Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623708
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
SMARTCLOTH Design Implementation and Study of the Effectiveness and Usability of a Digital Tablecloth for Self-management of Diet in Diabetic Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SMARTCLOTH Design Implementation and Study of the Effectiveness and Usability of a Digital Tablecloth for Self-management of Diet in Diabetic Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None