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Trial registered on ANZCTR


Registration number
ACTRN12624000735550p
Ethics application status
Submitted, not yet approved
Date submitted
29/05/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Novel Continuous Glucose Monitoring System in Children and Adults with Type 1 and Type 2 Diabetes
Scientific title
A Prospective, Single-arm, Open-label, Interventional, Pilot Study to Evaluate the Efficacy and Safety of a Novel Continuous Glucose Monitoring System in Children and Adult Participants with Type 1 and Type 2 Diabetes
Secondary ID [1] 312235 0
None
Universal Trial Number (UTN)
U1111-1304-8396
Trial acronym
Linked study record
This study is a follow-up study to ACTRN12621000836831 and ACTRN12622000290796.

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 333937 0
Type 2 diabetes 333938 0
Condition category
Condition code
Metabolic and Endocrine 330609 330609 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, single arm, open label study to evaluate efficacy and safety of a novel continuous glucose monitoring (CGM) device by evaluating the glucose measured in comparison with an already commercially available CGM system (referred to as cCGM) and the reference standard which is capillary blood glucose in children and adult patients with type 1 and type 2 diabetes. The study will enrol 50 children and adolescents (7-17 years of age) and 50 adults (18 years and over). Parents/guardians of minors (under 16 years of age) will be involved in this study to support their children during the study visits, including device training, and with BG monitoring and record-keeping at home.
The novel CGM system consists of an interstitial glucose sensor worn in the upper arm continuously for up to 21 days, and which continuously transmits glucose data to a hand-held receiver to display sensor glucose readings, including current glucose value and a predicted glucose trend. Participants will not use the investigational novel CGM device (from here onwards referred to as nCGM) to make clinical or treatment decisions.
Both cCGM and nCGM consist of (1) a sensor worn on the upper arm that measures the glucose concentration in the interstitial fluid, (2) an integrated transmitter that send the results wirelessly and (3) a handheld receiver (e.g. mobile phone), that receives and displays the glucose data. While cCGM can be worn for up to 10 days, nCGM can be worn for up to 21 days. Both systems are calibration-free, and blood glucose calibrations can be performed at will by participants.
Participants are involved in the study for up to 51 days from screening to the final follow-up. Wear time of CGM devices is 23 days for participants. Participants will wear nCGM for 21 days to monitor the glucose values while maintaining their usual treatment method. All procedures at the clinic will be performed by trained members of the study team.
On day 1 of the study, participants will receive training on the use of the cCGM device and have a cCGM inserted in the back of one upper arm, then return home. This visit will take approximately 1 hour. On study day 2, participants will receive training on the use of the nCGM system and have 3 nCGM devices inserted in the back of the upper arms (in total 2 CGM devices worn on each upper arm). Participants will also receive training on the self-monitoring of blood glucose device CareSens Dual (hereinafter referred to as SMBG) for measuring of capillary blood glucose, and will be instructed to keep a daily blood glucose log. Following start-up of the nCGM devices, which takes approximately 30 minutes, capillary blood glucose testing will be performed every 10 minutes over a period of 2 hours. This visit will take approximately 3 hours. On days 8 and 17, participants return to the site for replacement of the cCGM devices.
During the study, participants will be instructed to test their blood glucose a minimum of 8 times daily (more if required) and record all values. The study ends after completing the final study visit on day 23, including return of all study devices and completion of a questionnaire on the functionality of the nCGM system. 14 days after the final study visit, participants will receive a follow-up phone call by the study team to capture any health concerns potentially related to the study.
Intervention code [1] 328687 0
Treatment: Devices
Comparator / control treatment
