Effect of prandial status on capillary - venous glucose gradient in type 1 diabetes

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613001162707
• Date of registration: 21/10/2013
• Prospective Registration: Yes
• Primary sponsor: Dr Helen Lunt
• Public title: Effect of prandial status on capillary - venous glucose gradient in type 1 diabetes
• Scientific title: Effect of prandial status on [capillary-venous] glucose difference, in participants with well controlled type 1 diabetes
• Date of first enrolment: 18/11/2013
• Target sample size: 40
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12613001162707.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: Dr Helen Lunt

• Name: Dr Helen Lunt

Key inclusion & exclusion criteria

Inclusion criteria: Type 1 diabetes, HbA1c <65mol/mol, on CSII or MDI insulin, ability to estimate insulin:carbohydrate ratio
Exclusion criteria: Pregnancy

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Type 1 diabetes;
Type 1 diabetes

Intervention(s)

Capillary and venous glucose responses will be measured one hour and two hours after a buffet breakfast, the content of which is selected by participants. Total period of observation is two hours.

Primary Outcome(s)

[Capillary -venous] glucose gradient, at the two hour post prandial time point. Duplicate capillary and venous glucose measurements will be assessed using two meter/strip systems with differing enzyme systems, namely the Nova StatStrip and the Accu-chek Performa. Venous plasma glucose will also undergo rapid plasma separation using a PST tube, followed by laboratory measurement using the hexakinase method and this venous value will be used as an ancillary measure of [capillary-venous] difference.
[Two hours]

Secondary Outcome(s)

[Capillary -venous] glucose gradient, at the one hour post prandial time point. Assessment of glucose is otherwise identical to that of the primary outcome (StatStrip and Performa glucose meters used to measure both capillary and venous samples,with a further check of venous glucose, undertaken by measuring plasma glucose in the laboratory). [One hour]

Secondary ID(s)

none

Source(s) of Monetary Support

Diabetes Christchurch

Secondary Sponsor(s)

University of Otago Christchurch

Ethics review

Status: Approved
Approval date:
Contact:

Health and Disability Ethics Committee