Diabete Mellitus, Telemonitoring
Conditions
Brief 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.
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.
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Glucose Level (mmol/L) | 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) (%) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline to 6 months | — |
| Change in body mass index (BMI) | Baseline to 6 months | — |
| Change in urinary albumin concentration measured in mg/L. | Baseline to 6 months | — |
| Medication adherence assessed by MARS-5 | Baseline to 6 months | — |
| Medication adherence assessed by Medication Possession Ratio (MPR) | Baseline to 6 months | — |
| Change in Skin Autofluorescence (AGEs) Measured by AGE Reader | 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. |
| Change in reactive hyperemia index (RHI) | Baseline to 6 months | — |
| Number of Participants with Hospitalizations | Baseline to 6 months | — |
| Number of Participants with Emergency Department Visits | Baseline to 6 months | — |
Countries
Tunisia
Contacts
CONTACTNouira Semir
Outcome results
None listed