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

August 19, 2026 updated by: Pr. Semir Nouira, University of Monastir

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Monastir, Tunisia
        • Recruiting
        • University Hospital Fattouma Bourguiba Monastir
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of diabetes mellitus with HbA1c between 7% and 10%.
  • Stable antidiabetic treatment for at least 4 weeks prior to enrollment.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Participants in the telemonitoring group receive a connected blood glucose meter, which automatically transmits all blood glucose readings to a dedicated online telemonitoring platform.
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
Standard follow-up will including at least three scheduled study visits at Day 15, Month 3, and Month 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months
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.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Baseline to 6 months
Baseline to 6 months
Change in body mass index (BMI)
Time Frame: Baseline to 6 months
Baseline to 6 months
Change in urinary albumin concentration measured in mg/L.
Time Frame: Baseline to 6 months
Baseline to 6 months
Medication adherence assessed by MARS-5
Time Frame: Baseline to 6 months
Baseline to 6 months
Medication adherence assessed by Medication Possession Ratio (MPR)
Time Frame: Baseline to 6 months
Baseline to 6 months
Change in Skin Autofluorescence (AGEs) Measured by AGE Reader
Time Frame: Baseline to 6 months
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.
Baseline to 6 months
Change in reactive hyperemia index (RHI)
Time Frame: Baseline to 6 months
Baseline to 6 months
Number of Participants with Hospitalizations
Time Frame: Baseline to 6 months
Baseline to 6 months
Number of Participants with Emergency Department Visits
Time Frame: Baseline to 6 months
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • e-DIABISCOPE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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