NCT05657769

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

A Randomized Trial of Preventive Care System Application Effectiveness on the Treatment of Diabetic Patients in Bandung

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Medwell Preventive Care Application	Regular diabetes treatment with additional Medwell application and wearable device.
DEVICE	Manual Records	Regular diabetes treatment only with a diary card to record daily activities manually.

Timeline

• Start date: 2022-11-12
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2022-12-20
• Last updated: 2023-04-19

Locations

1 site across 1 country: Indonesia