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Trial registered on ANZCTR


Registration number
ACTRN12616000463471
Ethics application status
Approved
Date submitted
15/03/2016
Date registered
8/04/2016
Date last updated
6/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Real Time Continuous Glucose Monitoring and Everyday Diabetes Care
Scientific title
Real Time Continuous Glucose Monitoring and Psychosocial Outcomes in Type 1 Diabetes Management in Children and their Caregivers
Secondary ID [1] 288530 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes mellitus 297626 0
Condition category
Condition code
Metabolic and Endocrine 297811 297811 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Real time continuous glucose monitoring (RT CGM) provides an estimate of blood glucose levels every 5 minutes. This value is sent to the receiver and/or a smart phone and displays glucose values continuously. The system used in this study has an added feature which allows transmission of the glucose values via Bluetooth to a mobile device.
In this study we investigate the effect of the RT CGM with the ability to remotely monitor blood sugar levels on the everyday management of the diabetes of the participants and his caregiver/family. The study will follow a randomised crossover design, all participants will complete both arms, intervention and control. There is no washout period.

Intervention: Participants and their caregivers will use the RT CGM system in addition to their standard of care insulin therapy in a free living setting. They will be instructed on how to use continuous glucose monitoring including sensor insertion every week and sensor care; according to the user manual. A copy of the user manual will be given to them to take home. They will be instructed to keep a record of moderate and severe hypoglycaemia and use the same glucometer throughout the study period. The study doctor/study nurse will be in contact with participants to ensure the need for any additional support and troubleshooting.

Sensor data are stored on the transmitter/receiver. During the intervention arm, participants and their caregivers are asked to upload their sensor data to the computer fortnightly. After uploading, the data are accessible for the study team and if gaps are identified participants will be contacted to identify potential problems. Participant compliance and standard therapy will be monitored in their usual diabetes outpatient clinic.

Timeline: Participants and their caregivers will visit the research facility four times over a period of 7 months. Following baseline assessments where participants and their parents are asked to complete questionnaires regarding psychosocial factors and quality of life, they will start a 2 week run-in period to familiarise themselves with the RT CGM system. After the run-in period, they will be randomised to either the intervention or control arm for 3 months or vice versa. At the end of the 3 months participants will immediately cross over to the other arm. After completing each arm participants and their parents will be asked to complete questionnaires regarding psychosocial factors and quality of life again.
Intervention code [1] 293902 0
Treatment: Devices
Comparator / control treatment
Participants will be instructed to follow their NORMAL diabetes management with standard of care insulin therapy.
Control group
Active

Outcomes
Primary outcome [1] 297336 0
Fear of hypoglycaemia in parents of children with type 1 diabetes

This will be assessed using the Hypoglycaemia Fear Survey, parent version (University of Viginia)
Timepoint [1] 297336 0
This will be assessed at baseline and after the intervention and control period.
Primary outcome [2] 297846 0
Fear of hypoglycaemia in children with type 1 diabetes

This will be assessed using the Hypoglycaemia Fear Survey, child version (University of Viginia)
Timepoint [2] 297846 0
This will be assessed at baseline and after the intervention and control period.
Secondary outcome [1] 320759 0
Quality of life measures in parents of children with type 1 diabetes.

This will be assessed using the PedsQL Questionnaire (Family Module).
Timepoint [1] 320759 0
This will be assessed at baseline and after the intervention and control period.
Secondary outcome [2] 322415 0
Quality of life measures in children with type 1 diabetes.

This will be assessed using the PedsQL Questionnaire (General and Diabetes Module) and EQ-5D-Y (Participant and Proxy) questionnaire.

Timepoint [2] 322415 0
This will be assessed at baseline and after the intervention and control period.
Secondary outcome [3] 322416 0
Sleep quality in parents of children with type 1 diabetes.

This will be assessed using the Pittsburgh Sleep Quality Index.
Timepoint [3] 322416 0
This will be assessed at baseline and after the intervention and control period.
Secondary outcome [4] 322417 0
Anxiety in parents of children with type 1 diabetes.

This will be assessed using the State-Trait Anxiety Questionnaire (STAI) questionnaire.
Timepoint [4] 322417 0
This will be assessed at baseline and after the intervention and control period.
Secondary outcome [5] 322418 0
Depression, Anxiety and Stress in parents of children with type 1 diabetes.

