Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000224527
Ethics application status
Approved
Date submitted
17/02/2015
Date registered
9/03/2015
Date last updated
29/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Motivational Electronic Intervention Study for Patients Diagnosed with Type 2 Diabetes Mellitus
Scientific title
The effect of a Motivational Electronic Intervention Study for Patients Diagnosed with Type 2 Diabetes Mellitus (T2DM) (not currently on prescribed insulin) to determine whether blood HbA1c levels can be successfully and significantly reduced through exercise and healthy eating over a 26-week period.
Secondary ID [1] 286191 0
none
Universal Trial Number (UTN)
Trial acronym
The MEDS Clinical Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus (T2DM) 294220 0
Condition category
Condition code
Metabolic and Endocrine 294541 294541 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this clinical trial relates to electronic/ internet aids (mobile phone text messaging, emails, website usage and the constant wearing of a fitness tracker wristband) that will prompt patients diagnosed with T2DM to provide timely information of their lifestyle changes as part of the clinical study assessment requisite for this trial. The duration of this study is 26 weeks. Text messages and emails will be sent to participants daily. Participants are asked to use the website at least once per day to log their food. Lifestyle changes from prospective participants in this clinical trial will be captured throughout the study, through a food log submitted though the website portal and exercise data collected through a fitness tracker wristband worn by participants constantly throughout the study. Participants will utilise the website daily to log food. The electronic intervention can be used by clinicians to tailor personalised health goals for patients diagnosed with T2DM. The electronic intervention is aimed at motivating, promoting and guiding the participant to execute a modest exercise and activity regime and dietary plan to reduce blood HbA1c levels. The Personalised e Health website contains diabetic friendly recipes, physical activity research and exercise tips, motivational quotes and facts on T2DM. Participants will be financially reimbursed (at beginning and end of trial) for their time to attend the screening visit and information visit at the clinic. The second payment at the end of the trail acts as an incentive to follow and complete the full trial. Participants also get to keep the fitness tracker wristband after the completion of the trial. If participants abandon the trial, the wristband will be taken back and financial travel reimbursement will discontinue. Stool samples will also be required on two occasions (baseline and 26 weeks), which will be collected by the participant in their own home and used to assess faecal microbial profiles. Participants will be provided with a specialised kit to collect the stool samples, which will be couriered to Bioscreen in Melbourne, at no cost for the participant.
Intervention code [1] 291205 0
Lifestyle
Intervention code [2] 291330 0
Behaviour
Intervention code [3] 291331 0
Treatment: Other
Comparator / control treatment
Baseline vs 26 weeks of intervention
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294320 0
HbA1c changes over duration of the study. This will be assessed by Pathology testing- a 10 mL whole blood (EDTA or heparinized) sample will be collected from participants for HbA1c analyte.
Timepoint [1] 294320 0
26 weeks
Secondary outcome [1] 313033 0
Changes in participants weight over 26 week period, measured via scales.
Timepoint [1] 313033 0
26 weeks
Secondary outcome [2] 313174 0
Changes in blood pressure measured by blood pressure monitor
Timepoint [2] 313174 0
26 week study duration
Secondary outcome [3] 313175 0
Changes in waist circumference with tape measure
Timepoint [3] 313175 0
26 week study duration
Secondary outcome [4] 313361 0
Stool samples will be required on two occasions, which will be collected by the participant in their own home and used to assess faecal microbial profiles.
Timepoint [4] 313361 0
Baseline and 26 weeks

