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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ugc Centro | Córdoba | Andalusia | 14001 | Spain | ||
| Ugc Lucano |
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|
| Córdoba |
| Andalusia |
| 14003 |
| Spain |
| Ugc Aeropuerto | Córdoba | Andalusia | 14004 | Spain |
| Ugc Fuensanta | Córdoba | Andalusia | 14010 | Spain |
| Ugc La Carlota | Córdoba | Andalusia | 14100 | Spain |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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