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

Launched by MAIMÓNIDES BIOMEDICAL RESEARCH INSTITUTE OF CÓRDOBA · Sep 30, 2024

Keywords

ClinConnect Summary

This study is testing SMARTCLOTH, a digital tablecloth that weighs the food you plan to eat and records its nutrition to help people with diabetes follow recommended eating patterns more closely. By comparing two groups over 3 months, researchers want to see if using SMARTCLOTH improves blood sugar control (measured by a test called HbA1c, which shows average sugar levels over about the last 3 months) and whether people find the device useful in daily life. One group will use SMARTCLOTH, while the other group follows standard diet advice.

Who can participate? Adults aged 18–70 with either Type 1 or Type 2 diabetes, with diabetes for up to 15 years and an HbA1c above 7.5%. Exclusions include factors that could make it hard to follow the study or protect safety, such as significant physical or mental limitations, certain other illnesses, or specific dietary restrictions. The study is conducted in Córdoba, Spain, and is currently enrolling by invitation. Participants will either use SMARTCLOTH for 3 months or receive usual care and will have a follow-up visit at the end of the study period to review their health measures. If the device has any problems, participants are asked to contact the study team.

Gender

ALL

Eligibility criteria

• • 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.