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

Insulin-Dependent Diabetes Mellitus 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131049
• Other study ID #: 8811
• Status: Completed
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: January 24, 2020

Study information

• Verified date: February 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 24, 2020
• Est. primary completion date: November 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin-Dependent Diabetes Mellitus 1

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Erciyes University Faculty of Health Sciences	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)