Adolescents, Type 1 Diabetes Mellitus
Conditions
Keywords
AHCLS, type 1 diabetes, high fat, high protein, adolescents
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.
Interventions
OTHERTest meal
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
DEVICEEach participant will consume the test meal when on Medtronic Minimed 780G and will consume test meal on Medtronic Minimed 780G on manual mode
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
DEVICEAdvanced hybrid closed loop system mode
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
Sponsors
Izmir Tinaztepe University
Ege University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time spend in time in range (70-180 mg/dl) for postprandial 5 hours after the test meal | 1 month | Percentage of time when blood sugar is at 70-180 mg/dl for pst prandial 5 hours after the test meal |
Countries
Turkey (Türkiye)
Outcome results
None listed