Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000005853
Ethics application status
Approved
Date submitted
27/10/2020
Date registered
7/01/2021
Date last updated
7/01/2021
Date data sharing statement initially provided
7/01/2021
Date results information initially provided
7/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Daily feedback on diet and activity in patients with type 2 diabetes
Scientific title
Impact of an integrated glucose, food intake and activity tracker with physician-authored daily feedback on glycaemia, body composition and behaviour in subjects with type 2 diabetes
Secondary ID [1] 302633 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
GLOOK!
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 319532 0
Condition category
Condition code
Metabolic and Endocrine 317482 317482 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with type 2 diabetes wore a continuous glucose monitor and an Apple Watch for 12 days. Uploaded data (activity (steps), heart rate, blood glucose level) were integrated into an App (specifically designed for the study) which also enabled the recording of activity and food consumed. This was completed multiple time each day by the participants every time they exercised or ate. A physician (endocrinologist) provided text-based daily feedback to each individual, based upon their data from each day of the study. App analytics were accessed to assess compliance
Intervention code [1] 318925 0
Behaviour
Intervention code [2] 319172 0
Treatment: Other
Intervention code [3] 319173 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325517 0
Hba1c (serum immunoassay)
Timepoint [1] 325517 0
zero and 12 days (before and after 12 day intervention)
Secondary outcome [1] 388260 0
Fructosamine (serum immunoassay)
Timepoint [1] 388260 0
zero and 12 days (before and after 12 day intervention)
Secondary outcome [2] 388261 0
Average subcutaneous fluid glucose as assessed by CGM ( Guardian Connect)
Timepoint [2] 388261 0
Day 1-4 vrs Day 9-12
Secondary outcome [3] 388262 0
Weight by digital scales
Timepoint [3] 388262 0
zero and 12 days (before and after 12 day intervention)
Secondary outcome [4] 389339 0
Acceptability of the outcome by structured interview
Timepoint [4] 389339 0
Day 12
Secondary outcome [5] 389340 0
Vital signs (BP and pulse) by automated sphigmomanometer
Timepoint [5] 389340 0
baseline and day 12

Eligibility
Key inclusion criteria
Type 2 diabetes
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to use a smartphone

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Student's T-test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/03/2018
Date of last participant enrolment
Anticipated
Actual
14/06/2018
Date of last data collection
Anticipated
Actual
26/06/2018
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17901 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 31762 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 307064 0
University
Name [1] 307064 0
Monash Institute of Medical Engineering seeding grant
Country [1] 307064 0
Australia
Primary sponsor type
University
Name
Monash institute of medical engineering
Address
Monash university Clayton Campus,
200 Wellington Road
Clayton, Victoria, Australia 3800
Country
Australia
Secondary sponsor category [1] 307634 0
None
Name [1] 307634 0
Address [1] 307634 0
Country [1] 307634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307188 0
Eastern Health Ethics Committee
Ethics committee address [1] 307188 0
Level 4, 5 Arnold Street., Box Hill, Victoria 3128
Ethics committee country [1] 307188 0
Australia
Date submitted for ethics approval [1] 307188 0
01/09/2017
Approval date [1] 307188 0
23/10/2017
Ethics approval number [1] 307188 0
LR632017

Summary
Brief summary
In view of the expected epidemic of type 2 diabetes, there is an urgent need for large-scale interventions that can prevent the progression from pre-diabetes to diabetes through encouraging change in health-related behaviours. We have set out to test the acceptability of receiving daily physician’s feedback informed by wearable continuous monitoring of subjects’ activity, food choices and glucose profiles with the aim of encouraging healthier behaviours in subjects with diabetes.

Fifteen subjects with type 2 diabetes wore a continuous glucose monitor and an Apple Watch for 12 days. Uploaded data were integrated into an App which also enabled the recording of activity and food consumed. A physician provided text-based daily feedback to each individual, based upon their data from each day of the study. At the beginning and the end of the study,data was collected on health related-behaviour, such as eating and exercise, and diabetes control assess the acceptability of the intervention.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 106334 0
Prof Chris Gilfillan
Address 106334 0
Esatern Health
Level 2, 5 Arnold Street
Box Hill
Victoria 3128
Country 106334 0
Australia
Phone 106334 0
+61 412560235
Fax 106334 0
Email 106334 0
[email protected]
Contact person for public queries
Name 106335 0
Prof Chris Gilfillan
Address 106335 0
Eastern Health
Level 2, 5 Arnold Street
Box Hill
Victoria 3128
Country 106335 0
Australia
Phone 106335 0
+61 412560235
Fax 106335 0
Email 106335 0
[email protected]
Contact person for scientific queries
Name 106336 0
Prof Chris Gilfillan
Address 106336 0
Eastern Health
Level 2, 5 Arnold Street
Box Hill
Victoria 3128
Country 106336 0
Australia
Phone 106336 0
+61 412560235
Fax 106336 0
Email 106336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Primary data is available for all participants
When will data be available (start and end dates)?
from 27/10/2020 to 27/10/2027
Available to whom?
Anyone by written application
Available for what types of analyses?
Any
How or where can data be obtained?
By correspondence with principle investigator ([email protected])


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.