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Comparative Study of the Postprandial Glycemic Profile After Consumption of a High-fat Meal (Pizza) Between the Open-loop System (Medtronic MiniMed 640G) and the Hybrid Closed-loop System (Medtronic MiniMed 780G) in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion Pumps.

Sponsor: Konstantinos Makrilakis, MD

Summary

The aim of this interventional clinical study is to compare the postprandial glycemic profile of patients with type 1 diabetes using either an open-loop (Medtronic Minimed 640G) or closed-loop (Medtronic Minimed 780G) insulin pump, after consuming a high-fat meal (pizza). The new advanced Medtronic MiniMed 780G insulin pump (closed hybrid loop) features an advanced algorithm that enables the automatic administration of corrective microdoses of insulin (microboluses) every 5 minutes. The open-loop pump offers the option of a dual-wave bolus pattern for insulin delivery, which is currently considered the best approach for managing such high-fat meals, a feature that is not available in the closed-loop pump. The main questions to answer are: 1. To what extent can the new closed-loop insulin pump with automatic corrective microdoses of insulin manage the late postprandial hyperglycemia caused by a high-fat meal like pizza, which is extremely difficult for type 1 diabetes patients to manage? 2. To what extent should protein and fat, in addition to carbohydrates, be accounted for in patients with type 1 diabetes using the closed-loop pump when consuming high-fat meals like pizza? Participants will be adults (\> 18years old) with type 1 diabetes using the MiniMed 780G pump (with either aspart or lispro insulin) and who are regularly followed up at the Insulin Pump Outpatient Department of the Diabetes Center of the Laiko General Hospital, National and Kapodistrian University of Athens Medical School, in Athens, Greece. They will undergo three study visits. During these visits, different strategies for managing a high-fat meal will be compared using both the closed-loop and open-loop modes of the insulin pump. A brief clinical history will be taken (duration of diabetes, conditions at initial diagnosis, treatment regimen, complications), and anthropometric measurements (height, weight, waist circumference) will be recorded. Data from the insulin pumps will be uploaded to a computer to document the pump's basic settings (insulin-to-carbohydrate ratio, insulin sensitivity factor, hourly basal rates, glucose target, active insulin time), and the most recent HbA1c value will be noted. The meal test will start only if the sensor glucose level upon arrival is below 180 mg/dL. An intravenous catheter will be placed in a forearm vein for repeated blood sampling to measure venous glucose levels at time 0 (pre-meal), 30, 60, 90, 120, 150, 180, 210, and 240 minutes after consuming the meal. At the same times, capillary blood glucose will also be measured, the glucose sensor readings from the pump will be recorded as well. The meal test will then begin, using different meal coverage approaches to be compared.

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