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

TC Erciyes University

Status: Completed

Conditions: Insulin-Dependent Diabetes Mellitus 1

Treatments: Other: Low GI calculated by FII (FLGI); Other: High GI calculated by CC (CHGI); Other: High GI calculated by FII (FHGI); Other: Low GI calculated by CC (CLGI)

Study type: Interventional

Funder types: Other

Identifiers

NCT04131049

8811 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 15 patients

Sex: All

Ages: 14 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Carbohydrate Counting

Experimental group

Description:

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

Treatment:

Other: High GI calculated by CC (CHGI)

Other: Low GI calculated by CC (CLGI)

Food Insulin Index

Experimental group

Description:

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

Treatment:

Other: High GI calculated by FII (FHGI)

Other: Low GI calculated by FII (FLGI)