Comparison of Two Different Insulin Dose Calculation Algorithms in Type 1 Diabetes

TC Erciyes University15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

Conditions

Insulin-Dependent Diabetes Mellitus 1

Interventions

This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.

Low GI calculated by CC (CLGI)OTHER

This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.

High GI calculated by FII (FHGI)OTHER

This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.

Low GI calculated by FII (FLGI)OTHER

This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Erciyes University Faculty of Health Sciences

Kayseri, Turkey (Türkiye)

Outcomes

Primary Outcomes

Postprandial glucose response by glucometer

Time frame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)

Postprandial glucose response by continous glucose monitoring

Postprandial glucose response was quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which was calculated according to the trapezoidal rule by using blood glucose values at time points 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 205, 210, 215, 220, 225, 230, 235 and 240 minutes.

Time frame: Four hours postprandial period (from fasting to 240 minutes after the test breakfast)

Data from ClinicalTrials.gov

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