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

PT Bio Farma

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Manual Records; Device: Medwell Preventive Care Application

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05657769

Medwell-01-2022

Details and patient eligibility

About

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

Full 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%.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Group I (Treatment)

Experimental group

Description:

Regular diabetes treatment with additional Medwell application and wearable device.

Treatment:

Device: Medwell Preventive Care Application

Group II (Control)

Active Comparator group

Description:

Regular diabetes treatment only with a diary card to record daily activities manually.

Treatment:

Device: Manual Records