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Self-Management of Type-2 Diabetes Using a Mobile Application

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Mauritius
Study Type
Interventional
Intervention
DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes
Sponsored by
University of Mauritius
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, E health, glycaemic control, physical activity

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with HbA1c 7-8% (stable T2DM) Patients with Impaired fasting glucose or impaired glucose tolerance Patients between 18 -74 years Both males and female patients Participants diagnosed with T2DM Participants able to provide consent Participants able to use the SMART phones

Exclusion Criteria:

  • Patients with HbA1c >9% (poorly controlled DM) Patients with type 1 diabetes mellitus Pregnant women Patients with gestational DM Patients unable to use smart devices Patients unable to provide consent People with other chronic diseases or health problems which can interfere with glycaemic control (e.g brittle asthma/COPD and using oral steroids)

Sites / Locations

  • University of Mauritius

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional arm

Arm Description

Participants will be asked to use a designed mobile app to monitor their blood sugar levels

Outcomes

Primary Outcome Measures

Glycaemic control
The glycaemic control was measured through glycated haemoglobin (HbA1c)
Fasting blood glucose (FBG)
FBG was measured on a daily basis and a reduction in FBG was sought.

Secondary Outcome Measures

Weight
a change in weight was measured through measurement of weight before and after the intervention

Full Information

First Posted
August 25, 2021
Last Updated
August 25, 2021
Sponsor
University of Mauritius
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1. Study Identification

Unique Protocol Identification Number
NCT05027334
Brief Title
Self-Management of Type-2 Diabetes Using a Mobile Application
Official Title
A Mobile System Framework to Support the Autonomous Self-management of Pre-diabetes and Type 2 Diabetes Mellitus Patients in Mauritius
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mauritius

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diabetes Mellitus (DM) is a global health emergency, since its prevalence has become alarming in many countries in the previous years. Because of the increasing healthcare requirement, it has also progressively become an economic burden for every country. From the International Diabetes Federation (IDF) Atlas (International Diabetes Federation, 2015), 415 million people worldwide were estimated to have DM in 2015 and this figure is expected to rise to 642 million in 2040. DM contributed to 5 million adult deaths globally in 2015. Mauritius has one of the highest DM prevalence in the world (24.3% prevalence for ages 20 - 79) for 2015 (International Diabetes Federation, 2015). 2,932 adult died due to Diabetes, and the average cost of DM related problems amount to 2 billion rupees per year. The Mauritius Non Communicable Diseases Survey (Ministry of Health and Quality of Life, 2015) reports an estimated 257,442 people between the ages of 25 and 74 with Diabetes in Mauritius. A high prevalence of pre-diabetes is also noted, which may subsequently result in diabetes and heart disease, if not appropriately managed. The DM epidemic has a significant impact locally and globally, calling for urgent remedial strategies to curb the spread. Studies have shown that patient's self-care including monitoring of blood glucose improve glycemic control (Allemann et al, 2009; Skeie et al, 2009; Istepanian et al, 2009). Patients are currently empowered through face to face counselling, websites, social media and other state of the art technologies. The use of smart phones for self-monitoring of blood glucose has shown to have substantial beneficial effects (Liang et al, 2011; Pal et al 2014). This project aims at using mobile technologies to instil behavioural changes in people living with DM and pre-diabetes in an attempt to alleviate the long term problems associated with DM. More precisely, it will constitute the development of an autonomous system for self-management of type 2 diabetes mellitus (T2DM) patients in Mauritius. The prototype will be tested for feasibility among patients with T2DM and pre-diabetes. It is expected that the proposed system will help to reduce the financial burden on the healthcare system in Mauritius through patient empowerment and improved self-care in the long run.
Detailed Description
he global burden of diabetes mellitus is an issue of increasing concern globally. The social and economic burden is soaring, pushing scientist to discover alternative options to reduce the burden. It is estimated that the burden is worse in countries with limited resources such as Mauritius. Mauritius has one of the highest DM prevalence in the world (24.3% prevalence for ages 20 - 79) for 2015 (International Diabetes Federation, 2015). 2,932 adult died due to diabetes, and the average cost of DM related problems amount to 2 billion rupees per year. The Mauritius Non Communicable Diseases Survey (Ministry of Health and Quality of Life, 2015) reports an estimated 257,442 people between the ages of 25 and 74 with Diabetes in Mauritius. A high prevalence of pre-diabetes is also noted, which may subsequently result in diabetes and heart disease, if not appropriately managed. The DM epidemic has a significant impact locally and globally, calling for urgent remedial strategies to curb the spread. Studies have shown that patient's self-care including monitoring of blood glucose improve glycemic control (Allemann et al, 2009; Skeie et al, 2009; Istepanian et al, 2009). Patients are currently empowered through face to face counselling, websites, social media and other state of the art technologies. The use of smart phones for self-monitoring of blood glucose has shown to have substantial beneficial effects (Liang et al, 2011; Pal et al 2014). Aims and objectives: The aim of the study is to evaluate the effect on glycaemic levels among patients living with type 2 diabetes who are using a newly designed mobile application. The objectives are to: Measure the change in HbA1c after 3 months of using the application Compare secondary outcomes such as weight and BMI following the use of the application Assess the perception of patients using the digital tool and relate behavioural changes with the use of the application Methodology: A single arm prospective non randomised study is proposed. Participants will be recruited using adverts in the local newspapers and social media. Interested participants will be screened for eligibility and given the mobile application to use. They will be advised to record their daily fasting and post-prandial blood glucose as well as their levels of physical activity. The following clinical and biomarkers will be checked before and after the use of the intervention: HbA1c, FBS, weight, BMI and blood pressure. The duration of follow up will be 3-6 months. An investigator designed questionnaire will be used to evaluate the use of the mobile app.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, E health, glycaemic control, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Participants will be asked to use a designed mobile app to monitor their blood sugar levels
Intervention Type
Other
Intervention Name(s)
DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes
Intervention Description
Each participant will be provided with a mobile application aimed at monitoring their clinical markers such as FBG and HbA1c. The mobile application consists of medical details and demographics as well as a section dedicated to daily glucose levels and record of physical activity.
Primary Outcome Measure Information:
Title
Glycaemic control
Description
The glycaemic control was measured through glycated haemoglobin (HbA1c)
Time Frame
3 months
Title
Fasting blood glucose (FBG)
Description
FBG was measured on a daily basis and a reduction in FBG was sought.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight
Description
a change in weight was measured through measurement of weight before and after the intervention
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with HbA1c 7-8% (stable T2DM) Patients with Impaired fasting glucose or impaired glucose tolerance Patients between 18 -74 years Both males and female patients Participants diagnosed with T2DM Participants able to provide consent Participants able to use the SMART phones Exclusion Criteria: Patients with HbA1c >9% (poorly controlled DM) Patients with type 1 diabetes mellitus Pregnant women Patients with gestational DM Patients unable to use smart devices Patients unable to provide consent People with other chronic diseases or health problems which can interfere with glycaemic control (e.g brittle asthma/COPD and using oral steroids)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abha Jodheea-Jutton
Organizational Affiliation
University of Mauritius
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mauritius
City
Le Réduit
State/Province
Moka
ZIP/Postal Code
80837
Country
Mauritius

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The individual participant Data has been recorded in an anonymous format digitally and is available upon request.

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Self-Management of Type-2 Diabetes Using a Mobile Application

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