Evidence map›Paper›PMID 23359039›Full record

Trial reportCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2013

Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial.

Ahmad Haidar, Laurent Legault, Maryse Dallaire, Ammar Alkhateeb, Adèle Coriati, Virginie Messier, Peiyao Cheng, Maude Millette, Benoit Boulet, Rémi Rabasa-Lhoret

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

Trial report in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01297946 (An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Dual-hormone Closed-loop Strategy as Compared to Conventional CSII Therapy in Regulating Glucose Levels in Adults With Type-1 Diabetes in the Context of Exercise), which is not on this map. Cited by 64 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 3 pooled it
15.5field-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.

NCT01297946 phase1 / phase2completednot on this map

An Open-label, Randomized, Two-way, Cross-over Study to Assess the Efficacy of Dual-hormone Closed-loop Strategy as Compared to Conventional CSII Therapy in Regulating Glucose Levels in Adults With Type-1 Diabetes in the Context of Exercise

TypeinterventionalSponsorInstitut de Recherches Cliniques de MontrealEnrolled15ConditionsType 1 DiabetesArmsConventional continuous subcutaneous insulin infusion therapy, Dual-hormone closed-loop
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 3 syntheses or guidelines pooled it, 166 citations in OpenAlex.

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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 2 countries.

Ahmad HaidarInstitut de Recherches Cliniques de Montréal, Montréal, Que. ahmad.haidar@mail.mcgill
Laurent Legault
Maryse Dallaire
Ammar Alkhateeb
Adèle Coriati
Virginie Messier
Peiyao Cheng
Maude Millette
Benoit Boulet
Rémi Rabasa-Lhoret
Montreal Clinical Research Institute · CAMcGill University · CAIntelligent Machines (Sweden) · SEMontreal Children's Hospital · CAUniversité de Montréal · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost patients with type 1 diabetes do not achieve their glycemic targets. We aimed to assess the efficacy of glucose-responsive insulin and glucagon closed-loop delivery for controlling glucose levels in adults with type 1 diabetes.

methodsWe conducted a randomized crossover trial involving 15 adults with type 1 diabetes, comparing standard insulin-pump therapy with dual-hormone, closed-loop delivery. Patients were admitted twice to a clinical research facility and received, in random order, both treatments. Each 15-hour visit (from 1600 to 0700) included an evening exercise session, followed by a medium-sized meal, a bedtime snack and an overnight stay. During visits that involved closed-loop delivery, basal insulin and glucagon miniboluses were delivered according to recommendations based on glucose sensor readings and a predictive dosing algorithm at 10-minute intervals. During visits involving standard insulin-pump therapy (control visits), patients used conventional treatment.

resultsDual-hormone closed-loop delivery increased the percentage of time for which patients' plasma glucose levels were in the target range (median 70.7% [interquartile range (IQR) 46.1%-88.4%] for closed-loop delivery v. 57.3% [IQR 25.2%-71.8%] for control, p = 0.003) and decreased the percentage of time for which plasma glucose levels were in the low range (bottom of target range [< 4.0 mmol/L], 0.0% [IQR 0.0%-3.0%] for closed-loop delivery v. 10.2% [IQR 0.0%-13.0%] for control, p = 0.01; hypoglycemia threshold [< 3.3 mmol/L], 0.0% [IQR 0.0%-0.0%] for closed-loop delivery v. 2.8% [IQR 0.0%-5.9%] for control, p = 0.006). Eight participants (53%) had at least 1 hypoglycemic event (plasma glucose < 3.0 mmol/L) during standard treatment, compared with just 1 participant (7%) during closed-loop treatment (p = 0.02).

interpretationDual-hormone, closed-loop delivery guided by advanced algorithms improved short-term glucose control and reduced the risk of hypoglycemia in a group of 15 adults with type 1 diabetes.

trial registrationClinicalTrials.gov, no. NCT01297946.

Indexed as

Pancreas, ArtificialAdultAlgorithmsBiomarkersBlood GlucoseCross-Over StudiesDecision Support TechniquesDiabetes Mellitus, Type 1Drug Administration ScheduleDrug Therapy, CombinationFemaleGlucagonHumansHypoglycemiaHypoglycemic AgentsInfusion Pumps, ImplantableBiomarkersBlood GlucoseGlucagonHypoglycemic AgentsInsulin Aspart

Identifiers

PMID23359039
PMCPMC3589308
OpenAlexW2083628344

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.