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

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

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 Overview

• Status: Completed
• Conditions: Insulin-Dependent Diabetes Mellitus 1
• Intervention / Treatment: Other: High GI calculated by CC (CHGI); Other: Low GI calculated by CC (CLGI); Other: High GI calculated by FII (FHGI); Other: Low GI calculated by FII (FLGI)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Erciyes University Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbohydrate Counting; The insulin doses of the breakfasts were calculated according to carbohydrate counting.	Other: High GI calculated by CC (CHGI); 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.; Other: Low GI calculated by CC (CLGI); 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.
Experimental: Food Insulin Index; The insulin doses of the breakfasts were calculated according to food insulin index.	Other: High GI calculated by FII (FHGI); 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.; Other: Low GI calculated by FII (FLGI); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glucose response by glucometer	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, 30, 60, 90, 120, 150, 180, 210 and 240 minutes.	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.	Four hours postprandial period (from fasting to 240 minutes after the test breakfast)

Collaborators and Investigators

• Sponsor: TC Erciyes University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): November 24, 2019
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Adolescent; Type 1 diabetes; Glycemic Index; Carbohydrate Counting; Food Insulin Index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 8811 (Other Identifier: CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No