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

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Medwell Preventive Care Application; Device: Manual Records

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asep Irham, MD; Phone Number: +62222033755; Email: asep.irham@biofarma.co.id
• Study Contact Backup: Name: Salwa Halimatussadiy; Phone Number: +62222033755; Email: salwa.halimatussadiy@biofarma.co.id

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia, 40234
      • Recruiting
      • Immanuel Hospital
      • Contact: Indahwaty Indahwaty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (Treatment); Regular diabetes treatment with additional Medwell application and wearable device.	Device: Medwell Preventive Care Application; Regular diabetes treatment with additional Medwell application and wearable device.
Active Comparator: Group II (Control); Regular diabetes treatment only with a diary card to record daily activities manually.	Device: Manual Records; Regular diabetes treatment only with a diary card to record daily activities manually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: Immanuel Hospital; Prodia the CRO
• Investigators: Principal Investigator: Ratih Nursiana, RS Immanuel; Study Director: Indahwaty Indahwaty, RS Immanuel

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Medwell-01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No