Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal (AHCLS T1D nutr)

Ege University

Status: Completed

Conditions: Adolescents; Type 1 Diabetes Mellitus

Treatments: Device: Advanced hybrid closed loop system mode; Device: Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode; Other: Test meal

Study type: Interventional

Funder types: Other

Identifiers

NCT06848933

AHCLS T1D high fat and protein

Details and patient eligibility

About

AHCL Systems Could Cover Postprandial Glycemic Response After High Fat and High Protein Meals

Full description

On the 1st, 2nd and 3rd day of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose measurement system data and optimize the carbohydrate/insulin ratios. On the 4th and 7th days of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose measurement system, which is a component of the hybrid closed-loop insulin infusion pump system, will consume the test meal consisting of Dr Oetker Ristorante Pizza Mista (340 grams) (92 g carbohydrate, 33 g protein, 41 g fat) at lunch, under the supervision of a dietician from the research team, by switching the pump to manual mode and entering the carbohydrate amount of the meal into the pump. This application will be repeated on the 11th and 14th days of the study while the participant's pump is in automatic mode. Participants will not be allowed to consume food or beverages other than water or exercise for 5 hours after the meal. Blood sugar monitoring will be done with a continuous glucose measurement system. The participant will leave the hospital 5 hours after the start of the meal to return to their normal life. Dr Oetker Ristorante Pizza Mista, which was selected as the test meal, was chosen because it is a macronutrient content that is consumed by young people between the ages of 9-18 and that is similar to the test meals in the world literature and accepted research reports reporting the effect of high-fat and high-protein meals on glycemic response in individuals with diabetes.

Enrollment: 20 patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Volunteering to participate in the study
• Not having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)

Exclusion criteria

• • Not volunteering to participate in the study
• Using psychiatric medication or any medication that may cause obesity at the time of trial
• Having a disease accompanying type 1 diabetes (celiac, cystic fibrosis, etc.)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Adolescents with type 1 diabetes on Medtronic Minimed 780G

Experimental group

Description:

Each participant will consume the test meal in Medtronic Minimed 780Gmanual mode and Medtronic Minimed 780G in auto mode. Each participant will be in control of himself/herself

Treatment:

Other: Test meal

Device: Each participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode

Device: Advanced hybrid closed loop system mode