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Trial registered on ANZCTR


Registration number
ACTRN12617001585314
Ethics application status
Approved
Date submitted
15/11/2017
Date registered
28/11/2017
Date last updated
12/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Patterns of glucose self-monitoring in type 1 diabetes
Scientific title
Relationship between patterns of glucose self-monitoring in type 1 diabetes and HbA1c (glycated haemoglobin): a feasibility study
Secondary ID [1] 293368 0
None
Universal Trial Number (UTN)
U1111-1205-1866
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 305491 0
Condition category
Condition code
Metabolic and Endocrine 304743 304743 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with type 1 diabetes will be asked to 'donate' their most recent glucose finger stick test results, including a time and date stamp for each glucose value, as stored in their glucose meter memory. This information would typically contain three months of retrospective information, collected by the patient. These glucose data will be linked to patient age, gender and their most recent HbA1c blood test. Patients will also be asked to complete a questionnaire about meal times and sleep times, so this lifestyle information can also be linked with their glucose finger stick data.
Intervention code [1] 299622 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303960 0
Relationship between finger stick testing frequency data obtained from glucose meter and HbA1c, obtained from most recent blood test.
Timepoint [1] 303960 0
As recorded at the time of study data collection
Secondary outcome [1] 340543 0
Glucose meter download results from participants with at least one week of consecutive meter download information available for analysis, will be categorized into one of three groups: i) results which show evidence of structured testing (i.e. a clear relationship exists between testing times and measured lifestyle factors such as mealtimes and sleep times), ii) results which show evidence semi-structured testing (as an example this might be regular testing on waking and/or at bedtime) and iii) results which show evidence of unstructured testing only (no apparent relationship between glucose testing and mealtimes or sleep patterns). Participant HbA1c from these three groups, will then be compared.
Timepoint [1] 340543 0
As recorded at the time of study data collection

Eligibility
Key inclusion criteria
Patients with type 1 diabetes who bring a functioning glucose meter with them, to their routine diabetes clinic visit.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who present to clinic with a faulty glucose meter, which has no accessible glucose values in its memory.
2. Patients who present to clinic either with no meter, or with a meter that does not have a memory.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
This is a semi-descriptive feasibility study and analyses will be exploratory.

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] 9361 0
New Zealand
State/province [1] 9361 0
Canterbury

Funding & Sponsors
Funding source category [1] 297992 0
Government body
Name [1] 297992 0
Canterbury District Health Board
Address [1] 297992 0
32 Oxford Terrace, Christchurch 8011
Country [1] 297992 0
New Zealand
Funding source category [2] 298044 0
University
Name [2] 298044 0
University of Canterbury
Address [2] 298044 0
20 Kirkwood Ave, Upper Riccarton, Christchurch 8041
Country [2] 298044 0
New Zealand
Primary sponsor type
Individual
Name
Helen Lunt
Address
Diabetes Centre
550 Hagley Ave
Christchurch 8011
Canterbury
Country
New Zealand
Secondary sponsor category [1] 297058 0
Individual
Name [1] 297058 0
Jennifer Brown
Address [1] 297058 0
School of Mathematics and Statistics
University of Canterbury
20 Kirkwood Ave
Upper Riccarton
Christchurch 8041
Country [1] 297058 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299031 0
Health and Disability Ethics Committee (Northern B)
Ethics committee address [1] 299031 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299031 0
New Zealand
Date submitted for ethics approval [1] 299031 0
31/10/2017
Approval date [1] 299031 0
14/11/2017
Ethics approval number [1] 299031 0
17/NTB/221

Summary
Brief summary
A standard part of diabetes self-care for patients with type 1 diabetes is undertaking regular glucose 'finger stick' testing. Ideally, testing is done in a structured way, in association with meal times. The glucose meters used for self testing in New Zealand 'remember' 1,000 tests. Structured, frequent glucose testing is often recommended, because it is associated with better overall glucose control, as measured by the HbA1c blood test. (In type 1 diabetes, the target HbA1c is above the physiologic range but high values are associated with an increased risk of diabetes complications).
Structured glucose testing is however very demanding of patients so is usually not sustainable, for more than a short period of time.

This study aims to describe patterns of glucose testing in patients with type 1 diabetes, by downloading their glucose meter results and comparing this with their most recent HbA1c result.
Trial website
Trial related presentations / publications
Public notes
In New Zealand, almost all patients have access to a (government) funded glucose memory meter. Our clinic's standard practice is to recommend that patients bring a memory meter with them, to all clinic visits.

Contacts
Principal investigator
Name 79050 0
A/Prof Helen Lunt
Address 79050 0
Diabetes Centre
550 Hagely Ave
Christchurch 8011
Country 79050 0
New Zealand
Phone 79050 0
+64 3 3640860
Fax 79050 0
+64 3 3640171
Email 79050 0
helen.lunt@cdhb.health.nz
Contact person for public queries
Name 79051 0
A/Prof Helen Lunt
Address 79051 0
Diabetes Centre
550 Hagely Ave
Christchurch 8011
Country 79051 0
New Zealand
Phone 79051 0
+64 3 3640860
Fax 79051 0
+64 3 3640171
Email 79051 0
helen.lunt@cdhb.health.nz
Contact person for scientific queries
Name 79052 0
A/Prof Helen Lunt
Address 79052 0
Diabetes Centre
550 Hagely Ave
Christchurch 801
Country 79052 0
New Zealand
Phone 79052 0
+64 3 3640860
Fax 79052 0
+64 3 3640171
Email 79052 0
helen.lunt@cdhb.health.nz

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary