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Defining the relationship between carbohydrate amount and the dose of insulin

Defining the relationship between carbohydrate quantity and the dose of subcutaneous insulin.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000729426
Enrollment
40
Registered
2016-06-02
Start date
2016-06-20
Completion date
2016-11-21
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Patients with type one diabetes typically carbohydrate count and use an insulin to carbohydrate ratio (ICR) to dose their insulin. This ratio assumes a linear relationship between carbohydrate quantities to be consumed and the insulin required to maintain blood sugar levels after a meal. Recent research and reports from families with type 1 diabetes raise the question of the validity of this linear model. This study aims to define the relationship between carbohydrate quantity and the dose of subcutaneous insulin. More specifically, to demonstrate that the current linear ICR approach is too steep resulting in increased events of low blood sugar levels as the carbohydrate content increases. This research project will analyse the response of blood glucose levels after a predominantly carbohydrate based meal. Forty participants between 12 -30 years of age, with type one diabetes on intensive insulin therapy will be recruited. Participants will be fitted with a continuous glucose monitoring system (CGMS). Insulin dose will be calculated using the standard linear ICR using study liquid-meals of 20, 50, 100 and 150g of carbohydrate controlled with similar proportions of fats and protein on four consecutive days (one per day). CGMS data will be analysed to determine whether the relationship between carbohydrate intake and insulin requirements is indeed linear. It is hoped this study will provide important information in the management of type 1 diabetes in both adults and children. Results will assist in building on planned future studies of trialing a non-linear ICR if the hypothesis is supported. This research will be used in our day to day management of patients and guide the development of clinical guidelines to help minimise the occurrence of hypoglycaemia and blood glucose fluctuations after eating.

Interventions

This research project will analyse the response of glucose levels after a predominantly carbohydrate based meal. Forty participants between 12 -30 years of age, with type one diabetes on intensive insulin therapy will be recruited. Participants will be fitted with the Animas G4 continuous glucose monitoring system (CGMS). Insulin dose will be calculated using the standard linear insulin to carb ratio for meals of 20, 50, 100 and 150g of carbohydrate, standardised for % of energy from carbohydrat

This research project will analyse the response of glucose levels after a predominantly carbohydrate based meal. Forty participants between 12 -30 years of age, with type one diabetes on intensive insulin therapy will be recruited. Participants will be fitted with the Animas G4 continuous glucose monitoring system (CGMS). Insulin dose will be calculated using the standard linear insulin to carb ratio for meals of 20, 50, 100 and 150g of carbohydrate, standardised for % of energy from carbohydrates, fat, protein. The planned meal will be a standard pancake recipe with a sucrose based topping for all four carbohydrate quantities with the carbohydrates coming mostly from flour, sugar and milk. Prior to commencement of the study participants will complete a 1 - 2 week run-in period where their control and insulin to carb ratio will be optimised through telephone contact with the diabetes team. They will then attend a short approx half an hour visit to the research department at the hospital to be fitted and explained the CGMS. The next day following the fitting of the CGMS the participant will then either attend the hospital or researchers will attend the participants home 4 mornings in a row to prepare the study meal, supervise insulin administration and meal consumption. The total required length of including the run in period will be 2 -3 weeks and approximately 1 -2 hours per day. Insulin will be administered in their usual way (injection or pump) and sedentary activities and fasting will be undertaken unless food is required for hypoglycaemia in the 5 hours following meal consumption. The CGMS data from this post postprandial period will subsequently be analysed by researchers to determine whether the currently standard practice of using an insulin to carbohydrate ratio is effective across a range of sized carbohydrate meals.

Sponsors

Telethon Kids Institiute
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
12 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

Patients will have been diagnosed with T1DM for >/= one year Insulin pump or multiple daily injections using an ICR for >/= 6 months HbA1c of < /= 8% Non-obese weight (< /=97th %ile for children, BMI <30kg/m2 for adults)

Exclusion criteria

Any pre-existing complications of diabetes, such as gastroparesis Any co existing food intolerances, allergies and medical conditions such as coeliac disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026