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Food Insulin Index (FII) versus Traditional Carbohydrate Counting for Glycemic Control in Adults with Type 1 Diabetes.

Food Insulin Index (FII) versus Traditional Carbohydrate Counting for Glycemic Control in Adults with Type 1 Diabetes.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001367730
Acronym
FOODII
Enrollment
26
Registered
2013-12-13
Start date
2013-05-21
Completion date
2013-09-09
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this parallel randomised controlled study in individuals with type 1 diabetes, we will compare two methods of adjusting the dose of insulin to match the nutrients in a meal. One method, known as carbohydrate counting, uses an algorithm (= formula) that matches the dose of insulin to the carbohydrate content of the meal. The second method uses a novel algorithm based on the food’s normal insulin response in healthy subjects (the Food Insulin Index or FII). Participants will be randomised to either the carbohydrate counting or FII intervention group and will receive education regarding the practical implementation of their corresponding algorithm. Glycosylated haemoglobin (HbA1c) and postprandial glycaemia and the occurrence of hypoglycaemia (recorded using a Continuous Glucose Monitoring System, CGMS) will be compared at baseline and after 3 months. We hypothesize that using the novel FII to adjust mealtime insulin dose will improve blood glucose control, compared with carbohydrate counting.

Interventions

In this 3 month, parallel randomised controlled study in individuals with type 1 diabetes, we will compare two methods of adjusting the dose of insulin to match the nutrients in a meal. The intervention group will use a novel algorithm based on the food’s normal insulin response in healthy subjects (the Food Insulin Index or FII). Participants randomised to the FII intervention group will received 1x 2hr group education workshop, including presentation & discussion of relevant information, dem

In this 3 month, parallel randomised controlled study in individuals with type 1 diabetes, we will compare two methods of adjusting the dose of insulin to match the nutrients in a meal. The intervention group will use a novel algorithm based on the food’s normal insulin response in healthy subjects (the Food Insulin Index or FII). Participants randomised to the FII intervention group will received 1x 2hr group education workshop, including presentation & discussion of relevant information, demonstration & practical activities on using FII counting and estimating food portion sizes; and 1x 30min individual appointment to reinforce the education and apply FII counting to individual food choices/preferences (note: diet not provided - subjects continue normal eating patterns). All education sessions will be delivered by an Accredited Practising Dietitian. Participants will be given a written education materials (pictorial reference book, pocket-sized reference book and session manual) and access to the study website and an iPhone app. Subjects are emailed weekly throughout the 3 month trial to see how they are going with the FII counting and offer assistance if needed. Glycosylated haemoglobin (HbA1c) and postprandial glycaemia and the occurrence of hypoglycaemia (recorded using a Continuous Glucose Monitoring System, CGMS) will be compared at baseline and after 3 months. We hypothesize that using the novel FII to adjust mealtime insulin dose will improve blood glucose control, compared with carbohydrate counting.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. age 18 - 65 years 2. type I diabetes diagnosed for 1 year or more 3. proficiency with bolus dose calculations (either manually or using insulin pump bolus calculator) 4. recent glycated hemoglobin level (a long term measure of diabetes control) between 7.0 to 9.5 % 5. reliably performing self-monitoring of blood glucose at least four times daily 6. able to speak and understand English fluently

Exclusion criteria

1. pregnancy or lactation 2. mental impairments or disorders 3. eating disorders 4. medication that may influence blood glucose profile

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026