Evidence map›Paper›PMID 38554220›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2024

Effectiveness of a Lifestyle Improvement Support App in Combination with a Wearable Device in Japanese People with Type 2 Diabetes Mellitus: STEP-DM Study.

Akiko Takahashi, Manabu Ishii, Yurika Kino, Kazuyo Sasaki, Takahiro Matsui, Kenji Arakawa, Makoto Kunisaki

Abstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

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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.

Akiko TakahashiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. takahashi.akiko@md.mt-pharma.co.jp.ORCID http://orcid.org/0009-0006-4275-4654
Manabu IshiiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID http://orcid.org/0009-0008-3406-2150
Yurika KinoPharma Business Strategy Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID http://orcid.org/0009-0007-5725-4940
Kazuyo SasakiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID http://orcid.org/0000-0001-5267-8284
Takahiro MatsuiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
Kenji ArakawaIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID http://orcid.org/0000-0001-9900-9491
Makoto KunisakiKunisaki Makoto Clinic, Fukuoka, Japan.ORCID http://orcid.org/0009-0005-8188-5895

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAlthough the use of application (app)s and wearable devices supporting diabetes treatment has spread rapidly in recent years, evidence of their impact, especially in combination of them, is limited. TOMOCO™ is a lifestyle improvement support app that features interactive virtual conversations according to the programmed algorithm guiding users toward their goals of lifestyle improvement. We hypothesized that TOMOCO™ in combination with Fitbit, which accurately tracks users' activity level, would encourage people with type 2 diabetes mellitus (T2DM) to change their lifestyles and improve their glycated hemoglobin (HbA1c) levels without changes in conventional therapy. Thus, we performed the present study to explore the effectiveness of this combination in Japanese participants with T2DM who had not achieved their glycemic targets.

methodsIn this single-arm exploratory study, participants with T2DM used the TOMOCO™ and Fitbit in addition to the conventional diet/exercise therapy and anti-diabetic drug for 12 weeks. They were provided with feedback/advice by health care providers based on the TOMOCO™ and Fitbit records. The primary endpoint was the change in HbA1c from baseline to the end of the observation period. Data were expressed as mean ± standard deviation.

resultsFifty-nine (96.7%) of the 61 participants (male, 42 [71.2%]; age, 60.1 ± 8.7 years; HbA1c level, 7.48 ± 0.37% at screening) completed the study. At the end of the observation period, the HbA1c was significantly reduced (- 0.41 ± 0.41%, p < 0.001). This trend was consistent across the preselected patient characteristics, including sex, age, and body mass index. However, it was more pronounced in the participants with earlier stages of behavioral changes defined by the transtheoretical model at baseline.

conclusionsThe unique features of TOMOCO™ in combination with Fitbit, together with conventional therapy, may promote a healthy lifestyle and thus contribute to improving HbA1c in people with T2DM. CLINICAL

trial registrationjRCT1070220007.

Indexed as

Behavioral changeSelf-managementSmartphone appType 2 diabetes mellitusWearable device

Identifiers

PMID38554220
PMCPMC11043275

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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.