Evidence map›Paper›PMID 30352896›Full record

ArticleDiabetes care2019

Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.

Roy W Beck, Richard M Bergenstal, Tonya D Riddlesworth, Craig Kollman, Zhaomian Li, Adam S Brown, Kelly L Close

Abstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 389 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
389citing papers in PubMed, 14 pooled it
–field-weighted citation impact
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

389 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  11. Real-World Evidence of Automated Insulin Delivery System Use.Diabetes technology & therapeutics · 2024
    Pooled it
  12. Guideline
  13. Guideline
  14. Once-Weekly Insulin IcodecArchives of endocrinology and metabolism · 2023
    Pooled it
  15. Trial
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329 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Roy W BeckJaeb Center for Health Research, Tampa, FL rbeck@jaeb.org.ORCID 0000-0002-5194-8446
Richard M BergenstalInternational Diabetes Center Park Nicollet, Minneapolis, MN.ORCID 0000-0002-9050-5584
Tonya D RiddlesworthJaeb Center for Health Research, Tampa, FL.ORCID 0000-0003-4545-1668
Craig KollmanJaeb Center for Health Research, Tampa, FL.
Zhaomian LiJaeb Center for Health Research, Tampa, FL.
Adam S BrownClose Concerns, San Francisco, CA.
Kelly L CloseThe diaTribe Foundation, San Francisco, CA.

Funding

Training Program in Bioinformatics and Integrative GenomicsT32HG002295 · NHGRI · MASSACHUSETTS INSTITUTE OF TECHNOLOGY · PI Peter J Park · 2001 to 2026
$15.8M
NHGRI NIH HHS T32 HG002295
6 · The paper itself

Abstract

objectiveThis study evaluated the association of time in range (TIR) of 70-180 mg/dL (3.9-10 mmol/L) with the development or progression of retinopathy and development of microalbuminuria using the Diabetes Control and Complications Trial (DCCT) data set in order to validate the use of TIR as an outcome measure for clinical trials. RESEARCH DESIGN AND

methodsIn the DCCT, blood glucose concentrations were measured at a central laboratory from seven fingerstick samples (seven-point testing: pre- and 90-min postmeals and at bedtime) collected during 1 day every 3 months. Retinopathy progression was assessed every 6 months and urinary microalbuminuria development every 12 months. Proportional hazards models were used to assess the association of TIR and other glycemic metrics, computed from the seven-point fingerstick data, with the rate of development of microvascular complications.

resultsMean TIR of seven-point profiles for the 1,440 participants was 41 ± 16%. The hazard rate of development of retinopathy progression was increased by 64% (95% CI 51-78), and development of the microalbuminuria outcome was increased by 40% (95% CI 25-56), for each 10 percentage points lower TIR (

conclusionsBased on these results, a compelling case can be made that TIR is strongly associated with the risk of microvascular complications and should be an acceptable end point for clinical trials. Although hemoglobin A

Indexed as

Clinical Trials as TopicOutcome Assessment, Health CareAdultBlood GlucoseBlood Glucose Self-MonitoringDiabetes ComplicationsDiabetes MellitusDisease ProgressionFemaleGlycated HemoglobinHumansLongitudinal StudiesMaleMiddle AgedPatient Care PlanningPrognosisBlood GlucoseGlycated Hemoglobin

Identifiers

PMID30352896
PMCPMC6905478

What OpenQuestion holds

Textmetadata
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.