Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000635763
Ethics application status
Approved
Date submitted
12/12/2021
Date registered
29/04/2022
Date last updated
29/04/2022
Date data sharing statement initially provided
29/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A general practice delivered, technology supported, lifestyle program for Type 2 Diabetes (T2D) management – Evaluation Study (GP-T2D)
Scientific title
A general practice delivered, diabetes technology supported, lifestyle program for Type 2 Diabetes (T2D) management – an efficacy, feasibility and acceptability evaluation Study (GP-T2D)
Secondary ID [1] 306022 0
CSIRO OD 216804
Universal Trial Number (UTN)
U1111-1272-4879
Trial acronym
GP-T2D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 324655 0
Glycaemic Control 324656 0
Overweight/Obesity 324657 0
Condition category
Condition code
Diet and Nutrition 322107 322107 0 0
Obesity
Metabolic and Endocrine 322108 322108 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pragmatic, feasibility trial of . N = 40 participants recruited across 3 GP Clinics in SA and NSW.

At the baseline (wk 0) appointment, the treating GP will provide the participant with a product kit, provided free to the participant, consisting of the CSIRO Low Carb Diabetes Diet and Exercise Program (Commercial Book publication) combined with use of a commercially available real-time continuous blood glucose monitoring system (Medtronic, Guardian Connect system including disposable sensors, access to the guardian connect app, and quick start information guide). Education on the product kit and how to use will be delivered by the treating GP and supported by the quick start guides in the product kit in a 45-60 minute face to face session.

The product kit consists of the CSIRO Low Carb Diet commercial book (providing, of total energy 10-15% Carb; 40-45 % protein and 40-50% healthy fat(<10% SFA)) with a generalised Exercise Program of entry level strength training with a quick start information guide to inform participants to read specific starter details, i.e. pages 71-77, 82-83 and 276 including starting basic weight based or walking exercises of up to 150 mins a week). Exercises will be Low to Moderate in level, with the information being provided that Participants can be seen by Exercise physiologists as needed for personalisation or support for use of the exercise information.

The diet information provided in the product kit will be combined with use of a commercially available real-time continuous blood glucose monitoring system including disposable sensors and user guide (Including associated disposables such as finger sticks, glucometers and glucose testing strips).

Note: The quick start guides provide participants with clear and step by step instructions on how to implement the lifestyle pattern and CMG device usage. The quick start guides provide the public health reference, that if additional support is required, to make a booking with the GP to seek a referral to a health care professional for further information, to support individuals needs in obtaining compliance with the CSIRO low carb diet and lifestyle program.

The CGM quick start guide provides links to access videos of 5-30 mins in duration that provide education and support to the participant on, sensor insertion techniques, how to and need to change sensor every 10 days, guardian connect app user information for participants.

Throughout the intervention participants will have free access to a telephone hotline for personal technical support, without time limits in call access. For intervening lifestyle support visits with health care professionals, access to personal face to face or telehealth medical support is as per usual clinical care and participants can have access to allied health care services, with mandatory trial visits at Baseline education and week 12, each session delivered by the treating GP of 30-45 minutes of face to face time. Intervening weeks are as per clinician and patient agreement based on health care goal setting needs.

Intervention adherence will be captured using participant data collected by the GP, by the research office (CSIRO CI Taylor) observing visit attendance seeking 100% attendance (2 visits completed as the mandatory visits week 0 and 12) , compliance with device wear will be defined as at least 80% ( 68 of the total 84 days sensor wear required) and clinical improvements in glycaemic control, observed as a 0.5-1% reduction in A1c. Fidelity will also be assessed by obtaining data to analyse the type, frequency and mode of engagement between baseline and week 12 between the participant and GP and /or Allied Health practitioners. type of information provided will also be captured for a descriptive analysis.

End of Trial (Wk 12). Participants attends final visit with the GP, who will provide in addition to routine "usual care" support, personalised feedback on their device use and personal achievements, including but not limited to , weight change, glucose management and medication usage.

A post trial focus group, at the final visit, participants and treating GPs and practice managers will be invited by the CSIRO research team (CI Taylor) to participate, with no obligation, in a focus group to understand the efficacy, feasibility and acceptability of the health care model being tested. Two focus groups will be conducted by PI Taylor and
the research assistant over a one-hour period. Participants will be asked to respond to questions, only if they feel comfortable to do so.

These focus groups will be delivered as:

o Group 1: Health care providers delivering the product intervention
o Group 2: Participants using the product intervention

Focus group questions will consist of semi-structure questions, generally starting with an opening question and several follow up and prompting questions i.e.

Topic: Program Delivery
o Opening Question: when you first product, can you tell me about how you expected it to be delivered (to or by) you?
o Follow-up Question: How did you measure whether the product was being delivered in a successful or effective way for (you or your clinic)?
o Probing Question/s: How could this product be delivered better to access more individuals) living with Type 2 Diabetes? Tell us what you found most useful about the product?
Intervention code [1] 322422 0
Treatment: Devices
Intervention code [2] 322423 0
Lifestyle
Intervention code [3] 322424 0
Behaviour
Comparator / control treatment
No comparator/control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329869 0
Glycated Haemaglobin (A1c%)
Timepoint [1] 329869 0
Fasted blood sampling (MBA 20, Insulin, Lipids) will be obtained from consenting participants no longer than 3 months and up to 24hrs prior to their baseline (Wk 0) visit and at week wk 12 (Final visit).

These will be measured at a certified clinical laboratory using standard assays.
Primary outcome [2] 329870 0
24hr Blood Glucose Profile Measures, as measured by continuous blood glucose monitoring devices. (Medtronic Guardian Connect, commercially available in Aus.)
Timepoint [2] 329870 0
Blood glucose is obtained every 5 minutes over 7 day intervals for the entire 12 weeks.
Primary outcome [3] 329871 0
Information for diabetes medication type, dose and changes over time will be provided by GPs, from their medical records, From this data, Diabetes related medication changes will be assessed by the validated antiglycemic medication effect score (MES) using the medication changes as provided by clinical case note data, documented by medication type and dose adjustments over the 12 weeks.
Timepoint [3] 329871 0
Mandatory clinical visits for participants are baseline (week 0) and end of trial (week 12), where information will be collected on medication changes and usage during these visits.
Secondary outcome [1] 404110 0
Blood Pressure using clinically validated and practical tools avilable in GP clinics (Automated Sphygmomanometer)
Timepoint [1] 404110 0
Blood pressure will be obtained at the mandatory clinical visits for participants, baseline (week 0) and end of trial (week 12).
Secondary outcome [2] 404111 0
Specifically designed for the trial, The CSIRO CGM Device Acceptance and Tolerance Questionnaire will be delivered online to measure perceptions and experiences with regards to the CGM devices application, wear time and overall experience whilst using the device in combination with lifestyle materials and GP support. Although not validated, the questionnaire was previously used and published in :

Taylor PJ, Thompson CH, Luscombe-Marsh ND, Wycherley TP, Wittert G, Brinkworth GD, Zajac I. Tolerability and acceptability of real-time continuous glucose monitoring and its impact on diabetes management behaviours in individuals with Type 2 Diabetes - A pilot study. Diabetes Res Clin Pract. Sep 2019;155:107814
Timepoint [2] 404111 0
The acceptance and tolerance of CGM wear time questionnaire will be delivered to participants online via redcap, at week 6 and week 12 (final visit) for completion within 1 week of receiving the questionnaire.
Secondary outcome [3] 404112 0
up to 10 clinic participants (GPs, Nurses and Allied health) will be invited to participate in a 60 minute focus group, using semi-structured face to face or virtual group interviews to explore their experience in delivering or supporting the program during the past 12 weeks, Voice recordings will be conducted and participants de-identified. Attendance is optional.
Timepoint [3] 404112 0
Focus groups will be conducted within 2 weeks of the end of the trial (week 13 or week 14).
Secondary outcome [4] 404113 0
up to 6 participants (those who have completed the intervention) will be invited to participate in a 60 minute focus group, using semi-structured face to face or virtual group interviews to explore their experience in participating the program during the past 12 weeks,
Voice recordings will be conducted and participants de-identified. Attendance is optional.
Timepoint [4] 404113 0
Focus groups will be conducted within 2 weeks of the end of the trial (week 13 or week 14).

