Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 11:33 PM
Study NCT ID:
NCT06848933
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2024-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AHCLS T1D nutr
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: