Defining the relationship between carbohydrate amount and the dose of insuli

• Conditions: Type one Diabetes Mellitus; Hypoglycaemia; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000729426
• Lead Sponsor: Telethon Kids Institiute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percentage of time in glucose target (4 – 10 mmol/L) using a continuous glucose monitoring system. [average data from the five hour post postprandial period on four different days after four different meals will be analysed ]

Secondary Outcome Measures

Name	Time	Method
Hypoglycaemia (defined as less than or equal to 3.9 confirmed upon finger prick) during the five hour postprandial period.[Average data from the five hour post postprandial period on four different days after four different sized meals will be analysed ]