Evidence map›Paper›PMID 23033237›Full record

Trial reportDiabetes care2013

Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial.

Andrew Dauber, Liat Corcia, Jason Safer, Michael S D Agus, Sara Einis, Garry M Steil

3 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 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.

NCT01421225 nacompletednot on this map

Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age

TypeinterventionalSponsorBoston Children's HospitalRan2011 to 2013Enrolled10ConditionsType 1 Diabetes MellitusArmsClosed-loop Insulin Pump therapy, Standard Insulin Pump Therapy
NCT02299479 nacompletednot on this mapstarted 2015, after this paper: background citation

Adjusting Insulin Delivery to Activity (AIDA)

TypeinterventionalSponsorBoston Children's HospitalRan2015 to 2017Enrolled20ConditionsDiabetes, Nocturnal HypoglycemiaArmsDexcom G4 Platinum CGM, Activity monitor
NCT02657083 nacompletednot on this mapstarted 2016, after this paper: background citation

Prevention of Hypoglycemia After Exercise Using DreaMed Substance Administration Device in Children and Adolescents With Type 1 Diabetes (The PHYSI-DREAM Study)

TypeinterventionalSponsorUniversity of Ljubljana, Faculty of MedicineRan2016 to 2016Enrolled20ConditionsType 1 Diabetes MellitusArmsDreaMed Substance Administration Device, Sensor Augmented Pump (SAP)
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  16. Artificial Pancreas in Young Children.Diabetes technology & therapeutics · 2017
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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

6 authors.

Andrew DauberDivision of Endocrinology, Boston Children’s Hospital, Boston, MA, USA.
Liat Corcia
Jason Safer
Michael S D Agus
Sara Einis
Garry M Steil

Funding

HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
NCRR NIH HHS UL1 RR 025758NCRR NIH HHS UL1 RR025758
6 · The paper itself

Abstract

objectiveTo assess the possibility of improving nocturnal glycemic control as well as meal glycemic response using closed-loop therapy in children aged <7 years. RESEARCH DESIGN AND

methodsThis was a randomized controlled crossover trial comparing closed-loop with standard open-loop insulin pump therapy performed in an inpatient clinical research center. Ten subjects aged <7 years with type 1 diabetes for >6 months treated with insulin pump therapy were studied. Closed-loop therapy and standard open-loop therapy were compared from 10:00 p.m. to 12:00 p.m. on 2 consecutive days. The primary outcome was plasma glucose time in range (110-200 mg/dL) during the night (10:00 p.m.-8:00 a.m.). Secondary outcomes included peak postprandial glucose levels, incidence of hypoglycemia, degree of hyperglycemia, and prelunch glucose levels.

resultsA trend toward a higher mean nocturnal time within target range was noted for closed- versus open-loop therapy, although not reaching statistical significance (5.3 vs. 3.2 h, P = 0.12). There was no difference in peak postprandial glucose or number of episodes of hypoglycemia. There was significant improvement in time spent >300 mg/dL overnight with closed-loop therapy (0.18 vs. 1.3 h, P = 0.035) and the total area under the curve of glucose >200 mg/dL (P = 0.049). Closed-loop therapy returned prelunch blood glucose closer to target (189 vs. 273 mg/dL on open loop, P = 0.009).

conclusionsClosed-loop insulin delivery decreases the severity of overnight hyperglycemia without increasing the incidence of hypoglycemia. The therapy is better able to reestablish target glucose levels in advance of a subsequent meal. Younger children with type 1 diabetes may reap significant benefits from closed-loop therapy.

Indexed as

Blood GlucoseChildChild, PreschoolFemaleHumansHyperglycemiaInsulinMaleBlood GlucoseInsulin

Identifiers

PMID23033237
PMCPMC3554296

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.