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

Primary Purpose

Insulin-Dependent Diabetes Mellitus 1

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High GI calculated by CC (CHGI)
Low GI calculated by CC (CLGI)
High GI calculated by FII (FHGI)
Low GI calculated by FII (FLGI)
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Insulin-Dependent Diabetes Mellitus 1 focused on measuring Adolescent, Carbohydrate Counting, Food Insulin Index, Glycemic Index, Type 1 diabetes

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erciyes University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Carbohydrate Counting

Food Insulin Index

Arm Description

The insulin doses of the breakfasts were calculated according to carbohydrate counting.

The insulin doses of the breakfasts were calculated according to food insulin index.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2019
Last Updated
February 6, 2021
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT04131049
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
November 24, 2019 (Actual)
Study Completion Date
January 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin-Dependent Diabetes Mellitus 1
Keywords
Adolescent, Carbohydrate Counting, Food Insulin Index, Glycemic Index, Type 1 diabetes

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbohydrate Counting
Arm Type
Experimental
Arm Description
The insulin doses of the breakfasts were calculated according to carbohydrate counting.
Arm Title
Food Insulin Index
Arm Type
Experimental
Arm Description
The insulin doses of the breakfasts were calculated according to food insulin index.
Intervention Type
Other
Intervention Name(s)
High GI calculated by CC (CHGI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low GI calculated by CC (CLGI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High GI calculated by FII (FHGI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low GI calculated by FII (FLGI)
Intervention Description
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 Outcome Measure Information:
Title
Postprandial glucose response by glucometer
Description
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.
Time Frame
Four hours postprandial period (from fasting to 240 minutes after the test breakfast)
Title
Postprandial glucose response by continous glucose monitoring
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Erciyes University Faculty of Health Sciences
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
33119135
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.
Results Reference
derived

Learn more about this trial

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

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