Eligibility
Key inclusion criteria
•18 to 75 years of age,
• BMI of > 27kg/m2
• identified as suitable as per clinical management needs, by their treating GP
• medically diagnosed as having type 2 diabetes
• willing to participate and engage with the lifestyle strategy prescribed
• able to read, speak and understand written English (resources will be presented in English
only)
• willing to wear and self-manage a real-time continuous glucose monitoring device and
sensor, including sensor insertion and removal
• willing to be monitored by the clinical research team
• Access to a smart phone
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have pre-existing Oncological issues
• HbA1 >15%
• diagnosed as having type 1 Diabetes
• pregnant or lactating women
• currently undergoing bariatric surgery or within the first 2 years of a bariatric surgery procedure
. Not willing to wear the CGM device
. Not willing to attend GP clinic for clinical appointments

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)
Not Applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a pragmatic trial that looks to explore the practical implications of delivering a T2D researched ,treatment protocol in clinical practice. Hence the non-randomised, non masked pragmatic approach to address feasibility, efficacy and acceptability of the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

The proposed study is a pragmatic pilot trial, designed to test real-world effectiveness of a research intervention. The benefits of this type of trial it is a small-scale investigation that is conducted prior to an adequately powdered randomised control trial, thus allowing the researchers to adequately identify parameters and refine protocols to suitably design a larger trial. Therefore, the statistical methods adopted for this pilot is to look at the standard deviation of the primary outcomes obtained at baseline (week 0) and end of trial (week 12) to measure an appropriate sample size, and to develop a thematic understanding of the acceptability, feasibility and efficacy of the intervention delivery by the Clinicians and engagement with participants, including thematic evaluation of the barriers and implications of CGM devices use in clinical practice.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2022
Actual
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
16/09/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 36194 0
2565 - Ingleburn
Recruitment postcode(s) [2] 36195 0
2154 - Castle Hill
Recruitment postcode(s) [3] 36196 0
5108 - Paralowie

Funding & Sponsors
Funding source category [1] 310363 0
Commercial sector/Industry
Name [1] 310363 0
Medtronic Australasia Pty Ltd
Country [1] 310363 0
Australia
Funding source category [2] 310364 0
University
Name [2] 310364 0
University of Adelaide
Country [2] 310364 0
Australia
Funding source category [3] 310365 0
University
Name [3] 310365 0
The university of South Australia
Country [3] 310365 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Address
Gate 13, Kintore Avenue
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 311499 0
None
Name [1] 311499 0
Address [1] 311499 0
Country [1] 311499 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310018 0
CSIRO Health and Medical Research Ethics Committee
Ethics committee address [1] 310018 0
Ethics committee country [1] 310018 0
Australia
Date submitted for ethics approval [1] 310018 0
01/09/2020
Approval date [1] 310018 0
07/10/2020
Ethics approval number [1] 310018 0
2020-059 HREC

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

Contacts
Principal investigator
Name 116198 0
Dr Pennie Taylor
Address 116198 0
CSIRO
Gate 13,
Kintore Avenue
Adelaide, SA
5000
Country 116198 0
Australia
Phone 116198 0
+61 8 83038954
Fax 116198 0
Email 116198 0
Pennie.taylor@csiro.au
Contact person for public queries
Name 116199 0
Pennie Taylor
Address 116199 0
CSIRO
Gate 13,
Kintore Avenue
Adelaide, SA
5000
Country 116199 0
Australia
Phone 116199 0
+61 8 83038954
Fax 116199 0
Email 116199 0
Pennie.Taylor@csiro.au
Contact person for scientific queries
Name 116200 0
Pennie Taylor
Address 116200 0
CSIRO
Gate 13,
Kintore Avenue
Adelaide, SA
5000
Country 116200 0
Australia
Phone 116200 0
+61 8 83038954
Fax 116200 0
Email 116200 0
Pennie.Taylor@csiro.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Clinical practice confidentiality desired by collaborators


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
SourceTitleYear of PublicationDOI
EmbaseA primary care delivered, technology supported lifestyle program for Type 2 Diabetes Management: An evaluation of changes in metabolic health, feasibility, and acceptability - A pilot interventional study protocol.2023https://dx.doi.org/10.1016/j.conctc.2023.101152
N.B. These documents automatically identified may not have been verified by the study sponsor.