Evidence map›Paper›PMID 25034216›Full record

Trial reportBMC pediatrics2014

The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics.

Margaret L Lawson, Brenda Bradley, Karen McAssey, Cheril Clarson, Susan E Kirsch, Farid H Mahmud, Jacqueline R Curtis, Christine Richardson, Jennilea Courtney, Tammy Cooper and 5 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01295788 (Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
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.

NCT01295788 nacompletednot on this map

Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy

TypeinterventionalSponsorChildren's Hospital of Eastern OntarioRan2011 to 2017Enrolled144ConditionsType 1 DiabetesArmsSimultaneous RT-CGM and Pump Initiation, Delayed Initiation of RT-CGM
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Recruitment Into a Pediatric Continuous Glucose Monitoring RCT.Journal of diabetes science and technology · 2017
    Trial
  6. Review
  7. Review
  8. Review
  9. Article
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

15 authors at 8 institutions in 1 country.

Margaret L LawsonDivision of Endocrinology and Metabolism, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada. lawson@cheo.on.ca.
Brenda Bradley
Karen McAssey
Cheril Clarson
Susan E Kirsch
Farid H Mahmud
Jacqueline R Curtis
Christine Richardson
Jennilea Courtney
Tammy Cooper
Cynthia J Downie
Gopalan Rajamannar
Nicholas Barrowman
CGM TIME Trial Study Group
JDRF Canadian Clinical Trial Network CCTN1101
Agricultural Research Institute of Ontario · CAChildren's Hospital of Eastern Ontario · CAHospital for Sick Children · CARobarts Clinical Trials · CAJuvenile Diabetes Research Foundation · CALondon Health Sciences Centre · CAMarkham Stouffville Hospital · CAMcMaster Children's Hospital · CA

Funding

Yale University Clinical and Translational Science Award ProgramUL1TR000142 · NCATS · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2012 to 2015
$31.8M
NCATS NIH HHS UL1 TR000142
6 · The paper itself

Abstract

backgroundContinuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes. Effectiveness of CGM is directly linked with CGM adherence, which can be challenging to maintain in children and adolescents. We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation. METHODS/

designThe CGM TIME Trial is a multicenter randomized controlled trial. Eligible children and adolescents (5-18 years) with established type 1 diabetes were randomized to simultaneous initiation of pump (Medtronic Veo©) and CGM (Enlite©) or to standard pump therapy with delayed CGM introduction. Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation. Secondary outcomes include glycemic variability, stage of readiness, and other patient-reported outcomes with follow-up to 24 months. 144 (95%) of the 152 eligible patients were enrolled and randomized. Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference in CGM adherence and 86% power to detect a between group difference in hemoglobin A1C. Baseline characteristics were similar between the treatment groups. Analysis of 12 month primary outcomes will begin in September 2014. DISCUSSION: The CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation, readiness for behaviour change, and subsequent CGM adherence in pump naïve children and adolescents. Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes.

trial registrationClinicalTrial.gov NCT01295788. Registered 14 February 2011.

Indexed as

Insulin Infusion SystemsAdolescentBiomarkersBlood GlucoseBlood Glucose Self-MonitoringChildChild, PreschoolDiabetes Mellitus, Type 1FemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemic AgentsInfusion Pumps, ImplantableInsulinIntention to Treat AnalysisBiomarkersBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin

Identifiers

PMID25034216
PMCPMC4109785
OpenAlexW2091746134

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.