Glucose data collected from the nCGM system will be compared to glucose data simultaneously collected with cCGM and SMBG. As the reference standard, SMBG via capillary blood sampling will function as the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 338356 0
%20/20 accuracy of nCGM
Timepoint [1] 338356 0
End of study on day 23 post-intervention commencement
Secondary outcome [1] 435586 0
Accuracy of nCGM
Timepoint [1] 435586 0
End of study on day 23 post-intervention commencement
Secondary outcome [2] 435587 0
Accuracy of nCGM
Timepoint [2] 435587 0
End of study on day 23 post-intervention commencement
Secondary outcome [3] 435588 0
Accuracy of nCGM
Timepoint [3] 435588 0
End of study on day 23 post-intervention commencement
Secondary outcome [4] 435589 0
Accuracy of nCGM
Timepoint [4] 435589 0
End of study on day 23 post-intervention commencement
Secondary outcome [5] 435590 0
Accuracy of nCGM
Timepoint [5] 435590 0
End of study on day 23 post-intervention commencement
Secondary outcome [6] 435591 0
Accuracy of nCGM
Timepoint [6] 435591 0
End of study on day 23 post-intervention commencement
Secondary outcome [7] 435592 0
Accuracy of nCGM
Timepoint [7] 435592 0
End of study on day 23 post-intervention commencement
Secondary outcome [8] 435593 0
Accuracy of nCGM
Timepoint [8] 435593 0
End of study on day 23 post-intervention commencement
Secondary outcome [9] 435594 0
Accuracy of nCGM
Timepoint [9] 435594 0
End of study on day 23 post-intervention commencement
Secondary outcome [10] 435595 0
Accuracy of nCGM
Timepoint [10] 435595 0
End of study on day 23 post-intervention commencement
Secondary outcome [11] 435596 0
Accuracy of nCGM
Timepoint [11] 435596 0
End of study on day 23 post-intervention commencement
Secondary outcome [12] 435597 0
Accuracy of nCGM
Timepoint [12] 435597 0
End of study on day 23 post-intervention commencement
Secondary outcome [13] 435598 0
Accuracy of nCGM
Timepoint [13] 435598 0
End of study on day 23 post-intervention commencement
Secondary outcome [14] 435599 0
Accuracy of nCGM
Timepoint [14] 435599 0
End of study on day 23 post-intervention commencement
Secondary outcome [15] 435600 0
Precision of nCGM
Timepoint [15] 435600 0
End of study on day 23 post-intervention commencement
Secondary outcome [16] 435601 0
Hypoglycemia alert performance
Timepoint [16] 435601 0
End of study on day 23 post-intervention commencement
Secondary outcome [17] 435605 0
Hypoglycemia alert performance
Timepoint [17] 435605 0
End of study on day 23 post-intervention commencement
Secondary outcome [18] 435606 0
Hyperglycemia alert performance
Timepoint [18] 435606 0
End of study on day 23 post-intervention commencement
Secondary outcome [19] 435607 0
Hyperglycemia alert performance
Timepoint [19] 435607 0
End of study on day 23 post-intervention commencement
Secondary outcome [20] 435608 0
Hypoglycemia detection rate
Timepoint [20] 435608 0
End of study on day 23 post-intervention commencement
Secondary outcome [21] 435609 0
Hypoglycemia detection rate
Timepoint [21] 435609 0
End of study on day 23 post-intervention commencement
Secondary outcome [22] 435610 0
Hyperglycemia detection rate
Timepoint [22] 435610 0
End of study on day 23 post-intervention commencement
Secondary outcome [23] 435611 0
Hyperglycemia detection rate
Timepoint [23] 435611 0
End of study on day 23 post-intervention commencement
Secondary outcome [24] 435613 0
nCGM sensor life
Timepoint [24] 435613 0
End of study on day 23 post-intervention commencement
Secondary outcome [25] 435614 0
nCGM sensor life
Timepoint [25] 435614 0
End of study on day 23 post-intervention commencement
Secondary outcome [26] 435615 0
nCGM sensor life
Timepoint [26] 435615 0
End of study on day 23 post-intervention commencement
Secondary outcome [27] 435618 0
nCGM lag time
Timepoint [27] 435618 0
End of study on day 23 post-intervention commencement
Secondary outcome [28] 435619 0
nCGM system satisfaction
Timepoint [28] 435619 0
End of study on day 23 post-intervention commencement
Secondary outcome [29] 435620 0
Safety endpoints
Timepoint [29] 435620 0
Assessed for 37 days from study day 1 throughout the duration of the study and for up to 14 days after study completion.
Secondary outcome [30] 435621 0
Technical endpoints
Timepoint [30] 435621 0
Assessed for 21 days from study day 2 (post-intervention commencement) throughout the duration of the study until day 23 post-intervention commencement.

