Clinical trial NCT04131049: Comparison of Two Different Insulin Dose Calculation Algorithms in Type 1 Diabetes
Official title: Comparison of Carbohydrate Counting and Food Insulin Index Methods in the Determination of Insulin Doses for High- and Low-Glycemic Index Meals in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin-Dependent Diabetes Mellitus 1
Keywords: Adolescent
Carbohydrate Counting
Food Insulin Index
Glycemic Index
Type 1 diabetes
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 15
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The aim of this study is to compare the impact of carbohydrate counting (CC) method which is standard insulin dose calculation algorithm and food insulin index (FII) method which is a new algorithm on postprandial glucose following a high fat and a high protein meal in adolescent with type 1 diabetes. A randomized, single-blind and crossover trial included 14 adolescents aged 14-18 years with type 1 diabetes. All participants were sent to their homes for 4 consecutive days with a different glycemic index breakfast. The insulin doses of the meals were calculated according to CC and FII methods. Test breakfasts with different GIs and insulin requirements calculated with different algorithms are as follows: High GI calculated by CC (CHGI), low GI calculated by CC (CLGI), high GI calculated by FII (FHGI) and low GI calculated by FII (FLGI).


Eligibility criteria: Inclusion Criteria:

* Aged between 14-18 years adolescents
* Type 1 diabetes diagnosed for at least one year
* Performing self-monitoring of blood glucose and doses of insulin at least four times daily
* HbA1c ≤ 9.6% for the last three months
* Negative fasting C-peptide (\<0.1 nmol/L)
* Total daily insulin use of ≥ 0.5 U/kg
* World Health Organization BMI/age z-score of -1 to below 3

Exclusion Criteria:

* Complications of diabetes or other medical conditions including celiac disease
* Treatment with oral hypoglycaemic agents
* Food allergies, intolerances, or eating disorder
* Intestinal malabsorptions
* Delayed gastric emptying
* Viral or bacterial infection
* Physical or mental disability
* Clinical condition related to impaired digestive system such as cystic fibrosis

Primary outcomes:
measure: Postprandial glucose response by glucometer
timeFrame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
measure: Postprandial glucose response by continous glucose monitoring
timeFrame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Health Sciences
Study officials:
References:
citation: Erdal B, Caferoglu Z, Hatipoglu N. The comparison of two mealtime insulin dosing algorithms for high and low glycaemic index meals in adolescents with type 1 diabetes. Diabet Med. 2021 Mar;38(3):e14444. doi: 10.1111/dme.14444. Epub 2020 Dec 20.