Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000785303
Ethics application status
Approved
Date submitted
9/05/2017
Date registered
29/05/2017
Date last updated
5/04/2023
Date data sharing statement initially provided
3/04/2023
Date results provided
3/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of continuous glucose monitoring (CGM) systems as a self-monitoring tool to optimise blood glucose control in individuals with type 2 diabetes (T2D) - Pilot
Scientific title
The role of continuous glucose monitoring as a self-monitoring behaviour change tool to enhance glycemic control in individuals with type 2 diabetes - Pilot Study
Secondary ID [1] 291899 0
Nil Known
Universal Trial Number (UTN)
U1111-1196-4069
Trial acronym
CGMCONTT2D
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 303194 0
Glycaemic Control 303195 0
Overweight/Obesity 303249 0
Condition category
Condition code
Metabolic and Endocrine 302634 302634 0 0
Diabetes
Diet and Nutrition 302635 302635 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot feasibility study, to determine the effectiveness of real-time continuous glucose monitoring (RT-CGMS) compared with standard care self-management blood glucose (SMBG) approach for improving glycaemic control, reducing cardiovascular disease risk markers and enhancing quality of life in response to the prescription of a lifestyle modification program in overweight and obese individuals with type 2 diabetes (T2D).
Both groups will also perform usual self-monitoring blood glucose readings before each meal and at bedtime as per standard practice with morning fasting recordings to be provided to the study dietitian and Endocrinologist for review and support.
At study commencement (Week 0), participants will be counselled by a research dietitian for 1 hrs and receive a prescriptive low carbohydrate (50g or 14% of total energy) higher protein (28% of total energy) higher fat (58% of total energy) dietary plan and supporting materials (Meal plans, recipes, food lists), individualised for energy level using the Schofields’ energy equation. To facilitate dietary adherence, the dietary prescription will be structured to include a specific daily eating plan with foods listed in a quantitative food record that participants will be required to complete as a measure of overall dietary adherence, whilst dietitian for the trial will be entering the food data into a food database to ensure macronutrient adherence.

At week 3, participants will be provided face to face education on how to adapt the diet and add food exchanges into their day whilst remaining compliant to the intervention. Participants will be counselled by an accredited practising dietitian for up to 45 minutes and will be provided comprehensive materials including dietary plans, recipes, shopping lists to assist them to make appropriate energy and food exchanges to maintain the prescribed energy level and macronutrient profile. Participants will also receive a home-based exercise plan incorporating moderate intensity aerobic (walking)/resistance exercises (Theraband), consistent with diabetes Australia exercise recommendations. Materials provided will be visual guides and instructions on specific exercises and how to complete the activity journal. Intensity recommended will be 60-70% of max heart rate. Exercise session will be of at 30 mins a session every day (210mins minimum target a week) as per the diabetes Australia recommendations.
The activity journal will be provided to participants who will be asked to document their exercise type and time, this will be provided to the identify adherence to physical activity.
Apart from the introductory counselling session, participants will receive no further formal counselling regarding the components of the diet or exercise, but will have a contact number for the clinical trial manager for any queries. Queries of a lifestyle or medical nature will be directed to the respective researchers for follow-up.
Participants will attend 3 weekly follow-up clinic visits to return and collect glucose sensors, to document any adverse events and to have any questions regarding sensor management answered. At these visits, participants will be required to return activity journals and food records for compliance assessment.
These visits will be face to face with the trial manager for 30 minutes and a trial manager or PhD student will also measure weight, body composition and blood pressure and review blood glucose data for assessment of medication change requirements. It is likely that participants may be taking hypoglycaemic, antihypertensive and lipid-lowering medications and changes to oral hypoglycaemic medication will be required. The participant’s health will be monitored and periodically assessed by project clinician (Prof. Thompson) who will conduct a medication review when necessary .

For the intervention group, the Real Time CGM sensor will be inserted by a nurse into the lower abdominal, subcutaneous tissue, instructions on insertion will be provided.
** CGM sensor wear will be monitored by the clinical research nurse and returning of used sensors will be taken as a measure of compliance. The real time CGM instructions for participants is an attachment to this ANZCTR Trial record.

Duration: 12-week randomized controlled study

Participant: 20 overweight/obese individuals (BMI:26-45 kg/m2, age:20-75 yrs) with T2D will be randomly allocated to undertake 1 of 2 interventions:

Group 1 (N=10) – Prescription of a low carbohydrate, high protein and unsaturated fat diet (LC diet) combined with the use of a real-time continuous glucose monitor (worn continuously for 12 weeks).

