Evidence map›Paper›PMID 29402319›Full record

ArticleTrials2018

Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial.

Melanie Schipfer, Carmen Albrecht, Dominic Ehrmann, Thomas Haak, Bernd Kulzer, Norbert Hermanns

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03175315 (Evaluation of a Newly Developed Psychoeducational Treatment and Education Program for People With Type 1 and Type 2 Diabetes on an Intensified Insulin Therapy Who Use Flash Glucose Monitoring), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
1.0field-weighted citation impact, top 23% 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.

NCT03175315 nacompletednot on this map

Evaluation of a Newly Developed Psychoeducational Treatment and Education Program for People With Type 1 and Type 2 Diabetes on an Intensified Insulin Therapy Who Use Flash Glucose Monitoring

TypeinterventionalSponsorNorbert HermannsRan2017 to 2018Enrolled216ConditionsDiabetes MellitusArmsTreatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 6 citations in OpenAlex.

No citing paper in PubMed yet.

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

6 authors at 1 institution in 1 country.

Melanie SchipferResearch Institute Diabetes Academy Bad Mergentheim (FIDAM GmbH), Johann-Hammer-Str. 24, 97980, Bad Mergentheim, Germany. schipfer@fidam.de.ORCID http://orcid.org/0000-0001-8870-5141
Carmen AlbrechtResearch Institute Diabetes Academy Bad Mergentheim (FIDAM GmbH), Johann-Hammer-Str. 24, 97980, Bad Mergentheim, Germany.
Dominic EhrmannResearch Institute Diabetes Academy Bad Mergentheim (FIDAM GmbH), Johann-Hammer-Str. 24, 97980, Bad Mergentheim, Germany.
Thomas HaakDiabetes Center Bad Mergentheim, Theodor-Klotzbücherstr. 12, 97980, Bad Mergentheim, Germany.
Bernd KulzerResearch Institute Diabetes Academy Bad Mergentheim (FIDAM GmbH), Johann-Hammer-Str. 24, 97980, Bad Mergentheim, Germany.
Norbert HermannsResearch Institute Diabetes Academy Bad Mergentheim (FIDAM GmbH), Johann-Hammer-Str. 24, 97980, Bad Mergentheim, Germany.
German Diabetes Center Mergentheim · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeople with diabetes on intensive insulin therapy need sufficient glycaemic control to prevent the onset or progression of diabetic complications. The burden of multiple daily blood glucose self-testing can be lessened by novel diabetes technology like flash glucose monitoring systems which provide more information compared to self-monitoring of blood glucose. Despite this delivered additional information studies are showing no significant effect on HbA METHODS/

designPatients are recruited through 40 diabetes outpatient study centres located across Germany. They will be randomly assigned to participate in the education and treatment programme (intervention group) or to obtain treatment as usual (control group). All patients have to give blood samples and to answer a bench of questionnaires during baseline assessment, at the end of the intervention, and 6 months after the end of the intervention. Physicians will be asked to declare some additional clinical data (such as details of the diabetes therapy) for every patient at every one of the three assessment points. DISCUSSION: This study is conducted as a randomised controlled trial to test the hypothesis that the newly developed education and treatment programme combined with the use of a flash glucose monitoring device (intervention group) is superior to reduce HbA

trial registrationClinicalTrials.gov, ID: NCT03175315 . Registered on 2 May 2017.

Indexed as

Patient Education as TopicAdolescentAdultAgedBiomarkersBlood GlucoseBlood Glucose Self-MonitoringDiabetes MellitusEquipment DesignFemaleGlycated HemoglobinHealth BehaviorHealth Knowledge, Attitudes, PracticeHumansHypoglycemic AgentsInsulinBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinDiabetesFlash glucose monitoringPatient education and treatment programmePatient-reported outcomePsychoeducationSelf-management

Identifiers

PMID29402319
PMCPMC5800040
OpenAlexW2785784942

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.