Diabetes Mellitus Type 1, Diabetes Mellitus Type 2
Conditions
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.
Interventions
DEVICESMARTCLOTH
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.
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed