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

NCT05027334 | Completed

• 1 other identifier: UoM/R213
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, E health, glycaemic control, physical activity

Outcome Measures

Primary Outcomes (2)

• Glycaemic control

  The glycaemic control was measured through glycated haemoglobin (HbA1c)

  3 months

• Fasting blood glucose (FBG)

  FBG was measured on a daily basis and a reduction in FBG was sought.

  3 months

Secondary Outcomes (1)

• Weight

  3 months

Study Arms (1)

Interventional arm

EXPERIMENTAL

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

Other: DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes

Interventions

DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes OTHER

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.

Interventional arm

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Mauritius: lead

Study Sites (1)

University of Mauritius

Réduit, Moka District, 80837, Mauritius

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Abha Jodheea-Jutton

  University of Mauritius

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Single group assignment

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 30, 2021
• Study Start: July 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

MA (1)