Clinical trial NCT06848933: Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal
Official title: Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Adolescents
Keywords: AHCLS
type 1 diabetes
high fat, high protein
adolescents
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Izmir Tinaztepe University
First posted: 2025-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University, Medical Faculty, Division of Pediatric Endocrinology
state: Bornova
Study officials:
affiliation: İzmir Tınaztepe University
name: yasemin atik altınok, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Damla Goksen, Prof Dr
role: STUDY_DIRECTOR
References: