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

NCT06623708 | Enrolling By Invitation

• 1 other identifier: PI21/01602
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

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.

Conditions

Diabetes Mellitus Type 2; Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

• glycated hemoglobin

  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

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Control

NO INTERVENTION

This group of participants should follow the general recommendations for the management of Type 1 or Type 2 Diabetes.

SMARTCLOTH

EXPERIMENTAL

This group will use SMARTCLOTH for 3 months.

Device: SMARTCLOTH

Interventions

SMARTCLOTH DEVICE

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.

SMARTCLOTH

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (5)

Ugc Centro

Córdoba, Andalusia, 14001, Spain

Location

Ugc Lucano

Córdoba, Andalusia, 14003, Spain

Location

Ugc Aeropuerto

Córdoba, Andalusia, 14004, Spain

Location

Ugc Fuensanta

Córdoba, Andalusia, 14010, Spain

Location

Ugc La Carlota

Córdoba, Andalusia, 14100, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)