Algorithm optimization of a new continuous glucose monitoring system in children, adolescents and adult patients with type 1 diabetes – A pilot study.

• Register: ANZCTR
• Last refreshed on: 12 July 2021
• Main ID: ACTRN12621000836831
• Date of registration: 30/06/2021
• Prospective Registration: Yes
• Primary sponsor: i-SENS, Inc.
• 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
• Date of first enrolment: 02/08/2021
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12621000836831.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

New Zealand

Contacts

• Name: A/Prof Benjamin J Wheeler

• Name: A/Prof Benjamin J Wheeler

Key inclusion & exclusion criteria

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)

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.

Age minimum: 2 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Type 1 diabetes;
Type 1 diabetes

Intervention(s)

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 SMB

Primary Outcome(s)

Accuracy of nCGM as determined by comparing the relative difference between glucose values collected with nCGM to aCGM and capillary blood glucose. [End of the study at 15 days]

Secondary Outcome(s)

Accuracy of nCGM as determined by the percentage of nCGM glucose readings within +/- 15% of ranges measured with aCGM and capillary blood glucose.

[End of the study at 15 days.]

nCGM satisfaction[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.]

Precision of nCGM as determined by comparing the glucose data measured with two nCGM devices (in subjects wearing 2 nCGM concurrently).
[End of the study at 15 days.]

Safety endpoints – local cutaneous adverse events as reported by participants and recorded by research staff throughout the study.[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. ]

Secondary ID(s)

None

Source(s) of Monetary Support

i-SENS, Inc.

Ethics review

Status: Approved
Approval date: 02/07/2021
Contact:

Northern B Health and Disability Ethics Committee