Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05027334 |
| Other study ID # |
UoM/R213 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2017 |
| Est. completion date |
July 31, 2019 |
Study information
| Verified date |
August 2021 |
| Source |
University of Mauritius |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
