Evidence map›Paper›PMID 33453783›Full record

Trial reportLancet (London, England)2021

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.

Richard M Bergenstal, Revital Nimri, Roy W Beck, Amy Criego, Lori Laffel, Desmond Schatz, Tadej Battelino, Thomas Danne, Stuart A Weinzimer, Judy Sibayan and 13 more

4 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 141 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
141citing papers in PubMed, 6 pooled it
39.3field-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.

NCT05069727 nacompletednot on this map

Evaluation of Two Levels of Health Care Interactions in Adolescents With Type 1 Diabetes on Advanced Hybrid Closed Loop System MiniMed 780G/ Zeus Sensor

TypeinterventionalSponsorSidra MedicineRan2021 to 2022Enrolled34ConditionsDiabetes type1ArmsRegular Protocol with advanced carbohydrate counting, Simplified Protocol with fixed carbohydrate content
NCT05924932 unknown statusnot on this mapstarted 2022, after this paper: background citation

Effect of an Artificial Pancreas System on Glycemic Control in Patients With Type 1 Diabetes

TypeobservationalSponsorMasaryk Hospital Usti nad LabemRan2022 to 2024Enrolled120ConditionsDiabetes Mellitus, Type 1ArmsTandem t:slim X2 with hybrid closed loop system Control IQ, glucose sensor: Dexcom G6, MiniMed 780G, with hybrid closed loop system SmartGuard, sensor Guardien 4
NCT06115460 phase3completednot on this mapstarted 2022, after this paper: background citation

The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Type 1 Diabetes Mellitus and Diabetic Nephropathy

TypeinterventionalSponsorAin Shams UniversityRan2022 to 2023Enrolled46ConditionsType 1 Diabetic NephropathyArmsoral sitagliptin supplementation
NCT06466967 completednot on this mapstarted 2024, after this paper: background citation

Clinical Utility of a Tight Glucose Objectives Through Advanced Hybrid Closed-loop Systems in Adult Patients With Type 1 Diabetes and Poor Glycemic Control

Typeobservational_patient_registrySponsorCastilla-La Mancha Health ServiceRan2024 to 2026Enrolled40ConditionsType 1 DiabetesArmsAdvanced hybrid closed-loop CamAPS FX
3 · Its place in the literature

Who cites it

141 citing papers in PubMed, 6 syntheses or guidelines pooled it, 319 citations in OpenAlex.

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81 more citing papers are in PubMed but not listed here.

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

23 authors at 11 institutions in 4 countries.

Richard M BergenstalInternational Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA. Electronic address: richard.bergenstal@parknicollet.com.
Revital NimriSchneider Children's Medical Center, Petah Tikva, Israel.
Roy W BeckJaeb Center for Health Research Foundation, Tampa, FL, USA.
Amy CriegoInternational Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA.
Lori LaffelJoslin Diabetes Center, Harvard Medical School, Boston, MA, USA.
Desmond SchatzDepartment of Pediatrics, University of Florida College of Medicine, Gainesville, FL, USA.
Tadej BattelinoUniversity Medical Center Ljubljana, University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Thomas DanneAuf der Bult Centre for Children and Adolescents, Diabetology, Endocrinology and General Paediatrics, Hannover, Germany.
Stuart A WeinzimerDepartment of Pediatrics, Yale University, New Haven, CT, USA.
Judy SibayanJaeb Center for Health Research Foundation, Tampa, FL, USA.
Mary L JohnsonInternational Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA.
Ryan J BaileyJaeb Center for Health Research Foundation, Tampa, FL, USA.
Peter CalhounJaeb Center for Health Research Foundation, Tampa, FL, USA.
Anders CarlsonInternational Diabetes Center, HealthPartners Institute, Minneapolis, MN, USA.
Elvira IsganaitisJoslin Diabetes Center, Harvard Medical School, Boston, MA, USA.
Rachel BelloSchneider Children's Medical Center, Petah Tikva, Israel.
Anastasia Albanese-O'NeillDepartment of Pediatrics, University of Florida College of Medicine, Gainesville, FL, USA.
Klemen DovcUniversity Medical Center Ljubljana, University Children's Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Torben BiesterAuf der Bult Centre for Children and Adolescents, Diabetology, Endocrinology and General Paediatrics, Hannover, Germany.
Kate WeymanDepartment of Pediatrics, Yale University, New Haven, CT, USA.
Korey HoodStanford University School of Medicine, Stanford Diabetes Research Center, Palo Alto, CA, USA.
Moshe PhillipSchneider Children's Medical Center, Petah Tikva, Israel.
FLAIR Study Group
HealthPartners · USJaeb Center for Health Research · USSchneider Children's Medical Center · ILFlorida College · USKinderkrankenhaus auf der Bult · DEYale University · USHarvard University · USJoslin Diabetes Center · USLjubljana University Medical Centre · SIStanford University · USUniversity of Ljubljana · SI

Funding

SPECIAL ASSAY COREP30DK036836 · NIDDK · JOSLIN DIABETES CENTER · PI ROHIT N. KULKARNI · 1986 to 2026
$50.5M
Home Use of MD-Logic Automated Insulin Delivery System: Safety and EfficacyUC4DK108611 · NIDDK · HEALTHPARTNERS INSTITUTE · PI BERGENSTAL, RICHARD MAURITZ, PHILLIP, MOSHE · 2015 to 2016
$8.9M
NIDDK NIH HHS P30 DK036836NIDDK NIH HHS UC4 DK108611
6 · The paper itself

Abstract

backgroundManagement of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes.

methodsIn this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14-29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA

findingsBetween June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (>10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -3·00% [95% CI -3·97 to -2·04]; p<0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (<3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -0·06% [95% CI -0·11 to -0·02]; p<0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group.

interpretationHyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology

fundingNational Institute of Diabetes and Digestive and Kidney Diseases.

Indexed as

Insulin Infusion SystemsAdultBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1FemaleGermanyHumansHyperglycemiaInsulinIsraelMaleUnited StatesYoung AdultInsulin

Identifiers

PMID33453783
PMCPMC9194961
OpenAlexW3118986275

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.