Evidence map›Paper›PMID 23013201›Full record

ArticleDiabetes technology & therapeutics2012

Use of continuous glucose monitoring as an outcome measure in clinical trials.

Roy W Beck, Peter Calhoun, Craig Kollman

Registry-linked trialAbstract readComparative Study
In one paragraph

Article in Diabetes technology & therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07155993 (FastForward), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
1.9field-weighted citation impact, top 14% 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.

NCT07155993 enrolling by invitationnot on this mapstarted 2024, after this paper: background citation

FastForward: A Prospective Analysis of Long-term Fasting and Subsequent Food Reintroduction in Humans

Typeobservational_patient_registrySponsorBuchinger Wilhelmi Development & Holding GmbHRan2024 to 2026Enrolled300ConditionsDiabetes (DM), Pre Diabetes, Overweight (BMI &gt, 25)
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 59 citations in OpenAlex.

  1. Associations between HbADiabetic medicine : a journal of the British Diabetic Association · 2019
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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

3 authors at 1 institution in 1 country.

Roy W BeckJaeb Center for Health Research, Tampa, Florida, USA. jdrfapp@jaeb.org
Peter Calhoun
Craig Kollman
Jaeb Center for Health Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAlthough developed to be a management tool for individuals with diabetes, continuous glucose monitoring (CGM) also has potential value for the assessment of outcomes in clinical studies. We evaluated using CGM as such an outcome measure. RESEARCH DESIGN AND

methodsData were analyzed from six previously completed inpatient studies in which both CGM (Freestyle Navigator™ [Abbott Diabetes Care, Alameda, CA] or Guardian(®) [Medtronic, Northridge, CA]) and reference glucose measurements were available. The analyses included 97 days of data from 93 participants with type 1 diabetes (age range, 5-57 years; mean, 18 ± 12 years).

resultsMean glucose levels per day were similar for the CGM and reference measurements (median, 148 mg/dL vs. 143 mg/dL, respectively; P = 0.92), and the correlation of the two was high (r = 0.89). Similarly, most glycemia metrics showed no significant differences comparing CGM and reference values, except that the nadir glucose tended to be slightly lower and peak glucose slightly higher with reference measurements than CGM measurements (respective median, 59 mg/dL vs. 66 mg/dL [P = 0.05] and 262 mg/dL vs. 257 mg/dL [P = 0.003]) and glucose variability as measured with the coefficient of variation was slightly lower with CGM than reference measurements (respective median, 31% vs. 35%; P<0.001).

conclusionsA reasonably high degree of concordance exists when comparing outcomes based on CGM measurements with outcomes based on reference blood glucose measurements. CGM inaccuracy and underestimation of the extremes of hyperglycemia and hypoglycemia can be accounted for in a clinical trial's study design. Thus, in appropriate settings, CGM can be a very meaningful and feasible outcome measure for clinical trials.

Indexed as

Blood Glucose Self-MonitoringAdolescentAdultBlood GlucoseChildChild, PreschoolDiabetes Mellitus, Type 1FemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemiaMaleMiddle AgedOutcome Assessment, Health CareRandomized Controlled Trials as TopicBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, human

Identifiers

PMID23013201
PMCPMC3459006
OpenAlexW2020299096

What OpenQuestion 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 OpenQuestion graph.