Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference

Launched by ATTIKON HOSPITAL · Oct 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well patients with type 1 diabetes stick to a Mediterranean diet after starting a new insulin management system called MiniMed 780G. The trial will include 240 participants aged 12 and older who have been diagnosed with type 1 diabetes for over a year and use insulin injections or a pump. Researchers want to see how following the Mediterranean diet affects various health markers, such as blood sugar levels, body weight, and heart health, both before and 12 weeks after starting the MiniMed 780G system.

To be eligible for this study, participants must have a certain level of diabetes control (an HbA1c of less than 12.5%), be using more than 8 units of insulin daily, and have had at least three clinic visits in the last year. Those with a recent history of serious diabetes complications, like diabetic ketoacidosis, won't be able to participate. If you join this trial, you can expect to track your diet and health metrics over several months, helping researchers understand the benefits of diet on diabetes management.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical diagnosis of type 1 diabetes \>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
• • 2. HbA1c \< 12.5%
• • 3. Age \>7years at the initiation of the system
• • 4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period
• • 5. Clinically able to start the AHCL system
• • 6. History of 3 clinic visits in the last year
• Exclusion Criteria:
• • 1. Diabetic Ketoacidosis in the 6 months prior to screening visits
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