Eligibility
Key inclusion criteria
1) Participants between 18 years and 75 years old
2) Ownership and ability to operate a smart phone and personal computer
3) Willingness to wear a fitness tracker wristband day and night (24 hours)
throughout the entire study
4) Non-insulin-dependent type T2DM of more than 1 year’s duration
5) HbA1c no greater than 9.0% (75 mmol/mol) measured at the time of recruitment to the study
6) No chronic disease apart from (minor) complications of T2DM
7) Cognitive ability to give informed consent to participate
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) History of alcohol or substance abuse including use of illicit drugs
2) Female participants who are lactating or pregnant
3) Presence of significant diagnosed disease unrelated to T2DM
4) Presence of diagnosed psychiatric disease which would impair participation or where participation could adversely the subject
5) Any other clinically relevant condition or abnormality, which, in the judgment of the clinical investigator, would make the subject unsuitable for the trial (e.g., dietary allergies, psychiatric symptoms, visual impairment etc.)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n-of-1 intervention trial with no control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There was no statistical power and sample analysis carried out as there are no published studies on the use of electronic interventions to improve blood glucose management in type 2 diabetics. As such, the current study was designed as a pilot probing study. Furthermore, the data obtained from this study will allow for a more robust future study to be carried out.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9242 0
2015 - Alexandria

Funding & Sponsors
Funding source category [1] 290764 0
Commercial sector/Industry
Name [1] 290764 0
Personalised e-Health Clinic
Country [1] 290764 0
Australia
Primary sponsor type
Other
Name
Personalised e-Health Clinic
Address
66 McCauley St, Alexandria, NSW 2015.
Country
Australia
Secondary sponsor category [1] 289450 0
None
Name [1] 289450 0
None
Address [1] 289450 0
Country [1] 289450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292395 0
National Institute of Integrative Medicine
Ethics committee address [1] 292395 0
21 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 292395 0
Australia
Date submitted for ethics approval [1] 292395 0
Approval date [1] 292395 0
05/02/2015
Ethics approval number [1] 292395 0

Summary
Brief summary
A preliminary trial to assess the effectiveness of lifestyle and dietary intervention for the management of T2DM using electronic reminders, a fitness tracker wristband collecting exercise data and a web-based questionnaire to encourage participation. The question to be answered is whether the provision of quality dietary and exercise information known to be of benefit in T2DM control is better adopted by diabetics using simple electronic reminders and easy access to that information. There will be no control group, and this is an "n-of-one" trial in which each participant acts as their own control the beginning of the study. The degree of the participation will be matched to the outcome measures (HbA1c) to determine effectiveness of the entire approach. There is potential for follow-up of willing participants at 12 months.

The hypothesis investigated for this clinical trial proposes to demonstrate that blood HbA1c levels can be successfully and significantly reduced through a healthy eating / exercise programme that is implemented at baseline to 25 weeks participation. Blood levels of HbA1c is an objective and accurate marker of metabolic syndrome status and T2DM progression. A 13.5 % (from at least e.g., 55.5 mmol/mol to 48 mmol/mol) reduction in blood HbA1C level will be associated with significant improved health outcomes from baseline. This benefit may translate into a significant reduction in health care costs associated with T2DM. The electronic intervention serves as a motivating tool and guide that supports patient programme compliance, resulting in fewer doctor and other allied health affiliated practitioner visits and most importantly decreased T2DM disease progression.
Trial website
www.personalisedehealth.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55006 0
Dr Mark Donohoe
Address 55006 0
Cremorne Medical Practice
1 Guthrie Ave, Cremorne, NSW, 2090


Country 55006 0
Australia
Phone 55006 0
+ 61 (0)2 8969 6600
Fax 55006 0
+ 61 (0)2 8569 0185
Email 55006 0
[email protected]
Contact person for public queries
Name 55007 0
Ms Tessa Nikov
Address 55007 0
Medlab Clinical
66 McCauley St Alexandria NSW 2015
Country 55007 0
Australia
Phone 55007 0
(02) 8188 0311
Fax 55007 0
Email 55007 0
[email protected]
Contact person for scientific queries
Name 55008 0
Mr Luis Vitetta
Address 55008 0
Medlab Clinical
66 McCauley St Alexandria NSW 2015
Country 55008 0
Australia
Phone 55008 0
+61281880311
Fax 55008 0
Email 55008 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

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