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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Insulin-Dependent Diabetes Mellitus 1

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbohydrate Counting<br>The insulin doses of the breakfasts were calculated according to carbohydrate counting. | Other: High GI calculated by CC (CHGI)<br>* 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.<br>Other: Low GI calculated by CC (CLGI)<br>* 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.<br>|
| Experimental: Food Insulin Index<br>The insulin doses of the breakfasts were calculated according to food insulin index. | Other: High GI calculated by FII (FHGI)<br>* 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.<br>Other: Low GI calculated by FII (FLGI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Carbohydrate Counting, Food Insulin Index, Glycemic Index, Type 1 diabetes