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RecruitingNCT07774078Updated Aug 20, 2026

Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Diabetes Mellitus Tunisian Patients

An interventional study of Telemonitoring group and Usual Care Group in Diabete Mellitus and Telemonitoring, sponsored by University of Monastir. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by University of Monastir · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Aug 2024, registered Jul 2026).
  • Started Aug 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Diabetes Mellitus with a site in Tunisia — 3 open to participants now, 4 under way, 1 of them phase 3. Diabetes Mellitus · Tunisia.

Started
2024
with 1 other
No phase
3 of 20
1 open now
Registered
20th of 20
by date
Lead sponsor
6 of 20
University of Monastir

Among the 20 studies in Diabetes Mellitus with a site in Tunisia, this one is one of 2 that started in 2024, is one of 3 with no phase, and was the 20th registered.

By phase

20 studies; the count open now beside each. This study's row is marked.

Observational11 · 0 open
No phasethis study3 · 1 open
Phase 43 · 1 open
Phase 2/32 · 1 open
Phase 11 · 0 open

By the year they started

First in 2008; this study’s year is marked. 2 started in 2024.

Size and results

Median enrollment 155 across the 9 interventional studies, 866 across the 11 observational. Of the 14 that completed or were terminated, 2 (14%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 20 studies in Diabetes Mellitus with a site in Tunisia, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Diabete Mellitus
  • Telemonitoring

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of diabetes mellitus with between 7% and 10%.
  • Stable antidiabetic treatment for at least 4 weeks prior to enrollment.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    Telemonitoring Group

    Participants 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

  • Active comparator
    Standard Care Group

    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.

    Other: Usual Care Group

Interventions

  • DeviceTelemonitoring group

    Participants in the telemonitoring group receive a connected blood glucose meter, which automatically transmits all blood glucose readings to a dedicated online telemonitoring platform.

  • OtherUsual Care Group

    Standard follow-up will including at least three scheduled study visits at Day 15, Month 3, and Month 6.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 6 months

  2. 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.

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Change in body weight

    Time frame: Baseline to 6 months

  2. Change in body mass index (BMI)

    Time frame: Baseline to 6 months

  3. Change in urinary albumin concentration measured in mg/L.

    Time frame: Baseline to 6 months

  4. Medication adherence assessed by MARS-5

    Time frame: Baseline to 6 months

  5. Medication adherence assessed by Medication Possession Ratio (MPR)

    Time frame: Baseline to 6 months

  6. 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.

    Time frame: Baseline to 6 months

  7. Change in reactive hyperemia index (RHI)

    Time frame: Baseline to 6 months

  8. Number of Participants with Hospitalizations

    Time frame: Baseline to 6 months

  9. Number of Participants with Emergency Department Visits

    Time frame: Baseline to 6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 months after the start.

Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 28 months is above that.

Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2026
First posted
Aug 19, 2026
StartActual
Aug 1, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07774078
Responsible party
Pr. Semir Nouira (Professor, University of Monastir) — Principal investigator
First posted
Aug 19, 2026
Start date
Aug 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 20, 2026

Study contacts

Nouira Semir
Contact
semir.nouira@rns.tn
0021673106046

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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