Evidence mapPaperPMID 36755913Full record

Trial reportFrontiers in endocrinology2023

Performance of a dual-hormone closed-loop system versus insulin-only closed-loop system in adolescents with type 1 diabetes. A single-blind, randomized, controlled, crossover trial.

Emilie Bundgaard Lindkvist, Christian Laugesen, Asbjørn Thode Reenberg, Tobias Kasper Skov Ritschel, Jannet Svensson, John Bagterp Jørgensen, Kirsten Nørgaard, Ajenthen G Ranjan

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in endocrinology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% 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.

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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Metabolic Models, in Silico Trials, and Algorithms.Journal of diabetes science and technology · 2025
    Review
  6. Metabolic Models, in Silico Trials, and Algorithms.Diabetes technology & therapeutics · 2025
    Review
  7. Dosing Algorithms for Insulin Pumps.Diabetes spectrum : a publication of the American Diabetes Association · 2025
    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

8 authors at 4 institutions in 1 country.

Emilie Bundgaard LindkvistCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
Christian LaugesenCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
Asbjørn Thode ReenbergDepartment of Applied Mathematics and Computer Science, Technical University of Denmark, Kgs. Lyngby, Denmark.
Tobias Kasper Skov RitschelDepartment of Applied Mathematics and Computer Science, Technical University of Denmark, Kgs. Lyngby, Denmark.
Jannet SvenssonCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
John Bagterp JørgensenDepartment of Applied Mathematics and Computer Science, Technical University of Denmark, Kgs. Lyngby, Denmark.
Kirsten NørgaardCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
Ajenthen G RanjanCopenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark.
Technical University of Denmark · DKCopenhagen University Hospital · DKUniversity of Copenhagen · DKDanish Diabetes Academy · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To assess the efficacy and safety of a dual-hormone (DH [insulin and glucagon]) closed-loop system compared to a single-hormone (SH [insulin only]) closed-loop system in adolescents with type 1 diabetes. Methods: This was a 26-hour, two-period, randomized, crossover, inpatient study involving 11 adolescents with type 1 diabetes (nine males [82%], mean ± SD age 14.8 ± 1.4 years, diabetes duration 5.7 ± 2.3 years). Except for the treatment configuration of the DiaCon Artificial Pancreas: DH or SH, experimental visits were identical consisting of: an overnight stay (10:00 pm until 7:30 am), several meals/snacks, and a 45-minute bout of moderate intensity continuous exercise. The primary endpoint was percentage of time spent with sensor glucose values below range (TBR [<3.9 mmol/L]) during closed-loop control over the 26-h period (5:00 pm, day 1 to 7:00 pm, day 2). Results: Overall, there were no differences between DH and SH for the following glycemic outcomes (median [IQR]): TBR 1.6 [0.0, 2.4] vs. 1.28 [0.16, 3.19]%, p=1.00; time in range (TIR [3.9-10.0 mmol/L]) 68.4 [48.7, 76.8] vs. 75.7 [69.8, 87.1]%, p=0.08; and time above range (TAR [>10.0 mmol/L]) 28.1 [18.1, 49.8] vs. 23.3 [12.3, 27.2]%, p=0.10. Mean ( ± SD) glucose was higher during DH than SH (8.7 ( ± 3.2) vs. 8.1 ( ± 3.0) mmol/L, p<0.001) but coefficient of variation was similar (34.8 ( ± 6.8) vs. 37.3 ( ± 8.6)%, p=0.20). The average amount of rescue carbohydrates was similar between DH and SH (6.8 ( ± 12.3) vs. 9.5 ( ± 15.4) grams/participant/visit, p=0.78). Overnight, TIR was higher, TAR was lower during the SH visit compared to DH. During and after exercise (4:30 pm until 7 pm) the SH configuration produced higher TIR, but similar TAR and TBR compared to the DH configuration. Conclusions: DH and SH performed similarly in adolescents with type 1 diabetes during a 26-hour inpatient monitoring period involving several metabolic challenges including feeding and exercise. However, during the night and around exercise, the SH configuration outperformed DH.

Indexed as

Diabetes Mellitus, Type 1InsulinAdolescentBlood GlucoseCross-Over StudiesFemaleGlucoseHumansMaleSingle-Blind MethodBlood GlucoseGlucoseInsulinadolescentsadvanced hybrid closed-loopartificial pancreasdual-hormonemoderate intensity continuous exercisenon-linear model predictive controltype 1 diabetes mellitus

Identifiers

PMID36755913
PMCPMC9899880
OpenAlexW4317717860

What Socratic holds

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LicenceCC BY
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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 Socratic graph.