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Trial registered on ANZCTR


Trial ID
ACTRN12613001162707
Ethics application status
Approved
Date submitted
10/10/2013
Date registered
21/10/2013
Date last updated
11/02/2016
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 283326 0
none
Universal Trial Number (UTN)
U1111-1148-9772
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 290220 0
Condition category
Condition code
Metabolic and Endocrine 290610 290610 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 288051 0
Not applicable
Comparator / control treatment
Within participant comparison of basal (fasting) [capillary-venous] glucose gradient, with the post prandial [capillary-venous] glucose gradient.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290625 0
[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.
Timepoint [1] 290625 0
Two hours
Secondary outcome [1] 304926 0
[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).
Timepoint [1] 304926 0
One hour

Eligibility
Key inclusion criteria
Type 1 diabetes, HbA1c <65mol/mol, on CSII or MDI insulin, ability to estimate insulin:carbohydrate ratio
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Previous studies in healthy volunteers suggest that a minimum number to detect a significant [capillary - venous] glucose gradient is around 12 participants. It is anticipated that this gradient will be attenuated in the present of diabetes, hence the larger number of participants. The primary outcome is descriptive, however if a gradient is found, this will be correlated with a) breakfast insulin dose (u/kg) b) macronutrient intake of meal (breakfast) c) baseline glucose and d) percentage body fat.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5452 0
New Zealand
State/province [1] 5452 0
Canterbury

Funding & Sponsors
Funding source category [1] 288063 0
Charities/Societies/Foundations
Name [1] 288063 0
Diabetes Christchurch
Address [1] 288063 0
550 Hagley Ave
Riccarton
Christchurch 8001
Country [1] 288063 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen Lunt
Address
Diabetes Centre, Canterbury District Health Board
550 Hagley Ave
Riccarton
Christchurch 8001
Country
New Zealand
Secondary sponsor category [1] 286832 0
University
Name [1] 286832 0
University of Otago Christchurch
Address [1] 286832 0
2 Riccarton Ave
Christchurch Central
Christchurch 8011
Country [1] 286832 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290034 0
Health and Disability Ethics Committee
Ethics committee address [1] 290034 0
Ministry of Health
No 1 The Terrace
Wellington Central
Wellington 6011
Ethics committee country [1] 290034 0
New Zealand
Date submitted for ethics approval [1] 290034 0
09/10/2013
Approval date [1] 290034 0
30/10/2013
Ethics approval number [1] 290034 0
13/STH/148

Summary
Brief summary
In healthy volunteers, tissue uptake of glucose after a meal results in a glucose gradient between the capillary blood at the finger and venous blood at the level of the antecubital fossa. We hypothesise that a similar [capillary-glucose] gradient exists in type 1 diabetes patients. If it does, this has implications for calibration of continuous glucose monitors. It also has implications when considering capillary and venous samples to be bio-equivalent when defining hypoglycaemic events, for example during pharmaceutical trials in participants with type 1 diabetes.
Trial website
Trial related presentations / publications
I. Lee, H. Lunt, H. Chan, H. Heenan, J. Berkeley, C. M. A. Frampton. Postprandial capillary–venous glucose gradient in Type 1 diabetes: magnitude and clinical associations in a real world setting. Diabet Med 2015.
DOI: 10.1111/dme.13025
Public notes

Contacts
Principal investigator
Name 43378 0
Dr Helen Lunt
Address 43378 0
Diabetes Centre
550 Hagley Ave
Riccarton
Christchurch 8001
Country 43378 0
New Zealand
Phone 43378 0
+64 3 3640860
Fax 43378 0
+64 3 3640171
Email 43378 0
helen.lunt@cdhb.health.nz
Contact person for public queries
Name 43379 0
Dr Helen Lunt
Address 43379 0
Diabetes Centre
550 Hagley Ave
Riccarton
Christchurch 8001
Country 43379 0
New Zealand
Phone 43379 0
+64 3 3640860
Fax 43379 0
+64 3 3640171
Email 43379 0
helen.lunt@cdhb.health.nz
Contact person for scientific queries
Name 43380 0
Dr Helen Lunt
Address 43380 0
Diabetes Centre
550 Hagley Ave
Riccarton
Christchurch 8001
Country 43380 0
New Zealand
Phone 43380 0
+64 3 3640860
Fax 43380 0
Email 43380 0
helen.lunt@cdhb.health.nz