Actively Recruiting
Adherence to Mediterranean Diet in Type 1 Diabetes Initiating MiniMed 780G Comparing Glucose and Insulin Metrics
Led by Attikon Hospital · Updated on 2025-11-19
240
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients aged over 12 years with Type 1 Diabetes Mellitus (T1DM) who are on multiple daily injections or insulin pumps and are about to start using the MiniMed 780G system. This observational study aims to compare patients' adherence to the Mediterranean Diet before and 12 weeks after starting the MiniMed 780G, and to explore how this relates to glucose monitoring, insulin use, body measurements, blood pressure, lipid levels, and gut microbiome changes. The study also assesses markers of heart and blood vessel function at baseline, six months, and twelve months. Participants will be monitored after a 7-day run-in period where their food intake and adherence to the Mediterranean Diet are recorded using a questionnaire and food diary. Everyone will receive a one-hour session about the Mediterranean Diet and its impact on diabetes before starting the MiniMed 780G system. The study measures various health indicators like HbA1c, continuous glucose monitoring (CGM) and insulin metrics, body composition, blood pressure, lipid levels, and gut microbiome at baseline and after 12 weeks of using the device. Additional heart and vascular markers will be checked at baseline, six, and twelve months, with an extension phase lasting up to one year. During the study, participants will keep detailed food diaries, and researchers will collect data on glucose control, insulin doses, body measurements, and cardiovascular health. The MiniMed 780G system automatically calculates insulin doses based on glucose sensor readings. The study evaluates changes in glucose control measures, insulin dosing, and cardiovascular function over time. Participants are followed closely for one year, with evaluations at several time points to understand the effects of the device and diet adherence on their health.
CONDITIONS
Brief Title
Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of type 1 diabetes for more than 1 year
- HbA1c less than 12.5%
- Age over 7 years at the start of the system
- Using multiple daily insulin injections with total daily insulin use greater than 8.0 units per day over one week
- Clinically able to start the advanced hybrid closed loop system
- History of at least 3 clinic visits in the last year
You will not qualify if you...
- Diabetic ketoacidosis in the 6 months prior to screening visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants complete a 7-day run-in period before starting the MiniMed 780G system.
No visits during this period
Duration - 12 weeks
Participants initiate use of the MiniMed 780G hybrid closed loop system and receive a one hour educational session on the Mediterranean Diet and its impact on diabetes.
Baseline visit and follow-up visits during 12 weeks
Duration - Up to 12 months
Participants are monitored for cardiovascular and endothelial function and other health markers up to one year after starting the MiniMed 780G system.
Visits at 6 months and 12 months, with an extension phase including visits at 3 and 6 months post 12-week period
Trial Site Locations
Total: 1 location
1
Attikon University General Hospital
Chaïdári, Greece, 124 62
Actively Recruiting
Research Team
V
VAIA LAMBADIARI, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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