Evidence map›Paper›PMID 36602040›Full record

ArticleJournal of diabetes science and technology2024

Evaluation of a Digital Health Tool for Titration of Basal Insulin in People With Type 2 Diabetes: Rationale and Design of a Randomized Controlled Trial.

Norbert Hermanns, Dominic Ehrmann, Katharina Finke-Gröne, Timm Roos, Guido Freckmann, Bernhard Kulzer

Abstract readClinical Trial Protocol
In one paragraph

Article in Journal of diabetes science and technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

6 authors.

Norbert HermannsResearch Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany.ORCID 0000-0002-2903-2677
Dominic EhrmannResearch Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany.
Katharina Finke-GröneResearch Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany.
Timm RoosResearch Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany.
Guido FreckmannForschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Institut für Diabetes-Technologie, Ulm, Germany.ORCID 0000-0002-0406-9529
Bernhard KulzerResearch Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOptimal insulin titration is essential in helping people with type 2 diabetes mellitus (T2DM) to achieve adequate glycemic control. Barriers of people with diabetes to implementation of titration include lack of self-efficiency and self-management skills, increased diabetes-related distress, low treatment satisfaction, poor well-being, as well as concerns about hypoglycemia and insulin overdose. My Dose Coach is a digital health tool for optimizing titration of basal insulin that combines a smartphone app for patients with T2DM and a Web portal for healthcare professionals. METHODS/

designThis is a prospective, open-label, multicenter, randomized controlled parallel study conducted in approximately 50 centers in Germany that are specialized in the treatment of diabetes. Patients in the intervention group will use the titration app and will be registered on the Web portal by their treating physician. Control group patients will continue their current basal insulin titration without using the app. The primary outcome is the mean change in HbA1c levels at the 12-week follow-up. The secondary outcome measures include patient-reported outcomes such as diabetes-related distress, self-management, empowerment, self-efficacy, treatment satisfaction, and psychological well-being as well as fasting blood glucose values.

conclusionThis digital health tool has been previously implemented in several independent pilot studies. The findings from this multicenter randomized controlled trial can provide further evidence supporting the effectiveness of this tool in patients with T2DM and serve as a basis for its clinical integration.

trial registrationGerman Register for Clinical Studies-DRKS-ID: DRKS00024861.

Indexed as

Diabetes Mellitus, Type 2Mobile ApplicationsBlood GlucoseDigital HealthGermanyGlycated HemoglobinHumansHypoglycemic AgentsInsulinMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicSmartphoneTelemedicineBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinbasal insulindigital applicationinsulin titrationtype 2 diabetes

Identifiers

PMID36602040
PMCPMC11307223

What OpenQuestion holds

Textmetadata
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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 OpenQuestion graph.