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Trial registered on ANZCTR


Registration number
ACTRN12622000290796
Ethics application status
Approved
Date submitted
16/12/2021
Date registered
15/02/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the efficacy and safety of a new Continuous Glucose Monitoring System in adult patients with type 1 and type 2 diabetes
Scientific title
A prospective, single arm, open-label, interventional, pivotal study to evaluate the efficacy and safety of a novel Continuous Glucose Monitoring System in adult patients with type 1 and type 2 diabetes
Secondary ID [1] 306063 0
None
Universal Trial Number (UTN)
U1111-1271-7100
Trial acronym
Linked study record
The current trial is a follow-up study to ACTRN12621000836831.

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 324709 0
Type 2 Diabetes 324710 0
Condition category
Condition code
Metabolic and Endocrine 322158 322158 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, single arm, open-label, interventional, confirmatory study to evaluate the efficacy and safety of a novel continuous glucose monitoring (CGM) system by evaluating the glucose measured in comparison with the reference standard, which is venous blood glucose, and to demonstrate the safety of the novel CGM system (from here onwards referred to as nCGM) by observing adverse events occurring during the attachment of the device in adult patients with type 1 and type 2 diabetes. The study will enrol 50 adults (18 years and over).
The nCGM system consists of (1) an interstitial glucose sensor worn in the upper arm that continuously measures the glucose concentration in the interstitial fluid, (2) a transmitter that transfers the results wirelessly and (3) a handheld receiver (mobile phone) that receives and displays the sensor glucose data, including the current glucose level, glucose history and a predicted glucose trend. The nCGM can be worn for up to 15 days. Participants will not use the investigational device to make clinical or treatment decisions.
Subjects will be involved in the study for 16 days and will visit the study site 5 times during the study. Subjects will wear nCGM for 15 days to monitor their glucose values while maintaining their usual treatment method. All subjects will wear 2 nCGM devices, one on each upper arm. Subjects will calibrate the nCGM devices once every 12 hours during the first 24 hours of the study, and thereafter once every 24 hours using a self-monitoring of blood glucose device (blood glucometer, hereafter referred to as SMBG). During the study period, subjects will draw capillary blood at least 8 times a day using SMBG and record the results.
On day 1 of the study, subjects will receive training on the use of the nCGM system and SMBG device for measuring of capillary blood glucose, and will be instructed to keep a daily blood glucose log. The training on the use of the study devices will be done by trained members of the study team and take approximately 30 minutes. Subjects will be assigned to an ‘early group’ or ‘late group’ based on their personal preferences. Those in the early group will visit the study site on days 1, 5, 10, 15 and 16, and those in the late group will visit the clinic on days 1, 2, 5, 10 and 16. On site on days 1/2, 5, 10 and 15/16, subjects will undergo safety assessments and have venous blood sampling every 15 min for approximately 8 hours using an intravenous catheter, and capillary blood sampling using SMBG will be done in parallel. During 4 of these in-clinic days, glucose excursions will be induced by consumption of a high-glycaemic index (HGI) meal, and delayed and increased insulin boluses. The HGI meal will account for approx. 20% of daily caloric needs with a composition of around 65% carbohydrates, 15% protein, 20% fat. The HGI meal will have low fibre content and be adapted to local customs and dietary requirements, and include one serving of fruit juice. Subjects will be closely monitored by trained study staff experienced in medical care during these glucose excursions, in order to ensure subject safety.
At home, subjects will be instructed to test their blood glucose at least 8 times daily and record all values. After the in-clinic procedures on day 5, subjects will continue to perform blood glucose testing every 2-3 hours, including overnight, until the morning of day 6.
The study ends after completing the in-clinic blood sampling on day 16, when subjects remove the nCGM devices, complete a device satisfaction questionnaire, and undergo a final safety assessment. Subjects will receive a follow-up phone call by a member of the study team 14 days after study completion.
Intervention code [1] 322470 0
Treatment: Devices
Comparator / control treatment
Sensor glucose data collected from the nCGM sensors will be compared to blood glucose data simultaneously collected with SMBG. Further, as the reference standard, venous blood glucose taken via an intravenous catheter will function as the reference comparator.
Control group
Active

