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Completed

NCT Number: NCT04131049

Comparison of Two Different Insulin Dose Calculation Algorithms in 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).

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Key information

Conditions

Insulin-Dependent Diabetes Mellitus 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Health Sciences

Kayseri, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High GI calculated by CC (CHGI)

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 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.

Primary outcomes

  1. Postprandial glucose response by glucometer

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

    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.

  2. Postprandial glucose response by continous glucose monitoring

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

    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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 18, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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