Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000132842
Ethics application status
Approved
Date submitted
27/01/2012
Date registered
30/01/2012
Date last updated
30/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of the Diabetes Self-Management ‘Glucose Buddy’ Smartphone Application.
Scientific title
For an adult with Type 1 diabetes, does using a diabetes self-management smartphone application combined with text-message feedback improve glycemic control as compared to usual care.
Secondary ID [1] 279806 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 285678 0
Effect of a diabetes self-management smartphone application 285707 0
Condition category
Condition code
Metabolic and Endocrine 285875 285875 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Usual Care - 3-monthly visits to health care practitioner (general practitioner or endocrinologist) for 9-month duration of study. Plus Glucose Buddy iPhone App allows patients to enter in diabetes parameters (blood glucose, insulin, physical activity and diet). Text-message feedback from a Credentialed Diabetes Educator on a weekly basis for 6-months. Minimum of one text message a week, maximum of three. Feedback related to diabetes care - primarily stabilizing blood glucose levels.
Intervention code [1] 284122 0
Treatment: Other
Comparator / control treatment
Usual Care - 3-monthly visits to health care practitioner (general practitioner or endocrinologist) for 9-month duration of study.
Control group
Active

Outcomes
Primary outcome [1] 286372 0
The primary outcome measure is the improvement in glycemic control assessed by a patients glycosylated haemoglobin levels (HbA1c). HbA1c is regarded an optimal parameter for assessing long term quality of glycemic control (Biermann, et al., 2000). This measure is a reliable indicator of glucose control over the preceding 2-3 months (Australasian Paediatric Endocrine Group, 2005). This measure will be collected at each data collection point (baseline and 3-monthly) by a pathology lab as requested by the patients' General Practitioner (within the conventional care plan of patients with T1DM). The Bayer DCA 2000 + glycohaemoglobin analyser (Bayer Australia, Melbourne, Vic) is the standard instrument in Australia to analyse the HbA1c levels of patients.
Timepoint [1] 286372 0
Baseline, 3 months, 6 months, 9 months
Secondary outcome [1] 295704 0
Diabetes-related self-efficacy will be measured using the short form of the Diabetes Empowerment questionnaire (DES-SF). The DES-SF questionnaire measures eight conceptual dimensions i.e., assessing the need for change, developing a plan, overcoming barriers, asking for support, supporting oneself, coping with emotion, motivating oneself, and making diabetes care choices appropriate for one?s priorities and circumstances. Research has shown that DES-SF is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy (Anderson, et al., 2003; Anderson, et al., 2000).
Timepoint [1] 295704 0
Baseline, 3 months, 6 months, 9 months
Secondary outcome [2] 295705 0
The revised version of the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire will be used to assess diabetes self-management behaviours for diet, physical activity, blood glucose testing, foot checks, and smoking. The SDSCA is a brief, reliable, valid, and multidimensional measure of diabetes self-care behaviours based on self report. Psychometric analyses support the construct validity and internal consistency reliability of SDSCA in an adult diabetes population (Toobert, et al., 2000) .
Timepoint [2] 295705 0
Baseline, 3 months, 6 months, 9 months
Secondary outcome [3] 295706 0
Diabetes-specific quality of life will be measured using the Diabetes Quality of Life questionnaire (DQOL) developed specifically for insulin-dependent diabetes patients. The DQOL was initially designed for use in the DCCT (DCCT Research Group, 1996) and has demonstrated high degrees of internal consistency and test-retest reliability (Jacobson, Barofsky, Cleary, & Rand, 1988). The DQOL has 46 core items and four major dimensions: treatment satisfaction, treatment impact, worry about long-term complications, and worry about social/vocational issues. Patients respond to all items on a 5-point Likert scale. A score of 1 indicates no impact, no worries, or always satisfied. A score of 5 represents always affected, always worried, or never satisfied.
Timepoint [3] 295706 0
Baseline, 3 months, 6 months, 9 months
Secondary outcome [4] 295707 0
Smartphone Application Usage - as described by the number of logs (blood glucose, physical activity, diet, insulin) entered into the app by a participant.
Timepoint [4] 295707 0
6-month
Secondary outcome [5] 295708 0
Intervention engagement - as measured by the number of text-messages sent from Credentialed Diabetes Educator to patients and the number of text-messages sent from patients to Credentialed Diabetes Educator.
Timepoint [5] 295708 0
6-month

Eligibility
Key inclusion criteria
-Diagnosed with Type 1 Diabetes
-Duration of disease > 6 months
-Treated with multiple daily injections (MDI) or continuous subcutaneous insulin injections (Insulin Pump)
-Inadequate glycemic control (HbA1c > 8%)
-Own an iPhone and not currently using an iPhone application to self-monitor diabetes
-Consent from patient and patient’s general practitioner to participate
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Pregnant patients with Type 1 Diabetes
-Early indicators of diabetes related complications: retinopathy, neuropathy, nephropathy and heart-disease

General practitioner or endocrinologist of patient had to provide consent for their participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who volunteered to take part in study were contacted by the project staff to determine participant eligibility as per inclusion/exclusion criteria. Those who meet inclusion criteria were asked to provide ethical consent and have baseline measures taken. The primary outcome measure of glycemic control (HbA1c) was collected by a pathology laboratory, which the patient has been referred to by their general practitioner as per the norm of a diabetes care plan (usual care). The secondary outcome measures was collected via a web survey. Following baseline data collection participants were randomly allocated to one of the two arms of the research (control/intervention). Randomisation was undertaken by an independent researcher using a freely available online randomisation program (randomization.com). Individuals selected to the intervention arm were given information regarding the download and use of the Glucose Buddy application and website (http://www.beta.glucosebuddy.com).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation was undertaken by an independent researcher using a freely available online randomisation program (www.randomization.com).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284582 0
University
Name [1] 284582 0
Central Queensland University
Country [1] 284582 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Building 18,
Bruce Highway,
Rockhampton QLD 4701
Country
Australia
Secondary sponsor category [1] 283518 0
None
Name [1] 283518 0
Address [1] 283518 0
Country [1] 283518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286568 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 286568 0
Ethics committee country [1] 286568 0
Australia
Date submitted for ethics approval [1] 286568 0
Approval date [1] 286568 0
16/07/2010
Ethics approval number [1] 286568 0
H10/06-119

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33682 0
Address 33682 0
Country 33682 0
Phone 33682 0
Fax 33682 0
Email 33682 0
Contact person for public queries
Name 16929 0
Morwenna Kirwan
Address 16929 0
Building 18,
Bruce Highway
Central Qld University
Rockhampton QLD 4701
Country 16929 0
Australia
Phone 16929 0
+61749232546
Fax 16929 0
+61749306781
Email 16929 0
[email protected]
Contact person for scientific queries
Name 7857 0
Morwenna Kirwan
Address 7857 0
Building 18,
Bruce Highway
Central Qld University
Rockhampton QLD 4701
Country 7857 0
Australia
Phone 7857 0
+61749232546
Fax 7857 0
+61749306781
Email 7857 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.