NCT04271631

Brief Summary

Diabetes mellitus is increasing in incidence worldwide. The goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. Self-management becomes important in the management of diabetes mellitus. The use of mobile phone applications provides opportunities for the management of diabetics. In addition, health coaching is one of method used for empowering patients with chronic diseases, such as diabetes. This study aims to evaluate the impact of Mobile Application-Based Diabetes Education and health coaching in management of type 2 diabetes mellitus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

February 7, 2020

Last Update Submit

February 12, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitusMobile Application-Based Diabetes EducationHealth Coaching

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Hb1A1c at 3 months

    Glycemic control

    3 months

Secondary Outcomes (9)

  • Change from Baseline Fasting plasma glucose at 3 months

    3 months after intervention

  • Change from Baseline 2 hours-post prandial plasma glucose at 3 months

    3 months after intervention

  • Change from Baseline Total cholesterol at 3 months

    3 months after intervention

  • Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months

    3 months after intervention

  • Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months

    3 months after intervention

  • +4 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

Received conventional education group

Intervention 1

EXPERIMENTAL

Received conventional education group and Mobile Application-Based Diabetes Education

Other: Mobile Application-Based Diabetes Education

Intervention 2

EXPERIMENTAL

Received Mobile Application-Based Diabetes Education and Health Coaching

Other: Mobile Application-Based Diabetes EducationOther: Health Coaching

Interventions

Mobile Application-Based Diabetes EducationOTHER

Additional education was given using application, subjects were asked to open the application at least once a day

Also known as: DM EduCorner Application
Intervention 1Intervention 2
Health CoachingOTHER

Health coaching was given as face to face with a coach

Intervention 2

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes Mellitus
  • multiple daily insulin injection (basal and rapid, or mixed)
  • years old
  • HbA1c \> 8%
  • Using smartphone in daily lives.
  • Willing to follow the research by signing an informed consent

You may not qualify if:

  • Patients with cognitive disease (such as dementia)
  • Patients with hearing or sight problem
  • Unable to live independently on daily basis
  • Patients who have disease that may affect Hba1c such as hemolytic anemia, thalassemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pradana Soewondo, Prof

    Fakultas Kedokteran Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open label
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Endocrinologist

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 17, 2020

Study Start

June 12, 2019

Primary Completion

January 31, 2020

Study Completion

May 31, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

ID(1)