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Trial registered on ANZCTR


Registration number
ACTRN12624001099516
Ethics application status
Approved
Date submitted
19/08/2024
Date registered
12/09/2024
Date last updated
12/09/2024
Date data sharing statement initially provided
12/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Disposable Sensor 5 (DS5) continuous glucose monitoring (CGM) device performance over a fifteen-day wear period
Scientific title
Evaluation of the Disposable Sensor 5 (DS5) continuous glucose monitor (CGM) performance and study feasibility over a fifteen-day wear period in young people with Type 1 diabetes
Secondary ID [1] 312762 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 334803 0
Condition category
Condition code
Metabolic and Endocrine 331361 331361 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-arm pilot study with both controlled (in-clinic hypo- and hyperglycaemic inductions) and free-living conditions, in 28 participants with Type 1 diabetes. Participants will wear between 2 to 4 blinded Disposable Sensor 5 (DS5) continuous glucose monitoring (CGM) devices on their upper arm over the course of 15 days. These sensors will not be replaced at any point during the 15-day period.
During this period, participants will undergo both a hypoglycaemia induction (by subcutaneous insulin bolus; target blood glucose level is 3.0 mmol/L) and a hyperglycaemia induction (by ingestion of a carbohydrate-rich meal with no insulin meal bolusing; target blood glucose level greater than or equal to 13.9 mmol/L). The carbohydrate-rich meal for the hyperglycaemia induction will depend on the participant's insulin-carb ratio, to be able to raise the person's blood glucose from euglycaermia to greater than or equal to 13.9 mmol/L, and will be determined by the study nurse on the day of induction. These inductions will occur on any combination of the following study days:
Day 1 (within 2 hours of sensor start)
Day 1 (between 2 and 24 hours of sensor start)
Day 2
Day 3
Day 4
Day 5
Day 8
Day 10 (post sensor start)

The sequence of the inductions will be determined by the arrival blood glucose level on first induction:
- <5.5 mmol/L will lead to a hypoglycaemic induction first OR
- Greater or equal to 11.1 mmol/L will lead to a hyperglycaemic induction first OR
- Greater or equal to 5.5 and <11.1 mmol/L, first induction will be assigned by the PI.
The second induction will depend on which induction (hypo/hyper) has been performed in the first in-clinic induction day above.

Allocation of the 28 participants to the 2 in-clinic days each, will result in four participants per induction per study day.

During the inductions, sensor performance will be compared with venous blood glucose measurements (participants will have a cannula inserted to continuously draw blood), determined using the Yellow Springs Instrument (YSI) glucose analyser, the gold standard for blood glucose measurements in clinical trials. On all other study days, participants will be advised to routinely perform at least 6 finger-prick tests of their blood glucose levels to enable evaluating differences in sensor glucose during these time periods.

Each participant will attend in-clinic between 3 and 4 times within the 15 days of study period, as follows:
Day 1 = eligibility check, consent, familiarisation, sensors insertion (2 hours)
Day 1 to Day 10: Randomised to first in-clinic induction day (6 hours)
Day 1 to Day 10: 2nd in-clinic induction day (6 hours)
Day 15 = sensor removal and study completion (1 hour)

The following will be collected to assess the feasibility of the study protocol: recruitment rate (number of patients recruited, number approached, time frame of recruitment), retention (proportion of recruited sample completing the study), device failure rate (percent of devices failing within 15 days), proportion of readings falling outside the reportable range.
Logs will be maintained outlining logistical difficulties encountered during the pilot phase and will be disseminated amongst the research group. Where possible, strategies to overcome/minimise the impact of these difficulties will be identified.
Intervention code [1] 329293 0
Treatment: Devices
Comparator / control treatment
During hypo- and hyperglycaemic inductions, sensor performance will be assessed against the gold standard venous glucose readings (participants will have a venous cannula inserted to continuously draw blood) generated by the bedside Yellow Springs Instrument (YSI) glucose lactate analyser. During all other study days ("at home"), participants will be encouraged to do at least 6 finger-prick blood glucose level measurements per day.
Control group
Active

Outcomes
Primary outcome [1] 339124 0
Feasibility of study protocol
Timepoint [1] 339124 0
End of the study period
Secondary outcome [1] 438638 0
Number and type of logistical difficulties, including study interventions, the wearing of the sensor, the time spent in the study per participant and the number of study visits.
Timepoint [1] 438638 0
During the pilot phase (at any point during the study) for a maximum of 3 weeks after the last participant enrolment.
Secondary outcome [2] 438640 0
Absolute Relative Difference between Yellow Springs Instrument (YSI) glucose measurement and sensor glucose value during a hypoglycaemic induction
Timepoint [2] 438640 0
During the hypoglycaemic induction in-clinic visit
Secondary outcome [3] 439087 0
Absolute Relative Difference between Yellow Springs Instrument (YSI) glucose measurement and sensor glucose value during a hyperglycaemic induction
Timepoint [3] 439087 0
During the hyperglycaemic induction in-clinic visit
Secondary outcome [4] 439237 0
Device removal acceptability
Timepoint [4] 439237 0
On Day 15 post sensor start, or at the time of sensor removal if earlier
Secondary outcome [5] 439238 0
Study protocol acceptability
Timepoint [5] 439238 0
During the pilot phase (at any point during the study) for a maximum of 3 weeks after the last participant enrolment

Eligibility
Key inclusion criteria
a) Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus, diagnosed at least 6 months ago)
b) Age 14 to 26 years
c) HbA1c <10% in the last 3 months preceding Day 1
d) Willing to follow study instructions
e) Willing to perform greater than or equal to 6 finger stick blood glucose measurements daily
f) Willing to attend all in-clinic days allocated
g) Capable of reading and understand instructions in English
h) Living in an area with internet and cellular phone coverage
Minimum age
14 Years
Maximum age
26 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Has a history of allergy to dexamethasone or has been told by health care provider they may not take any products containing dexamethasone.
b) Has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
c) Severe Diabetic Ketoacidosis (DKA) in the 6 months prior to Day 1
d) Has a history of a severe hypo (convulsions/coma) in the past 12 months
e) Has a history of a seizure disorder
f) Actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study drug or device in the last 2 weeks
g) Poor visual acuity precluding use of the investigational technology
h) Inability or unwillingness to meet protocol requirements
i) Severe or unstable medical or psychological condition which, in the opinion of the treating physician and/or investigator, would compromise the ability to meet protocol requirements e.g. participants with history of cardiovascular (angina, myocardial infarction) and cerebrovascular events (stroke).
j) Females who are pregnant.

