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Trial registered on ANZCTR


Registration number
ACTRN12620001161910
Ethics application status
Approved
Date submitted
22/09/2020
Date registered
5/11/2020
Date last updated
5/11/2020
Date data sharing statement initially provided
5/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Medtronic extended-life glucose sensor in people with diabetes
Scientific title
Evaluation of the accuracy of a Novel Medtronic Extended Life Continuous Glucose Sensor in people with type 1 diabetes
Secondary ID [1] 302367 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 319150 0
Condition category
Condition code
Metabolic and Endocrine 317110 317110 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this research study is to collect data about the performance of a Medtronic extended-life continuous glucose sensor over a 17-day period. The investigational sensor will always be blinded, meaning that participants will not see any glucose information from the investigational sensor. Although information about glucose levels will be obtained by the device during this study, the information will not be available to participants. This means that participants will manage their diabetes as normal throughout the period of the study, and the participants role as a study volunteer is to test the longevity of the investigational device. If participants are currently using a commercial CGM device, they may continue with its use during the study in addition to the investigational sensor(s).
Participation in this research study will occur over approximately 18 days. Participants will be required to attend the clinical trials centre at St Vincent’s Hospital, Melbourne on at least 6 occasions and potentially up to 8 occasions. The amount of study visits will be determined at the beginning of the study via randomization as described below. Participants in this project will need to be over 18 years of age, have been diagnosed with type 1 diabetes, and be currently using or have experience with continuous glucose monitoring devices.
The first visit to the clinical trials centre will be a screening session and will take approximately 2-4 hours, where we will obtain written consent, medical history and collect some personal and physical data (such as height and weight). If participants meet all of the criteria for the study, they will have the investigational device/s inserted by the study nurse.
Participants will be randomly allocated to one of 6 groups which will determine the number of investigational sensors to be worn, and the location on the body that the sensors will be placed. Either 2 or 3 investigational sensors inserted for the duration of the study depending on the which group the participant is allocated to, and sensors will be placed on either the arm or abdomen, or a combination of arm and abdomen. One sensor will be a “control” sensor not containing the anti-inflammatory drug Dexamethasone, and the remaining 1-2 sensors will contain Dexamethasone. Dexamethasone is a common anti-inflammatory drug used in many medical devices. Four blood samples will be taken during this screening session, to determine participants' glucose control by HbA1c and levels of dexamethasone in the blood.
For the duration of the trial, participants will be required to perform at least 8 fingerprick glucose tests per day and record this in a diary. Additionally, participants will attend the clinical trials centre on four occasions after sensor insertion to perform a ~6 hour meal test. The meal test procedure is considered a routine procedure during research studies evaluating the performance of medical devices intended to monitor or measure blood glucose. The purpose of these sessions is to benchmark the performance of the investigational sensor to blood glucose samples obtained throughout this procedure. Depending on which group participants have been randomly assigned to, they will attend the clinical trials centre 1-, 3-, 7- and 10-days after the screening session or 2-, 7-, 10- and 15-days after the screening session. On these four occasions participants will attend the CTC at ~7.30AM prior to breakfast and will be given a standardised test meal containing 65 grams of carbohydrate. Participants will use their normal insulin regime, administered immediately prior to the meal. Blood samples will be taken from an intravenous catheter (an “IV”; a thin tube placed in a vein) every 20 minutes for 6-hours to measure glucose and compare to the readings obtained by the investigational CGM. Approximately 20 samples will be taken, totalling ~50mLs of blood.
Participants will also be required to attend the trials centre on days 1, 3, 7 and 15 or 1, 3, 7 and 10 (depending on the group that participants were randomly allocated to) to provide a ~5-10mL blood sample for the measurement of dexamethasone in the blood. Where these dates overlap with the date of the meal test, the blood sample will be taken upon arrival and before the meal test is started. Where these dates do not overlap with a meal test, participants will attend the trials centre for ~10-15min to provide the blood sample.
At each study visit, the researchers will ask participants to bring their study diary to monitor adherence for fingerprick sampling, and the sensor data will be downloaded.
The end of study visit will occur on Day 17 and will include final assessments and collection of the investigational CGM devices, and any adverse events or concerns of participants may be discussed with the study staff and doctor.
Intervention code [1] 318653 0
Treatment: Devices
Comparator / control treatment
The investigational "extended-life" glucose sensors containing dexamethasone will be compared to a "control" sensor which does not contain dexamethasone.
Control group
Active

