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Trial registered on ANZCTR


Registration number
ACTRN12621000836831
Ethics application status
Approved
Date submitted
7/05/2021
Date registered
30/06/2021
Date last updated
6/07/2021
Date data sharing statement initially provided
30/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Algorithm optimization of a new continuous glucose monitoring system in children, adolescents and adult patients with type 1 diabetes – A pilot study.
Scientific title
A prospective, monocenter, single arm, open-label study to collect data for algorithm optimization of a novel continuous glucose monitoring system in children, adolescents and adult patients with type 1 diabetes
Secondary ID [1] 304169 0
None
Universal Trial Number (UTN)
U1111-1265-5941
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 321852 0
Condition category
Condition code
Metabolic and Endocrine 319579 319579 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, single arm, open label study is to collect data for algorithm optimization 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 aCGM) and the reference standard which is capillary blood glucose in children, adolescents and adult patients with type 1 diabetes. The study will enrol 15 children and adolescents (2-17 years of age) and 15 adults (18 years and over).
The novel CGM system consists of an interstitial glucose sensor worn in the upper arm continuously for up to 15 days, which is scanned by a hand-held reader to display glucose data, including the current glucose level 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 aCGM and nCGM consist of (1) a sensor worn on the upper arm that measures the glucose concentration in the interstitial fluid, (2) a transmitter that send the results wirelessly and (3) a handheld receiver (e.g. mobile phone), that receives and displays the glucose data. While aCGM can be worn for up to 10 days, nCGM can be worn for up to 15 days.
Subjects are involved in the study for 15 days. To ensure that the study procedures are feasible and no safety signals are present, the initial 5 subjects will be adults aged 18 years and over, before the study commences in younger participants. Subjects will wear nCGM for 15 days to monitor the glucose values while maintaining their usual treatment method.
On day 1 of the study, subjects will receive training on the use of the CGM devices and the self-monitoring 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. The training on the use of the CGM devices will be done by a trained member of the research team and take approximately 30 minutes. Depending on the age group, subjects will wear between 1 – 3 CGM devices simultaneously. Those < 8 years old, 1 nCGM device, and on the consent of the parent/guardian, 1 additional aCGM device (up to 2 devices in total). For 8-12 age group, 1 nCGM sensor (+ 1 additional if consented) and 1 aCGM sensor (up to 3 devices in total), and for age group >= 13 years, 2 nCGM sensors and 1 aCGM sensor will be worn (3 devices in total). All procedures at the clinic will be performed by trained nurses, who are involved in the study. After putting on the CGM devices on day 1, and again when subjects re-visit the clinic on days 8 and 16, the subjects will perform blood sampling every 15 - 30 min for 2-8 hours, depending on their age (30-minute interval sampling for 2 hours for those <8 year old; 15-minute interval sampling for 4 hours for 8-12 year olds; for 6 hours for 13-17 year olds, for 8 hours for >=18 year olds). On these days, capillary blood will be taken from all subjects via fingerprick, and additionally venous blood will be taken for cobas measurements (CM) from subjects >= 8 years of age, if specific consent is given.
Subjects will calibrate all CGM devices once every 12 hours during the first day of the study (Day 1), and thereafter once every 24 hours (days 2 to 16), using SMBG. At home on days 2-7 and 9-15, subjects will conduct SMBG measurements and fill out their daily blood glucose log. These SMBG measurements will be in total conducted 8 – 25 times a day, depending on the subject’s age and the day during the clinical trial. At home, subjects will be instructed to test their blood glucose 8 times daily (more if required) and record all values. On days 4, 7 and 13, subjects will additionally perform cluster testing as followed: 2-7 year-olds 60-min interval SMBG testing for 4 hours; 8-12 year-olds 30-min SMBG testing for 4 hours, 13 years and over 15-min interval SMBG testing for 4 hours. The study ends after completing the in-clinic blood sampling and final safety assessments on day 16.
Intervention code [1] 320491 0
Treatment: Devices
Comparator / control treatment
Glucose data collected from the nCGM sensors will be compared to glucose data simultaneously collected with aCGM and SMBG. As the reference standard, SMBG via capillary blood sampling will function as the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 327440 0
Accuracy of nCGM as determined by comparing the relative difference between glucose values collected with nCGM to aCGM and capillary blood glucose.
Timepoint [1] 327440 0
End of the study at 15 days
Secondary outcome [1] 395135 0
Accuracy of nCGM as determined by the percentage of nCGM glucose readings within +/- 15% of ranges measured with aCGM and capillary blood glucose.

