Diabete MellitusNCT07774078
Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Diabetes Mellitus Tunisian Patients
A study testing Telemonitoring group in people with Diabete Mellitus and Telemonitoring, run by University of Monastir at 1 site in Tunisia.
Trial summary
The study aims to evaluate the impact of a telemonitoring system on glycemic control in patients with diabetes in Tunisia. Participants in the intervention group will receive remote diabetes management through a dedicated mobile application and web platform, while the control group will receive standard diabetes care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus, Telemonitoring
- What is being tested?
- Telemonitoring group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus with HbA1c between 7% and 10%.
- Stable antidiabetic treatment for at least 4 weeks prior to enrollment.
Who cannot join
- Serum creatinine >200 µmol/L.
- Acute coronary syndrome or stroke.
- Dementia.
- Pregnancy.
- Inability to participate in or comply with the telemonitoring intervention.
- Severe diabetic retinopathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
University Hospital Fattouma Bourguiba Monastir
Monastir
Nouira Semir, Professor, 0021673106046, semir.nouira@rns.tn
About this study
Official title: Evaluation of the Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Tunisian Patients With Diabetes Mellitus: a Study Protocol
The study aims to evaluate the impact of a telemonitoring system on glycemic control in patients with diabetes in Tunisia. Participants in the intervention group will receive remote diabetes management through a dedicated mobile application and web platform, while the control group will receive standard diabetes care. The primary objective is to determine the effectiveness of telemonitoring in improving glycemic control, as assessed by changes in glycated hemoglobin (HbA1c) and blood glucose levels.
- Conditions
- Diabete Mellitus, Telemonitoring
- Being tested
- Telemonitoring group, Usual Care Group
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring groupDevice
Participants in the telemonitoring group receive a connected blood glucose meter, which automatically transmits all blood glucose readings to a dedicated online telemonitoring platform.
Usual Care GroupOther
Standard follow-up will including at least three scheduled study visits at Day 15, Month 3, and Month 6.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring Group | Experimental | Participants in the telemonitoring group receive a connected blood glucose meter, which automatically transmits all blood glucose readings to a dedicated online telemonitoring platform. Receives: Device: Telemonitoring group |
| Standard Care Group | Active comparator | Participants in the usual care group will receive standard diabetes management according to routine clinical practice, at the discretion of their treating physicians. The standard follow-up will include at least three scheduled study visits at Day 15, Month 3, and Month 6. The same clinical and study data will be collected at each visit as in the telemonitoring group. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Glucose Level (mmol/L)
Change in blood glucose level, measured in mmol/L, from baseline to 6 months, comparing the telemonitoring group with the standard diabetes care group.
Measured: Baseline to 6 months
Change in Glycated Hemoglobin (HbA1c) (%)
Change in glycated hemoglobin (HbA1c), measured as a percentage (%), from baseline to 6 months, comparing the telemonitoring group with the standard diabetes care group.
Measured: Baseline to 6 months
Secondary outcomes (9)
Change in body weight
Measured: Baseline to 6 months
Change in body mass index (BMI)
Measured: Baseline to 6 months
Change in urinary albumin concentration measured in mg/L.
Measured: Baseline to 6 months
Medication adherence assessed by MARS-5
Measured: Baseline to 6 months
Medication adherence assessed by Medication Possession Ratio (MPR)
Measured: Baseline to 6 months
Change in Skin Autofluorescence (AGEs) Measured by AGE Reader
Skin autofluorescence, reflecting tissue accumulation of advanced glycation end-products (AGEs), will be measured using the AGE Reader. The change in skin autofluorescence from baseline to 6 months will be reported.
Measured: Baseline to 6 months
Change in reactive hyperemia index (RHI)
Measured: Baseline to 6 months
Number of Participants with Hospitalizations
Measured: Baseline to 6 months
Number of Participants with Emergency Department Visits
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774078
- Sponsor's protocol ID
- e-DIABISCOPE
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Tunisian Patients With Diabetes Mellitus: a Study Protocol
- ClinicalTrials.gov ID
- NCT07774078
- Acronym / sponsor ID
- e-DIABISCOPE
- Conditions
- Diabete Mellitus, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 2026 (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.
The study aims to evaluate the impact of a telemonitoring system on glycemic control in patients with diabetes in Tunisia. Participants in the intervention group will receive remote diabetes management through a dedicated mobile application and web platform, while the control group will receive standard diabetes care. The primary objective is to determine the effectiveness of telemonitoring in improving glycemic control, as assessed by changes in glycated hemoglobin (HbA1c) and blood glucose levels.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring Group | Experimental | Device: Telemonitoring groupParticipants in the telemonitoring group receive a connected blood glucose meter, which automatically transmits all blood glucose readings to a dedicated online telemonitoring platform. |
| Standard Care Group | Active comparator | Other: Usual Care GroupParticipants in the usual care group will receive standard diabetes management according to routine clinical practice, at the discretion of their treating physicians. The standard follow-up will include at least three scheduled study visits at Day 15, Month 3, and Month 6. The same clinical and study data will be collected at each visit as in the telemonitoring group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of diabetes mellitus with HbA1c between 7% and 10%.
- Stable antidiabetic treatment for at least 4 weeks prior to enrollment.
Key exclusion criteria (6 listed)
- Serum creatinine >200 µmol/L.
- Acute coronary syndrome or stroke.
- Dementia.
- Pregnancy.
- Inability to participate in or comply with the telemonitoring intervention.
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 |
|---|---|---|
| Telemonitoring groupParticipants in the telemonitoring group receive a connected blood glucose meter, which automatically transmits all blood glucose readings to a dedicated online telemonitoring platform. | Device | Telemonitoring Group |
| Usual Care GroupStandard follow-up will including at least three scheduled study visits at Day 15, Month 3, and Month 6. | Other | Standard Care Group |
Primary outcome
Change in Blood Glucose Level (mmol/L)
Time frame: Baseline to 6 months
Change in blood glucose level, measured in mmol/L, from baseline to 6 months, comparing the telemonitoring group with the standard diabetes care group.
Change in Glycated Hemoglobin (HbA1c) (%)
Time frame: Baseline to 6 months
Change in glycated hemoglobin (HbA1c), measured as a percentage (%), from baseline to 6 months, comparing the telemonitoring group with the standard diabetes care group.
9 secondary outcomes
Change in body weight
Time frame: Baseline to 6 months
Change in body mass index (BMI)
Time frame: Baseline to 6 months
Change in urinary albumin concentration measured in mg/L.
Time frame: Baseline to 6 months
Medication adherence assessed by MARS-5
Time frame: Baseline to 6 months
Medication adherence assessed by Medication Possession Ratio (MPR)
Time frame: Baseline to 6 months
Change in Skin Autofluorescence (AGEs) Measured by AGE Reader
Time frame: Baseline to 6 months
Change in reactive hyperemia index (RHI)
Time frame: Baseline to 6 months
Number of Participants with Hospitalizations
Time frame: Baseline to 6 months
Number of Participants with Emergency Department Visits
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring group in people with Diabete Mellitus and Telemonitoring, run by University of Monastir at 1 site in Tunisia.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. 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 Tunisia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nouira Semir (0021673106046, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Glucose Level (mmol/L) (time frame: Baseline to 6 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 20 Aug 2026.