Could the Advanced Hybrid Closed-Loop System Algorithm Provide Postprandial Normoglycemia After a High-Fat, High-Protein Meal

NCT06848933 | Completed FDA Device

• 1 other identifier: AHCLS T1D high fat and protein
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus; Adolescents

Keywords

AHCLS; type 1 diabetes; high fat, high protein; adolescents

Outcome Measures

Primary Outcomes (1)

• time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal

  Percentage of time when blood sugar is at 70-180 mg/dl for pst prandial 5 hours after the test meal

  1 month

Study Arms (1)

Adolescents with type 1 diabetes on Medtronic Minimed 780G

EXPERIMENTAL

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

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

Interventions

Test meal OTHER

On days 1, 2 and 3 of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose monitoring system data and optimize the carbohydrate/insulin ratios. On days 4 and 7 of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose monitoring 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 days 11 and 14 of the study, with the participant's pump 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 the continuous

Adolescents with type 1 diabetes on Medtronic Minimed 780G

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

After the intervention, blood glucose values will be documented from continued glucose measurement system for postprandial 5 hours,and compared in manual mode and auto mode

Adolescents with type 1 diabetes on Medtronic Minimed 780G

Advanced hybrid closed loop system mode DEVICE

On days 1, 2 and 3 of the study, a pediatric endocrinologist from the research team will evaluate the continuous glucose monitoring system data and optimize the carbohydrate/insulin ratios. On days 4 and 7 of the study, participants with blood sugar levels between 70-140 mg/dl according to the continuous glucose monitoring 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 days 11 and 14 of the study, with the participant's pump 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 the continuous

Adolescents with type 1 diabetes on Medtronic Minimed 780G

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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.)

Sponsors & Collaborators

• Ege University: lead
• Izmir Tinaztepe University: collaborator

Study Sites (1)

Ege University, Medical Faculty, Division of Pediatric Endocrinology

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• yasemin atik altınok, Assoc Prof

  İzmir Tınaztepe University

  PRINCIPAL INVESTIGATOR

• Damla Goksen, Prof Dr

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietician, PhD, Assoc Prof

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 27, 2025
• Study Start: January 5, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 20, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

TU (1)