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

Not Applicable

Completed

• Conditions: Insulin-Dependent Diabetes Mellitus 1
• Interventions: Other: High GI calculated by FII (FHGI); Other: High GI calculated by CC (CHGI); Other: Low GI calculated by FII (FLGI); Other: Low GI calculated by CC (CLGI)

• Registration Number: NCT04131049
• Lead Sponsor: TC Erciyes University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-24
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-18
• Primary Completion: 2019-11-24
• Study Completion: 2020-01-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-06
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Food Insulin Index	High GI calculated by FII (FHGI)	The insulin doses of the breakfasts were calculated according to food insulin index.
Food Insulin Index	Low GI calculated by FII (FLGI)	The insulin doses of the breakfasts were calculated according to food insulin index.
Carbohydrate Counting	High GI calculated by CC (CHGI)	The insulin doses of the breakfasts were calculated according to carbohydrate counting.
Carbohydrate Counting	Low GI calculated by CC (CLGI)	The insulin doses of the breakfasts were calculated according to carbohydrate counting.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Erciyes University Faculty of Health Sciences; 🇹🇷 Kayseri, Turkey