Outcomes
Primary outcome [1] 329928 0
Accuracy of nCGM as determined by comparing the relative difference between glucose values collected with nCGM to comparator method 1 (venous blood glucose).
Timepoint [1] 329928 0
End of study at 16 days.
Secondary outcome [1] 404309 0
Accuracy of nCGM as determined by comparing the relative difference between glucose values collected with nCGM to comparator method 2 (capillary blood glucose).
Timepoint [1] 404309 0
End of study at day 16.
Secondary outcome [2] 404310 0
nCGM system satisfaction
Timepoint [2] 404310 0
End of study at 16 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 [3] 404311 0
Safety endpoints – incidence of adverse events and adverse device effects as reported by participants or study staff during clinical examinations, or self-reported by participants and recorded by research staff at any point throughout the study. Examples for adverse events or adverse device effects include local allergic contact dermatitis, transient pain while wearing the nCGM system, irritant dermatitis, bleeding due to wearing the system.
Timepoint [3] 404311 0
Assessed for 30 days from enrollment on study day 1; throughout the duration of the study and for 14 days after study completion.
Secondary outcome [4] 404312 0
Accuracy of nCGM system as determined by comparing mean absolute relative difference (MARD) between glucose values collected with nCGM to comparator method 1 (venous blood glucose).
Timepoint [4] 404312 0
End of study at 16 days.
Secondary outcome [5] 404313 0
Accuracy of nCGM system as determined by comparing mean relative difference (MRD) between glucose values collected with nCGM to comparator method 1 (venous blood glucose).
Timepoint [5] 404313 0
End of study at 16 days
Secondary outcome [6] 404314 0
Accuracy of nCGM system as determined by comparing mean absolute difference (MAD) between glucose values collected with nCGM to comparator method 1 (venous blood glucose).
Timepoint [6] 404314 0
End of study at 16 days
Secondary outcome [7] 404315 0
Accuracy of nCGM system as determined by comparing mean difference (MD) between glucose values collected with nCGM to comparator method 1 (venous blood glucose).
Timepoint [7] 404315 0
End of study at 16 days.
Secondary outcome [8] 404316 0
Percentage nCGM values in Zone A and Zone B of Consensus Error Grid when nCGM versus venous blood glucose values are shown.
Timepoint [8] 404316 0
End of study at 16 days
Secondary outcome [9] 404317 0
Alert performance as measured by hypoglycaemia detection/missed detection rate comparing nCGM and venous blood glucose values.
Timepoint [9] 404317 0
End of study at 16 days
Secondary outcome [10] 404318 0
Alert performance as measured by hyperglycaemia detection/missed detection rate comparing nCGM and venous blood glucose values.
Timepoint [10] 404318 0
End of study at 16 days
Secondary outcome [11] 404319 0
nCGM system calibration stability as determined by percentage accuracy comparing nCGM versus capillary blood glucose values at 2-hour interval for 24 hours following nCGM system calibration.
Timepoint [11] 404319 0
End of study at 16 days
Secondary outcome [12] 404321 0
nCGM sensor life as determined by total number of nCGM measurements during the CGM wear time.
Timepoint [12] 404321 0
End of study at 16 days
Secondary outcome [13] 404322 0
Lag time as determined by difference (in minutes) between venous blood glucose measurement and display time of nCGM values.
Timepoint [13] 404322 0
End of study at 16 days
Secondary outcome [14] 406263 0
Alert performance as measured by hypoglycaemia true/false alert rate comparing nCGM and venous blood glucose values.
Timepoint [14] 406263 0
End of study at 16 days.
Secondary outcome [15] 406264 0
Alert performance as measured by hyperglycaemia true/false alert rate comparing nCGM and venous blood glucose values.
Timepoint [15] 406264 0
End of study at 16 days
Secondary outcome [16] 406265 0
nCGM sensor life as determined by duration of days of nCGM devices working during the CGM wear time.
Timepoint [16] 406265 0
End of study at 16 days
Secondary outcome [17] 406266 0
Accuracy of nCGM system as determined by comparing mean absolute relative difference (MARD) between glucose values collected with nCGM to comparator method 2 (capillary blood glucose).
Timepoint [17] 406266 0
End of study at 16 days
Secondary outcome [18] 406267 0
Accuracy of nCGM system as determined by comparing mean relative difference (MRD) between glucose values collected with nCGM to comparator method 2 (capillary blood glucose).
Timepoint [18] 406267 0
End of study at day 16
Secondary outcome [19] 406268 0
Accuracy of nCGM system as determined by comparing mean absolute difference (MAD) between glucose values collected with nCGM to comparator method 2 (capillary blood glucose).
Timepoint [19] 406268 0
End of study at 16 days
Secondary outcome [20] 406269 0
Accuracy of nCGM system as determined by comparing mean difference (MD) between glucose values collected with nCGM to comparator method 2 (capillary blood glucose).
Timepoint [20] 406269 0
End of study at 16 days

