Comparison of Two Different Insulin Dose Calculation Algorithms in Type 1 Diabetes
NCT ID: NCT04131049
Last Updated: 2021-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2019-06-24
2020-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SCREENING
SINGLE
Study Groups
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Carbohydrate Counting
The insulin doses of the breakfasts were calculated according to carbohydrate counting.
High 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.
Low 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.
Food Insulin Index
The insulin doses of the breakfasts were calculated according to food insulin index.
High 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.
Low 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.
Interventions
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High 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.
Low 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.
High 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.
Low 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
18 Years
ALL
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Zeynep Caferoglu, PhD
Assistant Professor Doctor
Locations
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Erciyes University Faculty of Health Sciences
Kayseri, , Turkey (Türkiye)
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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8811
Identifier Type: -
Identifier Source: org_study_id
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