Evidence map›Paper›PMID 30119757›Full record

Trial reportThe Lancet. Child & adolescent health2018

Efficacy of the Flexible Lifestyles Empowering Change intervention on metabolic and psychosocial outcomes in adolescents with type 1 diabetes (FLEX): a randomised controlled trial.

Elizabeth J Mayer-Davis, David M Maahs, Michael Seid, Jamie Crandell, Franziska K Bishop, Kimberly A Driscoll, Christine M Hunter, Jessica C Kichler, Debra Standiford, Joan M Thomas and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Lancet. Child & adolescent health, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05147324 (Individualized Planned Eating Patterns to Improve Glycemic Management in Adolescents With Type 1 Diabetes), which is not on this map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
4.1field-weighted citation impact, top 5% 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.

NCT05147324 nacompletednot on this mapstarted 2021, after this paper: background citation

Individualized Planned Eating Patterns to Improve Glycemic Management in Adolescents With Type 1 Diabetes: A Pilot Clinical Trial

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2021 to 2023Enrolled52ConditionsType 1 DiabetesArms"MyPlan" - Individualized Planned Eating Pattern
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 56 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Elizabeth J Mayer-DavisDepartments of Nutrition and Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: ejmayer-davis@unc.edu.
David M MaahsDepartment of Pediatrics, School of Medicine, Stanford University, Stanford, CA, USA.
Michael SeidCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, Cincinnati, OH, USA.
Jamie CrandellSchool of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Franziska K BishopBarbara Davis Center for Childhood Diabetes, University of Colorado Denver, Denver, CO, USA.
Kimberly A DriscollBarbara Davis Center for Childhood Diabetes, University of Colorado Denver, Denver, CO, USA.
Christine M HunterNational Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.
Jessica C KichlerCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, Cincinnati, OH, USA.
Debra StandifordCincinnati Children's Hospital Medical Center, University of Cincinnati Medical School, Cincinnati, OH, USA.
Joan M ThomasDepartments of Nutrition and Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
FLEX Study Group
University of North Carolina at Chapel Hill · USCincinnati Children's Hospital Medical Center · USUniversity of Colorado Denver · USUniversity of Cincinnati · USNational Institute of Diabetes and Digestive and Kidney Diseases · USStanford University · US

Funding

UNIV OF NORTH CAROLINA CLINICAL NUTRITION RESEARCH UNITP30DK056350 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Ian Michael Carroll · 1999 to 2026
$31.6M
Stanford Islet Research CoreP30DK116074 · NIDDK · STANFORD UNIVERSITY · PI Seung K Kim · 2017 to 2026
$19.5M
FL3X: An Adaptive Intervention to Improve Outcomes for Youth with Type 1 DiabetesUC4DK101132 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MAAHS, DAVID MATTHEW, MAYER-DAVIS, ELIZABETH J · 2013 to 2013
$6.9M
NIDDK NIH HHS P30 DK056350NIDDK NIH HHS P30 DK116074NIDDK NIH HHS UC4 DK101132
6 · The paper itself

Abstract

backgroundAdolescents with type 1 diabetes commonly have poor glycaemic control. We aimed to test the efficacy of a newly developed adaptive behavioral intervention (Flexible Lifestyles Empowering Change; FLEX) on metabolic and psychosocial outcomes in adolescents with type 1 diabetes.

methodsYoung people (13-16 years, type 1 diabetes duration >1 year, HbA

findingsYoung people recruited from May 1, 2014 to April 4, 2016 were randomly assigned to FLEX (n=130) or usual care control (n=128). Mean diabetes duration was 6·4 (SD 3·8) years, and 71% (181 out of 256) of patients used insulin pump therapy. Retention was 93%, with 241 out of 258 completing the 18-month assessment. The intervention fidelity score was 4·40 of 5·00 for motivational interviewing and 97% for session content. At 18 months, HbA

interpretationThe FLEX intervention did not significantly change HbA

fundingNational Institutes of Health and National Institute of Diabetes Digestive Diseases and Kidney and the Helmsley Charitable Trust.

Indexed as

Life StylePower, PsychologicalAdolescentDiabetes Mellitus, Type 1FemaleHumansMaleTreatment Outcome

Identifiers

PMID30119757
PMCPMC6260973
OpenAlexW2887931512

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.