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

February 6, 2021 updated by: Zeynep Caferoglu, PhD, TC Erciyes University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
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.
Four hours postprandial period (from fasting to 240 minutes after the test breakfast)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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