Comparison of Two Different Insulin Dose Calculation Algorithms in Type 1 Diabetes
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
1 other identifier
interventional
15
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 24, 2019
CompletedFirst Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2020
CompletedFebruary 9, 2021
February 1, 2021
5 months
October 16, 2019
February 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (2)
Carbohydrate Counting
EXPERIMENTALThe insulin doses of the breakfasts were calculated according to carbohydrate counting.
Food Insulin Index
EXPERIMENTALThe insulin doses of the breakfasts were calculated according to food insulin index.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University Faculty of Health Sciences
Kayseri, 38039, Turkey (Türkiye)
Related Publications (1)
Erdal B, Caferoglu Z, Hatipoglu N. The comparison of two mealtime insulin dosing algorithms for high and low glycaemic index meals in adolescents with type 1 diabetes. Diabet Med. 2021 Mar;38(3):e14444. doi: 10.1111/dme.14444. Epub 2020 Dec 20.
PMID: 33119135DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor Doctor
Study Record Dates
First Submitted
October 16, 2019
First Posted
October 18, 2019
Study Start
June 24, 2019
Primary Completion
November 24, 2019
Study Completion
January 24, 2020
Last Updated
February 9, 2021
Record last verified: 2021-02