Evidence mapPaperPMID 39497517Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2025

Sensor-derived glycaemic metrics in pregnant women with type 1 diabetes randomised to faster acting insulin aspart or insulin aspart-A secondary analysis of the CopenFast trial.

Julie C Søholm, Sidse K Nørgaard, Kirsten Nørgaard, Tine D Clausen, Peter Damm, Elisabeth R Mathiesen, Lene Ringholm

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
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.

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

3 citing papers in PubMed.

  1. Trial
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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

7 authors.

Julie C SøholmCenter for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-4936-8936
Sidse K NørgaardCenter for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-6664-5755
Kirsten NørgaardDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-1620-8271
Tine D ClausenCenter for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-5585-2153
Peter DammCenter for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-2067-5246
Elisabeth R MathiesenCenter for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-3279-0863
Lene RingholmCenter for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-2971-8043

Funding

Novo Nordisk A/S
6 · The paper itself

Abstract

aimsWe compared sensor-derived glycaemic metrics in pregnant women with type 1 diabetes (T1D) randomised to faster acting insulin aspart (faster aspart) or insulin aspart (IAsp).

methodsA pre-planned secondary analysis of the CopenFast trial included women with T1D using intermittently scanned continuous glucose monitoring (isCGM) during pregnancy. Glycaemic metrics, including time in range (TIRp, 3.5-7.8 mmol/L) and time below range in pregnancy (TBRp, <3.5 mmol/L), were evaluated in the intervals: from randomisation (median 9.5 weeks, interquartile range 9.0-11.0) to 21 weeks, from 22 to 33 weeks and from 34 to 37 weeks.

resultsIn total, 113 (91%) of 124 women using isCGM in the original trial were included. At randomisation, glycaemic metrics were comparable in both groups. Women randomised to faster aspart achieved higher TIRp from 22 to 33 weeks (estimated treatment difference 5.1% [95% confidence interval 0.3; 9.7], p = 0.04) and mean TIRp >70% from randomisation to 21 weeks onwards, while this was achieved after 34 weeks in women randomised to IAsp. TBRp remained stable around 4% throughout pregnancy in both groups. One (2%) versus 5 (9%) experienced ≥1 severe hypoglycaemic event (odds ratio 0.93 [-0.2; -0.01], p = 0.04). Infant birthweight standard deviation score was lower in the faster aspart group (estimated treatment difference -0.5 [-0.9; -0.03], p = 0.04); however, this attenuated when adjusting for parity (p = 0.10).

conclusionsWomen using faster aspart achieved more TIRp and experienced less severe hypoglycaemia compared to women using IAsp. Infant birthweight was lower and thereby more appropriate in the faster aspart group; however, this attenuated when adjusting for parity.

Indexed as

Blood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Hypoglycemic AgentsInsulin AspartPregnancy in DiabeticsAdultFemaleGlycated HemoglobinGlycemic ControlHumansHypoglycemiaPregnancyBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulin Aspartcontinuous glucose monitoringhypoglycaemiapregnancytype 1 diabetes

Identifiers

PMID39497517
PMCPMC11635549

What Socratic holds

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Registered trials

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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.