This will be assessed using the Depression Anxiety Stress Scale (DASS).
Timepoint [5] 322418 0
This will be assessed at baseline and after the intervention and control period.
Secondary outcome [6] 322419 0
Glycaemic control

This will be assessed measuring HbA1c.
Timepoint [6] 322419 0
This will be assessed at baseline and after the intervention and control period.
Secondary outcome [7] 322562 0
Number of moderate and severe hypoglycaemic events.

This will be assessed using self reported episodes in the participant diary.
Timepoint [7] 322562 0
This will be assessed at baseline and after the intervention and control period.
Secondary outcome [8] 322677 0
Frequency of self monitoring blood glucose.

This will be assessed by downloading the glucosemeter, participants and their parents are asked to use only one glucose meter during the study period.
Timepoint [8] 322677 0
This will be assessed at baseline and after the intervention and control period.

Eligibility
Key inclusion criteria
a) Children aged 2-12 years old with type 1 diabetes mellitus on BD/MDI /CSII
b) Diabetes duration > 12 months
c) No CGM use in the preceding 6 months
d) Understands study protocol requirements and agrees to comply with the protocol
Minimum age
2 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Medical conditions (e.g. severe skin irritation problems) which precludes the use of CGM use
b) Any additional condition(s) that in the investigator’s opinion would warrant exclusion from the study or prevent the subject from completing 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)
Allocation is concealed through randomisation using a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will complete both conditions (intervention and control) following a crossover study design and the order of these conditions will be randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5268 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 12731 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 293127 0
Hospital
Name [1] 293127 0
Princess Margaret Hospital
Address [1] 293127 0
Princess Margaret Hospital for Children
Department of Diabetes and Endocrinology
99 Roberts Road
Subiaco WA 6008
Australia
Country [1] 293127 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Princess Margaret Hospital for Children
99 Roberts Road
Subiaco WA 6008
Australia
Country
Australia
Secondary sponsor category [1] 291924 0
None
Name [1] 291924 0
Address [1] 291924 0
Country [1] 291924 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294381 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 294381 0
Princess Margaret Hospital
99 Roberts Road
Subiaco WA 6008
Australia
Ethics committee country [1] 294381 0
Australia
Date submitted for ethics approval [1] 294381 0
08/12/2015
Approval date [1] 294381 0
15/03/2016
Ethics approval number [1] 294381 0
2016009EP

Summary
Brief summary
Despite rapid advances in the field of technology to monitor blood glucose continuously and prevent hypoglycaemia in type 1 diabetes (T1DM), the majority of patients, particularly young children, fail to achieve recommended HbA1C target of 7.5%. Real-time continuous glucose monitoring (RT CGM) offers the opportunity to improve diabetes control by providing a continuous glucose reading every 5 minutes. The most recent generation of RT CGM systems are more accurate in the hypoglycaemic range and have an added feature which allows transmission of the glucose values via bluetooth to a mobile device and share it with caregivers or health care providers. Little is known of the psychosocial impact of these technological advances on the patients and their caregivers.
This study aims to evaluate the impact of RT CGM with the added feature of remote monitoring on psychosocial factors such as fear of hypoglycaemia and quality of life measures in young children with type 1 diabetes mellitus (T1DM) and their parents.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63510 0
Dr Marie-Anne Burckhardt
Address 63510 0
Department of Endocrinology and Diabetes
Princess Margaret Hospital
99 Roberts Road
Subiaco WA 6008
Australia
Country 63510 0
Australia
Phone 63510 0
+618 9340 8090
Fax 63510 0
Email 63510 0
marie-anne.burckhardt@health.wa.gov.au
Contact person for public queries
Name 63511 0
Dr Marie-Anne Burckhardt
Address 63511 0
Department of Endocrinology and Diabetes
Princess Margaret Hospital
99 Roberts Road
Subiaco WA 6008
Australia
Country 63511 0
Australia
Phone 63511 0
+618 9340 8090
Fax 63511 0
Email 63511 0
marie-anne.burckhardt@health.wa.gov.au
Contact person for scientific queries
Name 63512 0
Dr Marie-Anne Burckhardt
Address 63512 0
Department of Endocrinology and Diabetes
Princess Margaret Hospital
99 Roberts Road
Subiaco WA 6008
Australia
Country 63512 0
Australia
Phone 63512 0
+618 9340 8090
Fax 63512 0
Email 63512 0
marie-anne.burckhardt@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary