Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646107
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G Glucose Metrics vs Insulin Metrics is There a Difference
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G Glucose Metrics vs Insulin Metrics is There a Difference
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
In this observaltional study 240 patients aged 12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system will be includedWe aim to compare patients adherence to Mediterranean diet MD before and 12 weeks after initiation of MiniMed 780G and its association with CGM and insulin metrics as well as anthropometric measurements BMI body composition lipid levels blood pressure and gut microbioma Moreover at baseline at six and 12 months markers of endothelial and cardiovascular function will be also assessed and associated with the use of Minimed 780G and the adherence to MD
Detailed Description:
This observational study will include 240 participants 80 participants per country from IGI region Italy Greece and Israel children adolescents and young adults 12 years old with T1D that are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system After a 7-day run-in period participants will be evaluated with food intake log and adherence to Meditteranean Diet MD with PREDIMED questionnaire One hour session on MD and healthy impact on Diabetes will be provided to all participants and will be assigned to initiate MiniMed 780G and followed for 12 weeks HbA1c CGM and Insulin Metrics anthropometric measurements body composition blood pressure and lipid leves as well a gut microbioma will be performed at baseline and 12 weeks after MiniMed 780G initiation A 7-day food diary logbook will be collected to identify the amount and type of the food at baseline and at the end of the study At baseline at 6 and at 12 months markers of endothelial and cardiovascular function will also be assessed An extension phase will include additional 3 and 6 which concludes one year of follow-up
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