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NCT Number: NCT07774078

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

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.

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Key information

Conditions

Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Telemonitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Fattouma Bourguiba Monastir

Monastir, Tunisia

Location status: Recruiting

Location contact

Nouira Semir, Professor

CONTACT

[email protected]

0021673106046

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemonitoring group

Device

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 Group

Other

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

Primary outcomes

  1. 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.

  2. 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.

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

    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.

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Nouira Semir

CONTACT

[email protected]

0021673106046

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

Evaluation of the Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Tunisian Patients With Diabetes Mellitus: a Study Protocol

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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