Preventive Care System Application Effectiveness Study on the Treatment of Diabetic Patients in Bandung

Last updated: April 17, 2023
Sponsor: PT Bio Farma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT05657769
Medwell-01-2022
  • Ages 18-60
  • All Genders

Study Summary

Randomized, unblinded, controlled, two arms parallel group, prospective intervention study

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects are in the diabetes type 2 status (based on Perkeni standard) HbA1c is ≥6.5%
  • 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 thetreatment)
  • Subject is determined to be able to complete daily physical activities.

Exclusion

Exclusion Criteria:

  • Pregnant (based on test pack)
  • Participation in other weight loss program
  • Use of other tracking application
  • Having any abnormalities that affecting blood erythrocyte age defined by laboratoryexamination
  • Have other severe diabetic complications that prevent subjects from participating inthe prescribed program (Such as stroke, cardiac diseases (CHF stage III-IV), COPD orasthma with acute exacerbation and other respiratory diseases, peripheral arterydisease, CKD stage 3-5) and other severe diseases that by the investigator's judgment,could not participate in this study

Study Design

Total Participants: 160
Study Start date:
November 12, 2022
Estimated Completion Date:
May 30, 2023

Study Description

The objective of the study is to compare the progression of HbA1c in diabetic patients after applying a Medwell digital application in addition to regular diabetes treatment (treatment arm) with regular diabetes treatment of diabetic subjects alone (control arm).

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%.

Connect with a study center

  • Immanuel Hospital

    Bandung, West Java 40234
    Indonesia

    Active - Recruiting

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