Diabetes MellitusNCT05027334
Self-Management of Type-2 Diabetes Using a Mobile Application
A study testing DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes in people with Diabetes Mellitus, run by University of Mauritius at 1 site in Mauritius.
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteMauritius
- Study dates
- 1 Jul 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mobile System Framework to Support the Autonomous Self-management of Pre-diabetes and Type 2 Diabetes Mellitus Patients in Mauritius
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes
- Keywords
- Type 2 Diabetes Mellitus, E health, glycaemic control, physical activity
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Participants will be asked to use a designed mobile app to monitor their blood sugar levels Receives: Other: DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic control
The glycaemic control was measured through glycated haemoglobin (HbA1c)
Measured: 3 months
Fasting blood glucose (FBG)
FBG was measured on a daily basis and a reduction in FBG was sought.
Measured: 3 months
Secondary outcomes (1)
Weight
a change in weight was measured through measurement of weight before and after the intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Jul 2017
- Primary completion31 Mar 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mauritius
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abha Jodheea-Jutton, University of Mauritius
- Investigators
- Abha Jodheea-Jutton, Principal investigator, University of Mauritius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027334
- Sponsor's protocol ID
- UoM/R213
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant Data has been recorded in an anonymous format digitally and is available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile System Framework to Support the Autonomous Self-management of Pre-diabetes and Type 2 Diabetes Mellitus Patients in Mauritius
- ClinicalTrials.gov ID
- NCT05027334
- Acronym / sponsor ID
- UoM/R213
- Conditions
- Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, E health, glycaemic control, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MauritiusUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Other: DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetesParticipants will be asked to use a designed mobile app to monitor their blood sugar levels |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetesEach 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. | Other | Interventional arm |
Primary outcome
Glycaemic control
Time frame: 3 months
The glycaemic control was measured through glycated haemoglobin (HbA1c)
Fasting blood glucose (FBG)
Time frame: 3 months
FBG was measured on a daily basis and a reduction in FBG was sought.
1 secondary outcome
Weight
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: Undecided. The individual participant Data has been recorded in an anonymous format digitally and is available upon request.
Related trials for Diabetes Mellitus
RecruitingObservational study
Diabetes and Heart Disease Risk in Blacks
Cardiovascular Diseases, Diabetes
RecruitingObservational study
Genetic Studies of Insulin and Diabetes
Diabetes Mellitus, Severe Insulin Resistance
RecruitingObservational study
Urinary Vitamin C Loss in Diabetic Subjects
Diabetes
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Active, not recruiting
Dietary Behavior Intervention in African Americans at Risk for Cardiovascular Disease
Diet, Cooking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abha Jodheea-Jutton principal investigator
University of Mauritius
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes in people with Diabetes Mellitus, run by University of Mauritius at 1 site in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic control (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.