Eligibility
Key inclusion criteria
1. Adults who are 18 years of age or above
2. Patients with type 1 and type 2 diabetes who use intensive insulin therapy with known dosing parameters and at least one of the following two options of insulin requirements:
-at least 2 injections daily, or
-at least 0.2 units of insulin/kg/day
3. Patients who voluntarily decide to participate in the study and provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Potential subjects older than 45 years with more than 2 further cardiovascular risk factors (see factors a-c below) will be excluded from study entry:
a.) Smoker
b.) Arterial hypertension (greater than 150 / 80 mmHg)
c.) HbA1c greater than 9.0 %
2. Patients with the following uncontrolled abnormal skin/skin diseases at the CGM sensor attachment site: Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash, Staphylococcus aureus infection, etc.
3. Patients with moderate/severe allergic contact dermatitis to medical adhesives
4. Patients with severe hypoglycemia events within 6 months prior to screening
Severe hypoglycemia: Loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia
5. Patients with more than 1 episode of diabetic ketoacidosis within the past 6 months prior to screening
6. Patients 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:
Ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease, serious arrhythmia, etc.
7. Patients with epilepsy, syncope, or adrenal disorders within 6 months prior to screening
8. Patients with chronic infectious disease
9. Patients with anemia (hemoglobin below laboratory determinded normal range for age and sex).
10. Patients scheduled for unchangeable X-ray, MRI, or CT during the study
11. Pregnant, lactating women or those who plan to become pregnant or do not agree to use an adequate method of contraception during the study
12. Patients who are currently participating or participated within 2 weeks prior to 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 subject or the study result
13. Patients unwilling to abstain from use of nutritional supplements containing xylose
14. Patients 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 pace maker or other comparable medical devices
16. Dependency from the sponsor or the clinical investigator
17. Hypoglycemia unawareness
18. 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
Other
Other design features
Participants are assigned to receiving multiple interventions by wearing a CGM device and performing frequent capillary and repeated venous 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
Completed
Date of first participant enrolment
Anticipated
14/03/2022
Actual
30/05/2022
Date of last participant enrolment
Anticipated
Actual
7/06/2023
Date of last data collection
Anticipated
Actual
12/07/2023
Sample size
Target
50
Accrual to date
Final
69
Recruitment outside Australia
Country [1] 24453 0
New Zealand
State/province [1] 24453 0
Otago

Funding & Sponsors
Funding source category [1] 310399 0
Commercial sector/Industry
Name [1] 310399 0
i-SENS, Inc.
Country [1] 310399 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] 311552 0
None
Name [1] 311552 0
Address [1] 311552 0
Country [1] 311552 0
Other collaborator category [1] 282159 0
Commercial sector/Industry
Name [1] 282159 0
Zenith Technology Corporation
Address [1] 282159 0
156 Frederick Street,
Dunedin North,
Dunedin 9016
Country [1] 282159 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310048 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 310048 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 310048 0
New Zealand
Date submitted for ethics approval [1] 310048 0
05/12/2021
Approval date [1] 310048 0
18/02/2022
Ethics approval number [1] 310048 0
2021 FULL 11796

Summary
Brief summary
The primary objective of this single-arm study is to investigate the efficacy and safety 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 venous blood. We will also assess the safety of this device in patients 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 adults (aged 18 years and over) with type 1 and type 2 diabetes. Participants will be involved in the study for 16 days. Participants will wear the investigational CGM device for 15 days. During this time, participants will perform daily finger prick blood glucose monitoring at home. On days 1/2, 5, 10 and 15/16 of the study, participants will undergo capillary and 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 116306 0
A/Prof Benjamin J Wheeler
Address 116306 0
Women's and Children's Health
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9013
Country 116306 0
New Zealand
Phone 116306 0
+64 274701980
Fax 116306 0
Email 116306 0
[email protected]
Contact person for public queries
Name 116307 0
Benjamin J Wheeler
Address 116307 0
Women's and Children's Health
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9013
Country 116307 0
New Zealand
Phone 116307 0
+64 274701980
Fax 116307 0
Email 116307 0
[email protected]
Contact person for scientific queries
Name 116308 0
Benjamin J Wheeler
Address 116308 0
Women's and Children's Health
Dunedin School of Medicine
University of Otago
201 Great King Street
Dunedin 9013
Country 116308 0
New Zealand
Phone 116308 0
+64 274701980
Fax 116308 0
Email 116308 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.