Preventive Care System Application Effectiveness Study on the Treatment of Diabetic Patients in Bandung
NCT ID: NCT05657769
Last Updated: 2023-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2022-11-12
2023-05-30
Brief Summary
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Detailed Description
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The primary endpoint will be measured as the difference between 3 months HbA1c relative to baseline in eligible subjects. Normally, HbA1c in each subject is expected to either stable or slightly increase overtime. In this study we are interested in measuring the difference in HbA1c 3 months post randomization. It is expected that in the experimental arm, HbA1c will slightly decrease, while in the standard arm, HbA1c will either remain the same or will slightly increase after 3 months in the study. Previous study shows that the standard deviation of the difference in HbA1c within 1 year is 0.97%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (Treatment)
Regular diabetes treatment with additional Medwell application and wearable device.
Medwell Preventive Care Application
Regular diabetes treatment with additional Medwell application and wearable device.
Group II (Control)
Regular diabetes treatment only with a diary card to record daily activities manually.
Manual Records
Regular diabetes treatment only with a diary card to record daily activities manually.
Interventions
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Medwell Preventive Care Application
Regular diabetes treatment with additional Medwell application and wearable device.
Manual Records
Regular diabetes treatment only with a diary card to record daily activities manually.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 - 60 years old
* Have compatible smartphone (minimum android 8 or iOS 13) and internet connection
* Receiving regular diabetes treatment
* Giving consent and commitment to participate in the study until finish
* Located in Bandung Area within the treatment period (up to 3 month after receiving the treatment)
* Subject is determined to be able to complete daily physical activities.
Exclusion Criteria
* Participation in other weight loss program
* Use of other tracking application
* Having any abnormalities that affecting blood erythrocyte age defined by laboratory examination
* Have other severe diabetic complications that prevent subjects from participating in the prescribed program (Such as stroke, cardiac diseases (CHF stage III-IV), COPD or asthma with acute exacerbation and other respiratory diseases, peripheral artery disease, CKD stage 3-5) and other severe diseases that by the investigator's judgment, could not participate in this study
18 Years
60 Years
ALL
No
Sponsors
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Immanuel Hospital
UNKNOWN
Prodia the CRO
UNKNOWN
PT Bio Farma
INDUSTRY
Responsible Party
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Principal Investigators
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Ratih Nursiana
Role: PRINCIPAL_INVESTIGATOR
RS Immanuel
Indahwaty Indahwaty
Role: STUDY_DIRECTOR
RS Immanuel
Locations
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Immanuel Hospital
Bandung, West Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Indahwaty Indahwaty
Role: primary
Other Identifiers
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Medwell-01-2022
Identifier Type: -
Identifier Source: org_study_id
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