Eligibility
Key inclusion criteria
1. Children and adolescents who are 7 to 17 years of age (inclusive).
2. Adults who are 18 years of age or older.
3. Participants with type 1 diabetes, or with type 2 diabetes and on more than one anti-diabetic medication.
4. Participants who voluntarily decide to participate in the study and provide written informed consent.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Potential participants older than = 45 years with more than 2 further cardiovascular risk factors (see factors a-c below) will be excluded from study entry:
a.) Current Smoker.
b.) hypertension (>150 / 80 mmHg).
c.) HbA1c > 9.0 %.
2. Participants with the following uncontrolled abnormal skin/skin diseases at the CGM sensor attachment sites including but not limited to:
• Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash and Staphylococcus aureus infection.
3. Participants with moderate/severe allergic contact dermatitis to medical adhesives.
4. Participants with severe hypoglycemia events within 6 months prior to screening. Severe hypoglycemia refer to loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia
5. Participants with >1 episode of diabetic ketoacidosis within the past 6 months prior to screening.
6. Participants with cerebrovascular diseases or the following cardiovascular diseases (but not limited to) when instable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy including but not limited to:
• Ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease and serious arrhythmia.
7. Diagnosis of epilepsy or adrenal disorders, or episode/s of syncope within 6 months prior to screening.
8. Participants with chronic infectious disease.
9. Participants with anemia (hemoglobin below laboratory-determined normal range for age and sex).
10. Participants scheduled for unchangeable X-ray, Magnetic resonance imaging, or computed tomography scan during the study.
11. Pregnant or lactating women. Urine pregnancy test screening to be conducted on all pre-menopausal women.
12. Participants who are currently participating or participated within 2 weeks before screening in another study or plan to participate in another study that in the opinion of the investigator would affect the safety of the study participant or the study results.
13. Participants unwilling to abstain from use of nutritional supplements containing xylose.
14. Participants with cognitive impairment or who are not suitable for this study or may be at increased risk associated with study participation in the opinion of the investigator.
15. Wearing of a pacemaker or other comparable medical devices.
16. Employees or family members of the sponsor or the clinical investigator.
17. History of frequent catheter abscesses associated with pump therapy.

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



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26348 0
New Zealand
State/province [1] 26348 0

Funding & Sponsors
Funding source category [1] 316612 0
Commercial sector/Industry
Name [1] 316612 0
i-SENS, Inc.
Country [1] 316612 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
i-SENS, Inc.
Address
Country
Korea, Republic Of
Secondary sponsor category [1] 318796 0
None
Name [1] 318796 0
Address [1] 318796 0
Country [1] 318796 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315398 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315398 0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Ethics committee country [1] 315398 0
New Zealand
Date submitted for ethics approval [1] 315398 0
29/05/2024
Approval date [1] 315398 0
Ethics approval number [1] 315398 0
2024 FULL 20521

Summary
Brief summary
The primary objective of this single-arm study is to evaluate the efficacy of the investigational CGM device by assessing the glucose values measured with this device, in comparison with the reference standard, which is blood glucose monitored by capillary blood. We will also assess the safety of this device in children and adults with type 1 and type 2 diabetes by observing adverse events that may occur during the study period. Importantly, the CGM devices will not be used for any therapeutic decision-making. The study will enrol 50 children and adolescents (aged 7-17 years, inclusive) and 50 adults (aged 18 years and over) with type 1 and type 2 diabetes. Participants will be involved in the study for up to 51 days. Participants will wear the investigational CGM device together with another already commercially available CGM device for 21 days. During this time, participants will perform daily finger prick blood glucose monitoring at home. At the end of the study, all devices will be returned and participants will undergo a final safety assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134578 0
Prof Benjamin J Wheeler
Address 134578 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 134578 0
New Zealand
Phone 134578 0
+64 274701980
Fax 134578 0
Email 134578 0
[email protected]
Contact person for public queries
Name 134579 0
Benjamin J Wheeler
Address 134579 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 134579 0
New Zealand
Phone 134579 0
+64 274701980
Fax 134579 0
Email 134579 0
[email protected]
Contact person for scientific queries
Name 134580 0
Benjamin J Wheeler
Address 134580 0
Department of Women's and Children's Health Otago Medical School - Dunedin Campus PO Box 56 Dunedin 9054 New Zealand
Country 134580 0
New Zealand
Phone 134580 0
+64 274701980
Fax 134580 0
Email 134580 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
Data will go directly into commercially sensitive device development by the device manufacturer.


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.