Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001295134
Ethics application status
Approved
Date submitted
4/09/2019
Date registered
19/09/2019
Date last updated
19/09/2019
Date data sharing statement initially provided
19/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Seven Day Study of a Combined Insulin Cannula and Glucose Sensor Delivering Basal and Bolus Insulin in Persons with Type 1 Diabetes
Scientific title
Clinical trial of device to evaluate the accuracy of an experimental continuous glucose monitor (CGM) measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy.
Secondary ID [1] 299170 0
Nil known
Universal Trial Number (UTN)
U1111-1239-6137
Trial acronym
SLC (Sensor Line Combination)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 314256 0
Condition category
Condition code
Metabolic and Endocrine 312612 312612 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental combined insulin cannula and glucose sensor delivering basal and bolus insulin via insulin pump. A wearable device inserted subcutaneously (similar to current commercially available insulin lines and cannulas) which will be tested with the commercially available T:slim insulin pump.

This will involve a one week run in period where participants familiarise themselves with the T:slim pump in conjunction with current commercially available insulin lines and cannulas. This will be followed by seven days of wearing the experimental device with the T:slim pump. The experimental device will be inserted by a study nurse or doctor. Experimental device CGM data will be collected throughout the seven days. Mixed meal tests will be conducted on day 1 and day 7 of experimental device wear. These will involve the participants attending the study centre. They will be cannulated for frequent blood sampling. The mixed meal containing a large 100-120g carbohydrate component will be eaten and appropriate insulin bolus determined by the T:Slim bolus calculator administered. Settings in the T:Slim pump will be the same as their usual settings. Frequent blood sampling will assess BGL 15 minutely as well as samples taken for insulin assays for a period of 6hrs. Experimental device CGM accuracy will be compared with reference YSI BGL levels as well as commercially available Dexcom G5 CGM readings.
Intervention code [1] 315459 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321260 0
Experimental device CGM sensor accuracy as determined by mean absolute difference (MAD) between experimental device sensor readings and reference YSI venous whole blood glucose values <75mg/dL and mean absolute relative difference (MARD) for reference YSI venous whole blood glucose values >75mg/dL during mixed meal testing with frequent venous blood sampling.
Timepoint [1] 321260 0
1 day and 7 days post post commencement of intervention during mixed meal testing with blood collected every 15 minutes for 6hrs.
Secondary outcome [1] 374475 0
Unexplained glycaemic excursions requiring a cannula change. Indicated by SMBG confirmed hyperglycaemia BGL>13.9mmol/L not responding to correction insulin boluses suggesting experimental device cannula blockage or failure.
Timepoint [1] 374475 0
Throughout 7 day period post intervention commencement. Participants will be asked to assess SMBG BGL levels at least 4 times per day.
Secondary outcome [2] 374476 0
Mean scores on scales assessing subjective participant perceptions and discomfort. Assessed by Tolerability Questionnaire completed by participants.
Timepoint [2] 374476 0
Day 1 and day 7 post intervention commencement.
Secondary outcome [3] 374784 0
Objective changes reflecting skin reactions at site of experimental device insertion. Assessed by Draize Scale completed by research staff.
Timepoint [3] 374784 0
Day 1 and 7 post intervention commencement.

Eligibility
Key inclusion criteria
1. T1D, of at least 6 months duration.
2. Age 21-75
3. Insulin pump usage at the time of screening and for at least 3 months prior to screening.
4. HbA1c between 5.8 and 10%
5. Willingness and ability to follow all study procedures and to attend all clinic visits.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chronic kidney disease as defined by estimated-GFR < 45 ml/min
2. Inadequately-treated proliferative diabetic retinopathy
3. Inability to read pump or CGM display due to reduced visual acuity
4. Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
5. Cerebrovascular disease causing permanent physical or cognitive limitation
6. Chronic liver disease with synthetic deficiency (defined as serum albumin of <3.3 g/dl, or serum total bilirubin exceeding 2.5 mg/dl)
7. Any active foot ulcer
8. Known active infection such as HIV or hepatitis
9. Active malignancy, except for basal or squamous cell skin cancer
10. Anaemia defined by HCT at least 4 percentage points below lower limit of the reference range
11. History of cardiac arrhythmia (note: PVC’s numbering < 6 per minute are not exclusionary)
12. Dementia
13. Schizophrenia or other untreated mental illness
14. Chronic substance abuse
15. Seizure disorder
16. Major surgical operation within 30 days prior to screening
17. Bleeding disorder, or treatment with anticoagulants
18. Allergy to Lispro insulin
19. Allergy to acrylate-based skin adhesives
20. Use of an investigational drug or device in the last 30 days
21. Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods.
22. Diabetic ketoacidosis or major hypoglycemia within the last 6 months
23. Insulin resistance as defined by insulin requirement of more than 200 units per day
24. Use of glucose-lowering medications other than insulin
25. Need for uninterrupted treatment with acetaminophen
26. Any other physical or mental condition judged by the PI as being exclusionary.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2019
Actual
Date of last participant enrolment
Anticipated
29/02/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14710 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 27749 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 303711 0
Commercial sector/Industry
Name [1] 303711 0
Pacific Diabetes Technologies
Country [1] 303711 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade
Fitzroy, 3065
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 303822 0
None
Name [1] 303822 0
Address [1] 303822 0
Country [1] 303822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304238 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 304238 0
41 Victoria Parade
Fitzroy, 3065
Victoria, Australia
Ethics committee country [1] 304238 0
Australia
Date submitted for ethics approval [1] 304238 0
Approval date [1] 304238 0
27/06/2019
Ethics approval number [1] 304238 0
HREC 105/19

Summary
Brief summary
This study will evaluate the accuracy of an experimental CGM measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy. Glucose sensor accuracy will be evaluated over a 7 day period as well as infusion site patency and tolerability of the experimental device. Participants will be changed to a study pump for the duration of the study. In addition to utilizing the study device in a free living state, all participants will also undergo two high carbohydrate mixed meal challenges to assess the performance and accuracy of the study device.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96238 0
Prof David O'Neal
Address 96238 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria, Australia
Country 96238 0
Australia
Phone 96238 0
+61 425731665
Fax 96238 0
Email 96238 0
[email protected]
Contact person for public queries
Name 96239 0
Ms Catriona Sims
Address 96239 0
The University of Melbourne, Department of Medicine
41 Victoria Parade
Fitzroy 3065
Victoria, Australia
Country 96239 0
Australia
Phone 96239 0
+61 417482010
Fax 96239 0
Email 96239 0
[email protected]
Contact person for scientific queries
Name 96240 0
Prof David O'Neal
Address 96240 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy 3065
Victoria, Australia
Country 96240 0
Australia
Phone 96240 0
+61 425731665
Fax 96240 0
Email 96240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only.
When will data be available (start and end dates)?
immediately following publications, no end date.
Available to whom?
case by case basis at the discretion of the primary sponsor.
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by principal investigator.

email: [email protected]


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.