SMARTCLOTH. Design, Implementation and Study of the Effectiveness and Usability of a Digital Tablecloth for Self-management of Diet in Diabetic Patients.

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 70 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

90 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The objective of this clinical trial is to know the usability and efficacy of SMARTCLOTH for better control and adherence to the dietary patterns recommended to patients with diabetes, both the portion diet system (more common for cases of Diabetes Mellitus type 1 -DM1-), and the plate method (more recommended in cases of Diabetes Mellitus type 2-DM2-). The main questions are:

• Does the use of SMARTCLOTH improve glycemic control in patients with diabetes mellitus?
• Do patients with diabetes mellitus find SMARTCLOTH useful in their daily lives?

The researchers will compare changes over 3 months in variables related to glycemic control in two groups, one using SMARTCLOTH (intervention group) and the other following standard recommendations (control group). To do so, participants will have to:

• Use SMARTCLOTH for 3 months or follow the recommendations they receive from their referring health professionals.
• Come back after three months for a check-up of the chosen variables.
• The experimental group should contact the investigators in case the hardware has any problems.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria: Subjects with type 1 and 2 diabetes (eligible population) aged between 18 and 70 years with disease progression not exceeding 15 years and HbA1c greater than 7.5.

Exclusion Criteria:

• Degree of dependence (physical or psychological) that makes it impossible for them to perform autonomous self-care of the dietary-nutritional regimen.
• Oncological or autoimmune disease, chronic renal insufficiency, transplant patients and others that alter the values of the result variables or may constitute a confounding factor.
• Other diseases that entail surgical interventions or hospital admissions that make it impossible to follow up the study.
• Patients with complications due to the evolution of the diabetic pathology: retinopathy, nephropathy, polyneuropathy, ischemic heart disease, as well as other micro and macrovascular complications derived from the same and already recorded in the patient.
• Those subjects subjected to specific dietary regimes such as celiac disease, lactose intolerant, etc.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not randomized

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (5)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

5 locations

Study team and timeline

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Study start

May 2, 2025 Actual

Primary completion

2027-10 Estimated

Study completion

2027-10 Estimated

First posted

Oct 2, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.