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

Not Applicable

• Conditions: Diabetes Mellitus Type 2; Diabetes Mellitus Type 1
• Interventions: Device: SMARTCLOTH

• Registration Number: NCT06623708
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study Start: 2024-10
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMARTCLOTH	SMARTCLOTH	This group will use SMARTCLOTH for 3 months.

Primary Outcome Measures

Name	Time	Method
glycated hemoglobin	From enrollment to the end of treatment at 3 months	The test shows an average of the blood sugar level over the past 90 days and represents a percentage. The test can also be used to diagnose diabetes

Trial Locations

Locations (5)

Ugc Centro; 🇪🇸 Córdoba, Andalucía, Spain

Ugc Lucano; 🇪🇸 Córdoba, Andalucía, Spain

Ugc Aeropuerto; 🇪🇸 Córdoba, Andalucía, Spain

Ugc Fuensanta; 🇪🇸 Córdoba, Andalucía, Spain

Ugc La Carlota; 🇪🇸 Córdoba, Andalucía, Spain