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

Sponsor

TC Erciyes University (Other)

Overall Status

Completed

CT.gov ID

NCT04131049

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Insulin-Dependent Diabetes Mellitus 1	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)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

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

Actual Study Start Date :

Jun 24, 2019

Actual Primary Completion Date :

Nov 24, 2019

Actual Study Completion Date :

Jan 24, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Postprandial glucose response by glucometer [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.
Postprandial glucose response by continous glucose monitoring [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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