Evidence mapPaperPMID 39255478Full record

Trial reportJournal of medical Internet research2024

Efficacy of Save Medical Corporation (SMC)-01, a Smartphone App Designed to Support Type 2 Diabetes Self-Management Based on Established Guidelines: Randomized Controlled Trial.

Nicholas Leung, Kayo Waki, Satoshi Nozoe, Shunpei Enomoto, Ryo Saito, Sakurako Hamagami, Toshimasa Yamauchi, Masaomi Nangaku, Kazuhiko Ohe, Yukiko Onishi

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of medical Internet research, 2024. 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. Article
  2. Article
  3. Review
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

10 authors.

Nicholas LeungDonald and Barbara Zucker School of Medicine, Hempstead, NY, United States.ORCID 0009-0009-1631-5094
Kayo WakiDepartment of Planning, Information and Management, University of Tokyo Hospital, Tokyo, Japan.ORCID 0000-0003-0046-2523
Satoshi NozoeSave Medical Corporation, Tokyo, Japan.ORCID 0009-0003-7989-0391
Shunpei EnomotoDepartment of Planning, Information and Management, University of Tokyo Hospital, Tokyo, Japan.ORCID 0000-0002-8770-9068
Ryo SaitoDepartment of Planning, Information and Management, University of Tokyo Hospital, Tokyo, Japan.ORCID 0000-0002-0529-2175
Sakurako HamagamiFaculty of Biology, University of Cambridge, Cambridge, United Kingdom.ORCID 0009-0008-3360-3015
Toshimasa YamauchiDepartment of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.ORCID 0000-0003-4827-6404
Masaomi NangakuDivision of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.ORCID 0000-0001-7401-2934
Kazuhiko OheDepartment of Planning, Information and Management, University of Tokyo Hospital, Tokyo, Japan.ORCID 0000-0002-4296-9536
Yukiko OnishiThe Institute of Medical Science, Asahi Life Foundation, Tokyo, Japan.ORCID 0000-0003-1180-5982

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLifestyle modifications are a key part of type 2 diabetes mellitus treatment. Many patients find long-term self-management difficult, and mobile apps could be a solution. In 2010, in the United States, a mobile app was approved as an official medical device. Similar apps have entered the Japanese market but are yet to be classified as medical devices.

objectiveThe objective of this study was to determine the efficacy of Save Medical Corporation (SMC)-01, a mobile app for the support of lifestyle modifications among Japanese patients with type 2 diabetes mellitus.

methodsThis was a 24-week multi-institutional, prospective randomized controlled trial. The intervention group received SMC-01, an app with functions allowing patients to record data and receive personalized feedback to encourage a healthier lifestyle. The control group used paper journals for diabetes self-management. The primary outcome was the between-group difference in change in hemoglobin A

resultsThe change in hemoglobin A

conclusionsThere was no statistically significant change in glycemic control. The lack of change could be due to SMC-01 insufficiently inducing behavior change, absence of screening for patients who have high intention to change their lifestyle, low effective usage of SMC-01 due to design issues, or problems with the SMC-01 intervention. Future efforts should focus on these issues in the early phase of developing interventions.

trial registrationJapan Registry of Clinical Trials jRCT2032200033; https://jrct.niph.go.jp/latest-detail/jRCT2032200033.

Indexed as

Diabetes Mellitus, Type 2Mobile ApplicationsPractice Guidelines as TopicSelf-ManagementSmartphoneAgedFemaleGlycated HemoglobinHumansJapanMaleMiddle AgedProspective StudiesGlycated Hemoglobinapp developmentbehavioral changediabetesdiabetes mellitusefficacyHbA1chemoglobin A1cJapanmHealthmobile appmobile appsmobile phonemulti-institutionalrandomized controlled trialRCTRCTssafetyself-managementsmartphone applicationT2DMtype 2 diabetes

Identifiers

PMID39255478
PMCPMC11429663

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.