Group 2 (N=10) - Prescription of a LC diet combined with the use of a non-display, ‘masked’ continuous glucose monitor (worn continuously for 12 weeks).
Intervention code [1] 298018 0
Treatment: Devices
Intervention code [2] 298019 0
Lifestyle
Intervention code [3] 298020 0
Behaviour
Comparator / control treatment
Group 2 (N=10) - Will be provided a prescribed LC diet combined with a home exercise plan (as per intervention). The difference will be the use of a non-display, ‘masked’ continuous glucose monitor (worn continuously for 12 weeks). Inclusion of the use of this “masked” monitor will ensure high-level scientific rigour of the study design is maintained by achieving a comparable level of interaction to Group 1. Participants will also be required to continue with their standard SMBGL, fasting daily.
Control group
Active

Outcomes
Primary outcome [1] 302046 0
Glycated Haemaglobin (A1C%)
Timepoint [1] 302046 0
Fasted blood sampling (MBA 20, Insulin and Lipids) will be obtained from consenting participants 0700-1100 in the mornings of their baseline visit (Wk 0) final visit, week 12 after trial commencement measured at a certified clinical laboratory using standard assay kits.
Primary outcome [2] 302047 0
24hr Blood Glucose Profile measured by continuous blood glucose monitoring device - Medtronic Guardian Connect (Commercially Available in Australia)
Timepoint [2] 302047 0
Blood Glucose is obtained every 5 minutes over 7 day intervals for 12 weeks
Primary outcome [3] 302048 0
Diabetes-related medication changes assessed by the validated an anti-glycemic medication effect score (MES) based on Medication changes documented by medication type and dosage changes.
Timepoint [3] 302048 0
Weeks 0 and 12 after trial commencement
Secondary outcome [1] 334615 0
Body Composition using InBody 270 bioimpendance scales
Timepoint [1] 334615 0
Weeks 0, 3, 6, 9, 12 after trial commencement
Secondary outcome [2] 334616 0
Blood Pressure using an automated sphygmomanometer (SureSigns Vs3, Phillips Medical Systems, MA, USA).
Timepoint [2] 334616 0
Weeks 0 and 12 after trial commencement
Secondary outcome [3] 334617 0
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI);
Timepoint [3] 334617 0
Weeks 0 and 12 post trial commencement
Secondary outcome [4] 334618 0
Physical activity measured using 7-day accelerometery and the international physical activity questionnaire (Ipaq)
Timepoint [4] 334618 0
Weeks 0 and 12 post trial commencement
Secondary outcome [5] 334619 0
Food intake using a 3 day weighed food records and diet histories
Timepoint [5] 334619 0
Weeks 0, 3, 6, 9 and 12 post trial commencement
Secondary outcome [6] 335292 0
Food Craving Eating Style using the food Craving Inventory (FCI);
Timepoint [6] 335292 0
Weeks 0 and 12 post trial commencement
Secondary outcome [7] 335293 0
Stress Survey using Perceived Stress Scale (PSS);
Timepoint [7] 335293 0
Weeks 0 and 12 post study commencement
Secondary outcome [8] 335294 0
Mental wellbeing using a series of validated assessment questionnaires, including - Diabetes Distress - Problem Areas in Diabetes Questionnaire (PAID); Diabetes Quality of life questionnaire: Diabetes 39 – Quality of Life Questionnaire,
Timepoint [8] 335294 0
Weeks 0 and 12 post study commencement
Secondary outcome [9] 335295 0
Acceptance and Tolerance of CGM Wear and Lifestyle plan ( 5 Subjective likert questions)
Timepoint [9] 335295 0
Weeks 6 and 12 post trial commencement

Eligibility
Key inclusion criteria
Inclusion Criteria
*Adults aged 20-75yrs (Male and Female)
*BMI 26-45kg/m2
* Diagnosed with Type 2 Diabetes
*With a HbA1c between 5.9-6.9% and ARE taking oral medications or insulin
* With a HbA1c between 7-12% with or without medications
* Must be willing to comply with the study procedures
*Have signed informed consent
*Able to attend appointments and live within the Adelaide Metropolitan area
*If female, not pregnant or breast feeding
*No history of heart disease or other heart abnormalities
*Do not strictly control or restrict the food and drinks that you have daily (i.e. *restrained eater questionnaire score greater than 10)
*Being weight stable (+/- 3kg) in the past 3 months
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
*Type 1 Diabetes
*Taking short acting insulin (i.e. Actrapid) Fitted with any electronic medical device / implant i.e. pacemaker
* Abnormality of clinical significance on medical history (including; current cancer, chronic lung disease, Depression, significant hormone problems (other than stable treated thyroid disease), kidney, respiratory, brain or gastrointestinal disease including gastrointestinal disease which may affect study outcomes)
* Any identified abnormality of specific blood or urine tests such as for liver function tests ((including ALT, AST or GGT greater than or equal to 2.5X upper limit of normal), Protein in the urine or HIV infection
*HBA1c greater than 12%
*BMI less than 26kg/m2 or greater than 45kg/m2
*Taking glucocorticoids such as prednisone [oral/inhaled or topical] within last 3 months.
* Use of illicit drugs
*Psychotropics other than a stable dose of an antidepressant
*Musculoskeletal problems that prevent physical activity
*History of heavy alcohol consumption (more than 2 standard drink on > 4 days per week)
*History of or current eating disorder
*Not willing to cease alcohol consumption for study duration
*Not willing to comply with study protocols
*Inability to prepare meals or meet dietary requirements
*Extended absences due to travel or other commitments
*Active/Current Gastro-Intestinal Disorders
*Past history of gastrointestinal surgery which may affect study outcomes (ie stomach surgery due to cancer)
*Diagnosed food intolerances (i.e. lactose intolerance)
*Medications which affect bowel movement or hunger /appetite (e.g.metoclopramide, domperidone and cisapride, anticholinergic drugs (eg atropine), erythromycin)
*Unable to comprehend the requirements of the study

