Diabetes Mellitus Type 2NCT06623708
SMARTCLOTH. Design, Implementation and Study of the Effectiveness and Usability of a Digital Tablecloth for Self-management of Diet in Diabetic Patients.
A study testing SMARTCLOTH in people with Diabetes Mellitus Type 2 and Diabetes Mellitus Type 1, run by Maimónides Biomedical Research Institute of Córdoba at 5 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Diabetes Mellitus Type 1
- What is being tested?
- SMARTCLOTH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesSpain
- Study dates
- Oct 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Ugc Centro
Córdoba, Andalusia, 14001
Ugc Lucano
Córdoba, Andalusia, 14003
Ugc Aeropuerto
Córdoba, Andalusia, 14004
Ugc Fuensanta
Córdoba, Andalusia, 14010
Ugc La Carlota
Córdoba, Andalusia, 14100
About this study
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?
Read more
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
- Being tested
- SMARTCLOTH
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTCLOTHDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SMARTCLOTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623708
- Sponsor's protocol ID
- PI21/01602
- Status last verified
- Mar 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMARTCLOTH. Design, Implementation and Study of the Effectiveness and Usability of a Digital Tablecloth for Self-management of Diet in Diabetic Patients.
- ClinicalTrials.gov ID
- NCT06623708
- Acronym / sponsor ID
- PI21/01602
- Conditions
- Diabetes Mellitus Type 2, Diabetes Mellitus Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group of participants should follow the general recommendations for the management of Type 1 or Type 2 Diabetes. |
| SMARTCLOTH | Experimental | Device: SMARTCLOTHThis group will use SMARTCLOTH for 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMARTCLOTHThe 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. | Device | SMARTCLOTH |
Primary outcome
glycated hemoglobin
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus Type 2
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMARTCLOTH in people with Diabetes Mellitus Type 2 and Diabetes Mellitus Type 1, run by Maimónides Biomedical Research Institute of Córdoba at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycated hemoglobin (time frame: From enrollment to the end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.