Health Trials

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

ConditionsDiabete MellitusTelemonitoring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Monastir

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of diabetes mellitus with HbA1c between 7% and 10%.

Stable antidiabetic treatment for at least 4 weeks prior to enrollment.

Disqualifiers

Serum creatinine >200 µmol/L.

Acute coronary syndrome or stroke.

Dementia.

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Telemonitoring GroupExperimental treatment 1 intervention
Group B: Standard Care GroupActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Monastir

Lead sponsor

Source ClinicalTrials.gov
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