Evidence map›Paper›PMID 36920756›Full record

Trial reportThe New England journal of medicine2023

Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes.

R Paul Wadwa, Zachariah W Reed, Bruce A Buckingham, Mark D DeBoer, Laya Ekhlaspour, Gregory P Forlenza, Melissa Schoelwer, John Lum, Craig Kollman, Roy W Beck and 2 more

2 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 79 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 7 pooled it
30.4field-weighted citation impact, top 1% 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.

NCT04796779 nacompletednot on this map

The Pediatric Artificial Pancreas (PEDAP) Trial: A Randomized Controlled Comparison of the Control-IQ Technology Versus Standard of Care in Young Children in Type 1 Diabetes

TypeinterventionalSponsorMarc BretonRan2021 to 2022Enrolled102ConditionsType 1 DiabetesArmsTandem t:slim X2 with Control-IQ Technology Pro, Standard Care (SC), Tandem t:slim X2 with Control-IQ Technology V1.5
NCT06021119 phase3completednot on this map

Feasibility of DPP-4 Inhibitor for the Treatment of Iftar-Related Glycemic Excursions in Patients With Type 1 Diabetes on MiniMed™ 780G Advanced Hybrid Closed Loop System

TypeinterventionalSponsorAin Shams UniversityRan2023 to 2023Enrolled50ConditionsTime in RangeArmsDipeptidyl peptidase-4 inhibitors
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 7 syntheses or guidelines pooled it, 151 citations in OpenAlex.

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  4. Real-World Evidence of Automated Insulin Delivery System Use.Diabetes technology & therapeutics · 2024
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19 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

R Paul WadwaFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).ORCID 0000-0002-4139-2122
Zachariah W ReedFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
Bruce A BuckinghamFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
Mark D DeBoerFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
Laya EkhlaspourFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
Gregory P ForlenzaFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
Melissa SchoelwerFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
John LumFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
Craig KollmanFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
Roy W BeckFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
Marc D BretonFrom the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
PEDAP Trial Study Group
Jaeb Center for Health Research · USUniversity of Virginia · USUniversity of Colorado Anschutz Medical Campus · USStanford University · USUniversity of California, San Francisco · US

Funding

NIDDK NIH HHS U01 DK127551NIDDK NIH HHS U01DK127551
6 · The paper itself

Abstract

backgroundClosed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear.

methodsIn this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. Secondary outcomes included the percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes.

resultsA total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group); the glycated hemoglobin levels at baseline ranged from 5.2 to 11.5%. Initiation of the closed-loop system was virtual in 55 patients (81%). The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during the 13-week follow-up period in the closed-loop group and from 54.9±14.7% to 55.9±12.6% in the standard-care group (mean adjusted difference, 12.4 percentage points [equivalent to approximately 3 hours per day]; 95% confidence interval, 9.5 to 15.3; P<0.001). We observed similar treatment effects (favoring the closed-loop system) on the percentage of time that the glucose level was above 250 mg per deciliter, on the mean glucose level, and on the glycated hemoglobin level, with no significant between-group difference in the percentage of time that the glucose level was below 70 mg per deciliter. There were two cases of severe hypoglycemia in the closed-loop group and one case in the standard-care group. One case of diabetic ketoacidosis occurred in the closed-loop group.

conclusionsIn this trial involving young children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with standard care. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; PEDAP ClinicalTrials.gov number, NCT04796779.).

Indexed as

Blood GlucoseDiabetes Mellitus, Type 1Hypoglycemic AgentsInsulinInsulin Infusion SystemsBlood Glucose Self-MonitoringChildChild, PreschoolGlycated HemoglobinHumansBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin

Identifiers

PMID36920756
PMCPMC10082994
OpenAlexW4324305901

What Socratic 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 Socratic graph.