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
Building 32,
Bruce Highway,
Rockhampton QLD 4701
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
In the study we trialled the effectiveness of a diabetes-related smart phone application to improve self-management and glycemic control in adult patients with T1DM. Specifically the aims of the project were to (i) trial the effectiveness of the ‘Glucose Buddy’ self-management application in improving glycemic control in adults with T1DM, (ii) trial the effectiveness of the ‘Glucose Buddy’ self-management application in producing relevant health behaviour change outcomes in adults with T1DM and, (iii) to examine the relationship of utilisation of the ‘Glucose Buddy’ application, patients engagement with the application and the level of self-care and glycemic control.
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.