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed study is to be a feasibility pilot study. The benefits of a feasibility pilot study is that it is a small-scale investigation that is conducted prior to an adequately powered randomized control trial, that provides researchers an opportunity to identify important parameters that are needed to design the main study. The purpose of this feasibility pilot is to look at the standard deviation of the primary outcome measures to estimate adequate sample size, willingness of participants to actively wear a CGM device and sensor and the tolerance of wear in time and location of sensor and the usefulness and limitations of the secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/06/2017
Actual
12/06/2017
Date of last participant enrolment
Anticipated
19/06/2017
Actual
19/06/2017
Date of last data collection
Anticipated
29/09/2017
Actual
29/09/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 15948 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 296403 0
Charities/Societies/Foundations
Name [1] 296403 0
Diabetes Australia Research Trust (DART)
Country [1] 296403 0
Australia
Funding source category [2] 296581 0
Commercial sector/Industry
Name [2] 296581 0
Medtronic Australisia Pty.Ltd.
Country [2] 296581 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Gate 13, Kinotre Avenue Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 295344 0
Commercial sector/Industry
Name [1] 295344 0
Medtronic Australisia Pty.Ltd
Address [1] 295344 0
Medtronic Australasia Pty Ltd
5 Alma Road
Macquarie Park NSW 2113
PO Box 945
North Ryde NSW 1670
* provision of CGM Devices and Sensors
Country [1] 295344 0
Australia
Secondary sponsor category [2] 295346 0
University
Name [2] 295346 0
University of Adelaide
Address [2] 295346 0
North Tce,
City of Adelaide
SA 5000
Country [2] 295346 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297630 0
University Of Adelaide Human Research Ethics Committee
Ethics committee address [1] 297630 0
Ethics committee country [1] 297630 0
Australia
Date submitted for ethics approval [1] 297630 0
20/03/2016
Approval date [1] 297630 0
22/03/2017
Ethics approval number [1] 297630 0
H-2016-259
Ethics committee name [2] 297632 0
CSIRO Human Research Ethics Committee
Ethics committee address [2] 297632 0
Ethics committee country [2] 297632 0
Australia
Date submitted for ethics approval [2] 297632 0
23/03/2017
Approval date [2] 297632 0
24/03/2017
Ethics approval number [2] 297632 0
RR 4-2017

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1743 1743 0 0
/AnzctrAttachments/372898-CGM Insertion Instructions HREC 2017-259.pdf (Supplementary information)
Attachments [2] 1744 1744 0 0
/AnzctrAttachments/372898-RR 4_2017 endorsement 240317.pdf (Ethics approval)

Contacts
Principal investigator
Name 74650 0
A/Prof Grant Brinkworth
Address 74650 0
CSIRO Food and Health
Riverside Corporate Park
11 Julius Avenue, North Ryde NSW 2113.
Country 74650 0
Australia
Phone 74650 0
+61294905665
Fax 74650 0
Email 74650 0
[email protected]
Contact person for public queries
Name 74651 0
Pennie Taylor (PhD Candidate)
Address 74651 0
CSIRO Food and Health
PO Box 10041, Adelaide, South Australia, 5000
Country 74651 0
Australia
Phone 74651 0
+61 8 83038954
Fax 74651 0
Email 74651 0
[email protected]
Contact person for scientific queries
Name 74652 0
Campbell Thompson
Address 74652 0
University of Adelaide
Discipline of Medicine
North Terrace
Adelaide, South Australia 5000
Country 74652 0
Australia
Phone 74652 0
+61 8 83038954
Fax 74652 0
Email 74652 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Part of a PhD Thesis


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.