
OpenAlexW2508578552

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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 Socratic graph.