Outcomes
Primary outcome [1] 325197 0
Accuracy of sensor glucose data performance provided by the Medtronic Extended Life glucose sensor (subcutaneously measured glucose) will be compared with meter glucose (blood glucose) and YSI glucose (plasma glucose) values obtained during meal tests as references.
Timepoint [1] 325197 0
Day 1, Day 2, Day 3, Day 7, Day 10 and Day 15 post-sensor insertion
Secondary outcome [1] 387155 0
Accuracy of sensor glucose data provided by the "control" sensor (subcutaneously measured glucose) compared with meter glucose (blood glucose) and YSI glucose (plasma glucose) values as references.
Timepoint [1] 387155 0
Day 1, Day 2, Day 3, Day 7, Day 10 and Day 15 post-sensor insertion
Secondary outcome [2] 387156 0
Sensor insertion site appearance on Day 17 of the Dexamethasone sensor and control nominal sensor.
Timepoint [2] 387156 0
Day 17 post-sensor insertion
Secondary outcome [3] 387157 0
Plasma Dexamethasone levels at pre-specified study time-points
Timepoint [3] 387157 0
Day 1, Day 2, Day 3, Day 7, Day 10 and Day 15 post-sensor insertion

Eligibility
Key inclusion criteria
Participants will be considered for inclusion in the study if they meet all the following criteria:
1. Participant is over 18 years of age at time of screening.
2. A clinical diagnosis of Type-1 Diabetes, as determined by the Investigator.
3. Participant is using insulin to treat his/her Diabetes.
4. Currently using a sensor or has experience with sensor use.
5. Preference will be given to subjects who have a history of hypoglycaemia.
6. Participant is willing to comply with all requirements associated with the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study for any of the following reasons:
1. Participant has a positive pregnancy screening test.
2. Any known allergies to glucocorticoid steroids
3. Participant is female and plans to become pregnant during the study.
4. Participant is unable to tolerate tape adhesive in the region of sensor placement.
5. Participant has any unresolved adverse skin condition in the region of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
6. Recent (< 3months) episode of severe hypoglycaemia or Diabetic ketoacidosis.
7. Known major life-threatening disease or psychiatric illness.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306797 0
Commercial sector/Industry
Name [1] 306797 0
Medtronic
Country [1] 306797 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 307349 0
None
Name [1] 307349 0
Nil
Address [1] 307349 0
Nil
Country [1] 307349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306955 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 306955 0
Ethics committee country [1] 306955 0
Australia
Date submitted for ethics approval [1] 306955 0
20/07/2020
Approval date [1] 306955 0
14/08/2020
Ethics approval number [1] 306955 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105574 0
Prof David O'Neal
Address 105574 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 105574 0
Australia
Phone 105574 0
+61 3 9288 2012
Fax 105574 0
Email 105574 0
dno@unimelb.edu.au
Contact person for public queries
Name 105575 0
Dale Morrison
Address 105575 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 105575 0
Australia
Phone 105575 0
+61 413137853
Fax 105575 0
Email 105575 0
dale.morrison@unimelb.edu.au
Contact person for scientific queries
Name 105576 0
Dale Morrison
Address 105576 0
St Vincent's Hospital, 35 Victoria Pde, Fitzroy 3065 VIC
Country 105576 0
Australia
Phone 105576 0
+61 413137853
Fax 105576 0
Email 105576 0
dale.morrison@unimelb.edu.au

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.