Evidence map›Paper›PMID 37037948›Full record

Trial reportDiabetologia2023

Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial.

Christian Laugesen, Ajenthen G Ranjan, Signe Schmidt, Kirsten Nørgaard

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Diabetologia, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04764968 (Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.0field-weighted citation impact, top 22% 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.

NCT04764968 phase2completednot on this map

Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes: A Randomized, Open-Label, Two-Period Crossover Outpatient Study

TypeinterventionalSponsorSteno Diabetes Center CopenhagenRan2021 to 2022Enrolled24ConditionsType 1 Diabetes, HypoglycemiaArmsDasiglucagon
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. 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

4 authors at 2 institutions in 1 country.

Christian LaugesenClinical Research, Steno Diabetes Center Copenhagen, Herlev, Denmark. christian.laugesen@regionh.dk.ORCID https://orcid.org/0000-0001-9253-9457
Ajenthen G RanjanClinical Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.ORCID https://orcid.org/0000-0002-2253-6071
Signe SchmidtClinical Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.ORCID https://orcid.org/0000-0002-6968-6675
Kirsten NørgaardClinical Research, Steno Diabetes Center Copenhagen, Herlev, Denmark.ORCID https://orcid.org/0000-0003-1620-8271
Steno Diabetes Centers · DKUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aims/hypothesisConsumption of excess carbohydrates to manage hypoglycaemia can lead to rebound hyperglycaemia and promote weight gain. The objective of this trial was to evaluate the efficacy, safety and feasibility of pen-administered low-dose dasiglucagon for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions.

methodsTwenty-four adults with insulin pump-treated type 1 diabetes (HbA

resultsCompared with usual care, the mean difference (95% CI) in the DASI period for time in (3.9-10.0 mmol/l) and below (<3.9 mmol/l) range was 2.4 %-points (-0.7, 5.5) and -0.5 %-points (-1.2, 0.2), respectively. In the DASI period, recovery rate (time from hypoglycaemia treatment to euglycaemia) was 44% (11, 87) faster while total daily carbohydrate intake was reduced by 11% (-18, -3). Dasiglucagon use was safe and well tolerated with mild nausea being the most frequent adverse effect. Among the participants, 96% (p<0.0001) were likely to include dasiglucagon in their future routine management of hypoglycaemia. CONCLUSIONS/

interpretationUse of low-dose dasiglucagon to prevent and treat non-severe hypoglycaemia during free-living conditions was safe, fast and efficacious while significantly reducing the total daily carbohydrate intake and yielding high treatment satisfaction.

trial registrationClinicalTrials.gov NCT04764968

fundingThe study was an investigator-initiated trial. Zealand Pharma supplied the investigational drug and device and provided financial support for the conduct of the trial.

Indexed as

Diabetes Mellitus, Type 1HypoglycemiaAdultBlood GlucoseBlood Glucose Self-MonitoringCross-Over StudiesGlucagonHumansHypoglycemic AgentsInsulinBlood GlucosedasiglucagonGlucagonHypoglycemic AgentsInsulinDasiglucagonDual-hormone therapyHypoglycaemiaPhase 2Randomised controlled trialType 1 diabetes

Identifiers

PMID37037948
PMCPMC10244275
OpenAlexW4363679527

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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.