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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Manual Records; Device: Medwell Preventive Care Application

• Registration Number: NCT05657769
• Lead Sponsor: PT Bio Farma

Brief Summary

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

Detailed 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%.

Study Timeline

• Study Start: 2022-11-12
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 the treatment)
• Subject is determined to be able to complete daily physical activities.

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (Control)	Manual Records	Regular diabetes treatment only with a diary card to record daily activities manually.
Group I (Treatment)	Medwell Preventive Care Application	Regular diabetes treatment with additional Medwell application and wearable device.

Primary Outcome Measures

Name	Time	Method
HbA1C Changes	3 months	Change in HbA1c from baseline to month 3 for all groups.; Change in HbA1c from baseline to month 3 for all groups.; Change in HbA1C from baseline to moth 3 of all group

Secondary Outcome Measures

Name	Time	Method
Evaluate the exercise	3 months	Mean duration of each exercise
Drug Adherence	3 months	Proportion of administered drugs timely consumed by subjects
Anthropometry II (Body Fat)	3 months	Change in the Body Fat after 3 months
Lab outcome II (2 hours post prandial glucose)	3 months	Change in the lab measurement from baseline to month 3 for 2 hours postprandial glucose
Lab outcome V (high density lipoprotein)	3 months	Change in the lab measurement from baseline to month 3 for high density lipoprotein
Lab outcome VI (triglyceride)	3 months	Change in the lab measurement from baseline to month 3 for triglyceride
Lab outcome I (Fasting glucose)	3 months	Change in the lab measurement from baseline to month 3 for fasting glucose
Anthropometry III (Muscle Mass)	3 months	Change in the Muscle Mass after 3 months
Lab outcome III (total cholesterol)	3 months	Change in the lab measurement from baseline to month 3 for total cholesterol
Lab outcome IV (low density lipoprotein)	3 months	Change in the lab measurement from baseline to month 3 for low density lipoprotein
Anthropometry I (BMI)	3 months	Change in the BMI after 3 months

Trial Locations

Locations (1)

Immanuel Hospital; 🇮🇩 Bandung, West Java, Indonesia