Insulin-Dependent Diabetes Mellitus 1
Conditions
Keywords
Adolescent, Carbohydrate Counting, Food Insulin Index, Glycemic Index, Type 1 diabetes
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).
Interventions
OTHERHigh 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.
OTHERLow 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.
OTHERHigh 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.
OTHERLow 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.
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed