UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056609 |
|---|---|
| Receipt number | R000064676 |
| Scientific Title | Evaluation of the Effectiveness of a Peer-Support Habit-Forming App Intervention on HbA1c Improvement in Patients with Type 2 diabetes mellitus |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2026/09/17 16:24:58 |
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Basic information
Public title
Evaluation of the Effect of a Peer-Support App on HbA1c Improvement in Patients with Type 2 diabetes mellitus
Acronym
Evaluation of the HbA1c Improvement Effect of a Peer-Support App
Scientific Title
Evaluation of the Effectiveness of a Peer-Support Habit-Forming App Intervention on HbA1c Improvement in Patients with Type 2 diabetes mellitus
Scientific Title:Acronym
Evaluation of the HbA1c Improvement Effect of a Peer-Support App
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effect of a peer-support habit-forming app on HbA1c levels in patients with Type 2 diabetes mellitus, whose baseline HbA1c levels range from 7.0% to 8.4%. Patients will be randomly assigned to either the app usage group or the non-usage group. The intervention will be conducted over a period of 24 weeks, in addition to standard medical care and guidance provided by physicians.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Between-group comparison of changes in HbA1c levels from baseline to week 24 of the treatment period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The app usage group will share blood glucose management reports in teams of five and conduct measurements of body weight, blood pressure, and blood tests at 12 and 24 weeks.
Interventions/Control_2
The non-usage group will work on achieving their goals individually without sharing results. Measurements of body weight, blood pressure, and blood tests will be conducted at 12 and 24 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Aged 18 to 74 years
2.Patients with type 2 diabetes mellitus, HbA1c between 7.0% and 8.4%
3.Possess a smartphone capable of installing and operating the app
Key exclusion criteria
1.Difficulty communicating in Japanese
2.Unable to walk independently
3.Previously used this app
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kyoichiro |
| Middle name | |
| Last name | Tsuchiya |
Organization
University of Yamanashi Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
409-3898
Address
1110 Shimokato, Chuo-shi, Yamanashi
TEL
055-273-3310
tsuchiyak@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Harai |
Organization
University of Yamanashi Hospital
Division name
Department of Diabetes and Endocrinology
Zip code
409-3898
Address
1110 Shimokato, Chuo-shi, Yamanashi
TEL
0552733310
Homepage URL
knozomi@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi Hospital
Institute
Department
Personal name
Funding Source
Organization
A10 Lab Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamanashi Prefectural Central Hospital
Enzan Citizen Hospital
Ichikawa Medical Clinic
Kitamura Clinic
Nakazato Medical Clinic
National Hospital Organization Kofu National Hospital
Fuefuki Central Hospital
Chuo Internal Medicine Clinic
Fujiyoshida Municipal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi
Address
University of Yamanashi
Tel
055-273-1111
rec-med@yamanashi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
None.
Publication of results
Unpublished
Result
URL related to results and publications
None.
Number of participants that the trial has enrolled
99
Results
At 6 months, 45 of 53 participants in the app group and 44 of 46 in the control group completed the assessment. In the overall analysis, the change in HbA1c from baseline to 6 months did not differ significantly between the groups.
Results date posted
| 2026 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 99 patients with type 2 diabetes, who were randomly assigned to the app group (n=53) and the control group (n=46). At baseline, the mean age was 53.4 years in the app group and 53.8 years in the control group, with males comprising 47.2% and 67.4%, respectively. The mean HbA1c was relatively well controlled at 7.58% in the app group and 7.44% in the control group, and the median diabetes duration was 130 months and 168 months, respectively. Participants were receiving treatment with antidiabetic medications, including insulin. The prevalence of microvascular complications in the app and control groups, respectively, was 26.4% and 32.6% for diabetic neuropathy, 22.6% and 34.8% for diabetic retinopathy, and 30.2% and 37.0% for diabetic nephropathy.
Participant flow
A total of 99 participants were enrolled and randomly assigned to the app group (n=53) or the control group (n=46), all of whom were included in the intention-to-treat (ITT) analysis. For the per-protocol set (PPS) analysis, 7 participants in the app group who never used the app were excluded, resulting in 46 participants in each group. During the study period, 8 participants (6 in the app group and 2 in the control group) withdrew due to personal reasons. Ultimately, 45 participants (84.9%) in the app group and 44 participants (95.7%) in the control group completed the 6-month assessment.
Adverse events
None.
Outcome measures
Primary Outcome:Change in HbA1c from baseline to 6 months.
Secondary Outcomes:Changes in body weight. Changes in systolic and diastolic blood pressure. Changes in lipid parameters, including LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), and triglycerides (TG). Changes in diabetes-related emotional distress measured by the Problem Areas in Diabetes (PAID). Changes in average daily step counts over the 3- to 6-month study period.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 31 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064676
