Evidence map›Paper›PMID 33863716›Full record

ArticleBMJ open diabetes research & care2021

Therapy adjustments in people with type 1 diabetes with impaired hypoglycemia awareness on multiple daily injections using real-time continuous glucose monitoring: a mechanistic analysis of the HypoDE study.

Delia Waldenmaier, Guido Freckmann, Stefan Pleus, Norbert Hermanns, Dominic Ehrmann, Lutz Heinemann, Cornelia Haug

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in BMJ open diabetes research & care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02671968 (Real-Time Continuous Glucose Monitoring), 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
1.3field-weighted citation impact, top 19% 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.

NCT02671968 nacompletednot on this map

Real-Time Continuous Glucose Monitoring (RT-CGM) in Patients With Type 1 Diabetes at High Risk for Low Glucose Values Using Multiple Daily Injections (MDI) in Germany (HYPODE-STUDY)

TypeinterventionalSponsorScience Consulting in DiabetesRan2016 to 2017Enrolled141ConditionsDiabetesArmsContinuous Glucose Monitoring System
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 9 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

7 authors at 2 institutions in 1 country.

Delia WaldenmaierInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany delia.waldenmaier@idt-ulm.de.ORCID 0000-0003-3280-2369
Guido FreckmannInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0002-0406-9529
Stefan PleusInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0003-4629-7754
Norbert HermannsResearch Institute of the Diabetes Academy Mergentheim, Bad Mergentheim, Germany.
Dominic EhrmannResearch Institute of the Diabetes Academy Mergentheim, Bad Mergentheim, Germany.
Lutz HeinemannScience-Consulting in Diabetes, Neuss, Germany.
Cornelia HaugInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Universität Ulm · DEGerman Diabetes Center Mergentheim · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionStudies have shown beneficial effects of real-time continuous glucose monitoring (rtCGM) usage on clinical outcomes. The objective of this analysis was to identify which therapy adjustments were made by people with type 1 diabetes with impaired hypoglycemia awareness during rtCGM usage enabling reductions in the number of low glucose events observed in the HypoDE (Hypoglycemia in Deutschland) study. RESEARCH DESIGN AND

methodsIn the multicenter randomized controlled trial in people with type 1 diabetes on multiple daily injections with impaired hypoglycemia awareness, participants recorded their diabetes therapy in 7-day logbooks at baseline and at 6-month follow-up. They used rtCGM or self-monitoring of blood glucose for therapy adjustments. This mechanistic analysis looked at changes in various aspects of therapy.

resultsLogbooks were completed by 70 participants in the rtCGM group and 65 participants in the control group. Participants in the rtCGM group kept their total carbohydrate consumption, daily insulin doses and distribution constant during the study. However, they reported an increased intake of rescue carbohydrates (0.8±0.6 (mean±SD) vs 1.0±0.8 intake/day; baseline-adjusted between-group difference 0.3 intake (0.1-0.5), p=0.031). The glucose threshold at which rescue carbohydrate intake was initiated was elevated from 71±13 mg/dL (3.9±0.7 mmol/L) to 79±14 mg/dL (4.4±0.8 mmol/L) (adjusted between-group difference +7.6 mg/dL (2.4-12.8) (+0.4 mmol/L (0.1-0.7)); p=0.005) in the rtCGM group. Regression analysis showed that follow-up low glucose events were associated with group allocation (p<0.001), low glucose events at baseline (p=0.016) and rescue threshold (p=0.001).

conclusionsNo major adjustments in insulin therapy were made by study participants with impaired hypoglycemia awareness; however, they were more active in preventing hypoglycemia by taking rescue carbohydrates earlier and more often. TRIAL REGISTRATION NUMBER: NCT02671968.

Indexed as

Diabetes Mellitus, Type 1HypoglycemiaBlood GlucoseBlood Glucose Self-MonitoringHumansHypoglycemic AgentsBlood GlucoseHypoglycemic Agentsdiethypoglycemiainsulin

Identifiers

PMID33863716
PMCPMC8055114
OpenAlexW3152503026

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.