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Participants will be randomised to numbers 1 through 28 to allocate them to the different combinations of in-clinic induction days.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
(1) The following will be presented for this pilot study
• Recruitment rate
• Patients recruited per week.
• Conversion rate
• Percentage of patients approached that enrolled into the study
• Retention rate
• Percentage of patients enrolled that completed the study
• Device failure
• Percentage of the total number of devices distributed that failed prior to 15 days
• Time to device failure (days)
• Sensor removal
• Percentage of the total number of sensors that were removed prior to 15 days
• Time to sensor removal
• Percentage of in clinic YSI readings falling outside the reportable range
• Reason for declining study
• Reason for withdrawing from study
• Source of failure
• Reason for removal


(2) The absolute relative difference will be calculated at each paired time point (tk) using the following formula for each set of paired observations:

ARD(k) = (|Ycgm(tk)-Yref(tk)|)/Yref(tk)

The following will be calculated over study day stratified by glycaemic condition (hypo-, or hyperglycaemia)based on all DS5-YSI paired observations falling within the reportable range (2.22 – 22.22 mmol/L):

• Mean/SD absolute relative difference (MARD) for each study day (day 1 to 15)
• Median/IQR ARD for each study day
• Mean absolute difference (MAD)
• Median/IQR absolute difference
• Aggregate MARD over all days
• Aggregate MAD over all days
• Sensor glucose plotted against reference glucose (fit to Clarke Error Grid)
• Proportion of sensor glucose observations falling within 20% of reference value
• Proportion of sensor glucose observations falling within 1.11 mmol/L of reference reading (for reference values < 4.44 mmol/L)

Similar will be produced for all paired DS5-Accu-Chek BGL observations.

To inform simulation-based power calculations, estimates of variability attributable to participant and device, and the residual variability, will be estimated using a linear mixed model of the log-transformation of ARD including random intercepts for individual and device, and including fixed effects terms for study day and glycaemic condition (hypo-, or hyperglycaemia). Residual autocorrelation will be explored. These outputs will be compared to those gathered from larger studies of older devices and will be used to inform simulation-based power calculations for the main study.

The final data set, per individual and per study day, will include:
a) 15 minutely finger prick and YSI readings (with 5 minutely readings for 2 hours when the glucose reading is below 4 mmol/L) per in-clinic study day
b) Five minutely sensor glucose readings over the 15-day sensor wear period
c) At least 6 finger-prick readings per day over the 15-day sensor wear period

For each individual wearing at least two sensors, this then equates to:
a) 32 YSI values (16 hypo induction and 16 hyper induction) during the two in-clinic study days
b) 8640 per sensor readings over the 15-day study period
c) 90 finger-prick values over the 15-day study period including two in-clinic days

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/10/2024
Actual
Date of last participant enrolment
Anticipated
15/09/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26953 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 43025 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 317195 0
Commercial sector/Industry
Name [1] 317195 0
Medtronic USA
Country [1] 317195 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
Country
Australia
Secondary sponsor category [1] 319463 0
None
Name [1] 319463 0
Address [1] 319463 0
Country [1] 319463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315935 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315935 0
https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
Ethics committee country [1] 315935 0
Australia
Date submitted for ethics approval [1] 315935 0
12/07/2024
Approval date [1] 315935 0
22/08/2024
Ethics approval number [1] 315935 0
RGS0000006703

Summary
Brief summary
This is a single-arm pilot study, involving 28 individuals with diabetes; aged between 14 and 26 years old, wearing up to four blinded DS5 sensors for a period of 15 days. The DS5 device is a new disposable sensor platform utilising the Enlite 3 sensor technology which provides a longer sensor wear and improved ease of device insertion. The product incorporates an insertion device, a sensor recorder, and sensor flex into a single disposable device.
The primary aims of this pilot study will be to assess the feasibility and acceptability of the study protocol, familiarise the team with the study procedures, identify potential logistical difficulties that may arise in the main study, and collect estimates of parameters to inform power calculations for the larger study.
Sensor performance will be assessed against the gold standard venous glucose readings generated by the bedside Yellow Springs Instrument (YSI) glucose lactate analyser. Patient visits will be scheduled to ensure observations are equally spread over 10 days for both the hypo- and hyper-glycaemic conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136270 0
Prof Timothy W Jones
Address 136270 0
Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 136270 0
Australia
Phone 136270 0
+61 8 6456 5033
Fax 136270 0
Email 136270 0
[email protected]
Contact person for public queries
Name 136271 0
Timothy W Jones
Address 136271 0
Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 136271 0
Australia
Phone 136271 0
+61 8 6456 5033
Fax 136271 0
Email 136271 0
[email protected]
Contact person for scientific queries
Name 136272 0
Timothy W Jones
Address 136272 0
Perth Children's Hospital, 15 Hospital Avenue, Nedlands WA 6009
Country 136272 0
Australia
Phone 136272 0
+61 8 6456 5033
Fax 136272 0
Email 136272 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


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.