NCT06623708

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus Type 2
• Diabetes Mellitus Type 1

Interventions

Type	Name	Description
DEVICE	SMARTCLOTH	The intervention consists of using SMARTCLOTH. This device makes it possible to monitor dietary intake throughout the day and record it in a database that, through a website, allows to track it. SMARTCLOTH is a digital tablecloth consisting of a scale, several buttons and a screen. The device allows weighing the food to be consumed and recording its nutritional value (macronutrients in grams, macronutrient servings and kilocalories). The latter is achieved because SMARTCLOTH allows the patient to select to which food group the food being weighed belongs, increasing the accuracy of the nutritional estimation.

Timeline

• Start date: 2024-10-01
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2024-10-02
• Last updated: 2024-10-02

Locations

5 sites across 1 country: Spain