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Clinical Trials/NCT06848933
NCT06848933CompletedNot Applicable

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

Ege University1 site in 1 country20 target enrollmentStarted: January 5, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
9 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.)

Arms & Interventions

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

Intervention: Test meal (Other)

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

Intervention: 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)

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

Intervention: Advanced hybrid closed loop system mode (Device)

Outcomes

Primary Outcomes

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

Time Frame: 1 month

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasemin Atik Altinok

Dietician, PhD, Assoc Prof

Izmir Tinaztepe University

Study Sites (1)

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