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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657769
• Other study ID #: Medwell-01-2022
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: April 2023
• Source: PT Bio Farma
• Contact: Asep Irham, MD
• Phone: +62222033755
• Email: asep.irham[@]biofarma.co.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, unblinded, controlled, two arms parallel group, prospective intervention 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Indonesia	Immanuel Hospital	Bandung	West Java

Sponsors (3)

Lead Sponsor	Collaborator
PT Bio Farma	Immanuel Hospital, Prodia the CRO

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C Changes	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	3 months
Secondary	Evaluate the exercise	Mean weekly frequency of exercise	3 months
Secondary	Evaluate the exercise	Proportion of exercise prescribed by physicians timely performed by subjects	3 months
Secondary	Evaluate the exercise	Mean duration of each exercise	3 months
Secondary	Drug Adherence	Proportion of administered drugs timely consumed by subjects	3 months
Secondary	Anthropometry I (BMI)	Change in the BMI after 3 months	3 months
Secondary	Anthropometry II (Body Fat)	Change in the Body Fat after 3 months	3 months
Secondary	Anthropometry III (Muscle Mass)	Change in the Muscle Mass after 3 months	3 months
Secondary	Lab outcome I (Fasting glucose)	Change in the lab measurement from baseline to month 3 for fasting glucose	3 months
Secondary	Lab outcome II (2 hours post prandial glucose)	Change in the lab measurement from baseline to month 3 for 2 hours postprandial glucose	3 months
Secondary	Lab outcome III (total cholesterol)	Change in the lab measurement from baseline to month 3 for total cholesterol	3 months
Secondary	Lab outcome IV (low density lipoprotein)	Change in the lab measurement from baseline to month 3 for low density lipoprotein	3 months
Secondary	Lab outcome V (high density lipoprotein)	Change in the lab measurement from baseline to month 3 for high density lipoprotein	3 months
Secondary	Lab outcome VI (triglyceride)	Change in the lab measurement from baseline to month 3 for triglyceride	3 months