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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Recruiting

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Medwell Preventive Care Application

Manual Records

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Immanuel HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (Treatment)

Group II (Control)

Arm Description

Regular diabetes treatment with additional Medwell application and wearable device.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the exercise

Mean weekly frequency of exercise

Evaluate the exercise

Proportion of exercise prescribed by physicians timely performed by subjects

Evaluate the exercise

Mean duration of each exercise

Drug Adherence

Proportion of administered drugs timely consumed by subjects

Anthropometry I (BMI)

Change in the BMI after 3 months

Anthropometry II (Body Fat)

Change in the Body Fat after 3 months

Anthropometry III (Muscle Mass)

Change in the Muscle Mass after 3 months

Lab outcome I (Fasting glucose)

Change in the lab measurement from baseline to month 3 for fasting glucose

Lab outcome II (2 hours post prandial glucose)

Change in the lab measurement from baseline to month 3 for 2 hours postprandial glucose

Lab outcome III (total cholesterol)

Change in the lab measurement from baseline to month 3 for total cholesterol

Lab outcome IV (low density lipoprotein)

Change in the lab measurement from baseline to month 3 for low density lipoprotein

Lab outcome V (high density lipoprotein)

Change in the lab measurement from baseline to month 3 for high density lipoprotein

Lab outcome VI (triglyceride)

Change in the lab measurement from baseline to month 3 for triglyceride

Full Information

NCT ID

NCT05657769

First Posted

December 12, 2022

Last Updated

April 17, 2023

Sponsor

PT Bio Farma

Collaborators

Immanuel Hospital, Prodia the CRO

1. Study Identification

Unique Protocol Identification Number

NCT05657769

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 12, 2022 (Actual)

Primary Completion Date

May 30, 2023 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT Bio Farma

Collaborators

Immanuel Hospital, Prodia the CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I (Treatment)

Arm Type

Experimental

Arm Description

Regular diabetes treatment with additional Medwell application and wearable device.

Arm Title

Group II (Control)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Medwell Preventive Care Application

Intervention Description

Regular diabetes treatment with additional Medwell application and wearable device.

Intervention Type

Device

Intervention Name(s)

Manual Records

Intervention Description

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

Primary Outcome Measure Information:

Title

HbA1C Changes

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Evaluate the exercise

Description

Mean weekly frequency of exercise

Time Frame

3 months

Title

Evaluate the exercise

Description

Proportion of exercise prescribed by physicians timely performed by subjects

Time Frame

3 months

Title

Evaluate the exercise

Description

Mean duration of each exercise

Time Frame

3 months

Title

Drug Adherence

Description

Proportion of administered drugs timely consumed by subjects

Time Frame

3 months

Title

Anthropometry I (BMI)

Description

Change in the BMI after 3 months

Time Frame

3 months

Title

Anthropometry II (Body Fat)

Description

Change in the Body Fat after 3 months

Time Frame

3 months

Title

Anthropometry III (Muscle Mass)

Description

Change in the Muscle Mass after 3 months

Time Frame

3 months

Title

Lab outcome I (Fasting glucose)

Description

Change in the lab measurement from baseline to month 3 for fasting glucose

Time Frame

3 months

Title

Lab outcome II (2 hours post prandial glucose)

Description

Change in the lab measurement from baseline to month 3 for 2 hours postprandial glucose

Time Frame

3 months

Title

Lab outcome III (total cholesterol)

Description

Change in the lab measurement from baseline to month 3 for total cholesterol

Time Frame

3 months

Title

Lab outcome IV (low density lipoprotein)

Description

Change in the lab measurement from baseline to month 3 for low density lipoprotein

Time Frame

3 months

Title

Lab outcome V (high density lipoprotein)

Description

Change in the lab measurement from baseline to month 3 for high density lipoprotein

Time Frame

3 months

Title

Lab outcome VI (triglyceride)

Description

Change in the lab measurement from baseline to month 3 for triglyceride

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Asep Irham, MD

Phone

+62222033755

asep.irham@biofarma.co.id

First Name & Middle Initial & Last Name or Official Title & Degree

Salwa Halimatussadiy

Phone

+62222033755

salwa.halimatussadiy@biofarma.co.id

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ratih Nursiana

Organizational Affiliation

RS Immanuel

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Indahwaty Indahwaty

Organizational Affiliation

RS Immanuel

Official's Role

Study Director

Facility Information:

Facility Name

Immanuel Hospital

City

Bandung

State/Province

West Java

ZIP/Postal Code

40234

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Indahwaty Indahwaty

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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