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

NCT05657769 | Unknown

• 1 other identifier: Medwell-01-2022
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Evaluate the exercise

  3 months

• Evaluate the exercise

  3 months

• Evaluate the exercise

  3 months

• Drug Adherence

  3 months

• Anthropometry I (BMI)

  3 months

Study Arms (2)

Group I (Treatment)

EXPERIMENTAL

Regular diabetes treatment with additional Medwell application and wearable device.

Device: Medwell Preventive Care Application

Group II (Control)

ACTIVE COMPARATOR

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

Device: Manual Records

Interventions

Medwell Preventive Care Application DEVICE

Regular diabetes treatment with additional Medwell application and wearable device.

Group I (Treatment)

Manual Records DEVICE

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

Group II (Control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PT Bio Farma: lead
• Immanuel Hospital: collaborator
• Prodia the CRO: collaborator

Study Sites (1)

Immanuel Hospital

Bandung, West Java, 40234, Indonesia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ratih Nursiana

  RS Immanuel

  PRINCIPAL INVESTIGATOR

• Indahwaty Indahwaty

  RS Immanuel

  STUDY DIRECTOR

Central Study Contacts

Asep Irham, MD

CONTACT

+62222033755; asep.irham@biofarma.co.id

Salwa Halimatussadiy

CONTACT

+62222033755; salwa.halimatussadiy@biofarma.co.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is conducted with the primary hypothesis that the diabetes treatment with Medwell intervention can significantly reduce the HbA1c level better than without Medwell intervention.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: November 12, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)