Timepoint [1] 395135 0
End of the study at 15 days.
Secondary outcome [2] 395136 0
Precision of nCGM as determined by comparing the glucose data measured with two nCGM devices (in subjects wearing 2 nCGM concurrently).
Timepoint [2] 395136 0
End of the study at 15 days.
Secondary outcome [3] 395137 0
nCGM satisfaction
Timepoint [3] 395137 0
End of study at 15 days, as measured by completion of a user satisfaction questionnaire which was developed by the device manufacturer specifically for purposes of this study.
Secondary outcome [4] 395138 0
Safety endpoints – local cutaneous adverse events as reported by participants and recorded by research staff throughout the study.
Timepoint [4] 395138 0
Assessed for 29 days from enrollment on study day 1; throughout the duration of the study and for up to 14 days after study completion.

Eligibility
Key inclusion criteria
1. Aged 2 years and over
2. Patient with Type 1 Diabetes
3. Patient and/or their parent(s)/guardian(s) (if applicable) are able to speak, read, and write English
4. Participant agrees to participate in the study by giving informed consent/assent (as applicable)
5. Parent(s)/guardian(s) agree to participate in the study by giving signed informed consent (if applicable)
Minimum age
2 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of abnormal skin/skin diseases at the sensor attachment site e.g. Extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, severe rash, Staphylococcus aureus infection, etc.
2. Known moderate to severe allergy to medical adhesives
3. Diagnosed with any chronic medical, psychiatric, developmental/behavioral condition that at the discretion of the investigator would affect their performance in the study.
4. Patient scheduled for X-ray, MRI, CT scan, radiofrequency ablation, high-frequency electrical heat, or MR-guided focused ultrasound during the study period that cannot be rescheduled
5. Pregnancy (females aged greater than or equal to 14 years will have urine pregnancy test).
6. Participation in an investigational study (drug or device) within 2 weeks prior to screening or is planning to participate in another study during the study period that at the discretion of the investigator would impair the results of this investigational study.

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



Intervention assignment
Other
Other design features
Participants are assigned to receiving multiple interventions by wearing two types of CGM devices (nCGM and aCGM) and performing frequent capillary blood sampling.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All statistical analyses will be performed using the SAS Software (Version 9.4), in which descriptive statistics (mean, standard deviation, median, minimum, and maximum) will be presented for continuous data and frequency and percentage (%) will be presented for categorical data. More details will be presented, if necessary.

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 23681 0
New Zealand
State/province [1] 23681 0
Otago

Funding & Sponsors
Funding source category [1] 308530 0
Commercial sector/Industry
Name [1] 308530 0
i-SENS, Inc.
Address [1] 308530 0
i-SENS Building,
43, Banpo-daero 28-gil, Seocho-gu,
Seoul, 06646,
Republic of Korea
Country [1] 308530 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
i-SENS, Inc.
Address
i-SENS Building,
43, Banpo-daero 28-gil, Seocho-gu,
Seoul, 06646,
Republic of Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 309387 0
None
Name [1] 309387 0
Address [1] 309387 0
Country [1] 309387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308485 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 308485 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 308485 0
New Zealand
Date submitted for ethics approval [1] 308485 0
22/04/2021
Approval date [1] 308485 0
02/07/2021
Ethics approval number [1] 308485 0
21/NTB/112

Summary
Brief summary
The primary objective of this single-arm study is to investigate 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 and venous blood. The collected data will be used to for algorithm optimisation to improve the functioning and accuracy of the new CGM system. We will also assess the safety of this device in patients with type 1 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 15 children and adolescents (aged 2-17 years, inclusive) and 15 adults (aged 18 years and over) with type 1 diabetes. Participants will be involved in the study for 15 days. Participants will wear the investigational CGM device together with another already commercially available CGM device for 15 days. During this time, participants will perform daily finger prick blood glucose monitoring at home. On days 1, 8 and 16 of the study, participants will undergo capillary and, on consent, venous blood sampling in the clinic, in order to assess the accuracy of the investigational device. 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 110862 0
A/Prof Benjamin J Wheeler
Address 110862 0
Women's and Children's Health
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9013
Country 110862 0
New Zealand
Phone 110862 0
+64 274701980
Fax 110862 0
Email 110862 0
ben.wheeler@otago.ac.nz
Contact person for public queries
Name 110863 0
A/Prof Benjamin J Wheeler
Address 110863 0
Women's and Children's Health
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9013
Country 110863 0
New Zealand
Phone 110863 0
+64 274701980
Fax 110863 0
Email 110863 0
ben.wheeler@otago.ac.nz
Contact person for scientific queries
Name 110864 0
A/Prof Benjamin J Wheeler
Address 110864 0
Women's and Children's Health
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9013
Country 110864 0
New Zealand
Phone 110864 0
+64 274701980
Fax 110864 0
Email 110864 0
ben.wheeler@otago.ac.nz

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 algorithm development by the device manufacturer.
What supporting documents are/will be available?
No other documents available
Summary results
No Results