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Trial registered on ANZCTR


Registration number
ACTRN12616000413426
Ethics application status
Approved
Date submitted
11/03/2016
Date registered
31/03/2016
Date last updated
5/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the performance and user acceptance of a mobile real-time continuous glucose monitoring system in people with type 1 and type 2 diabetes treated with multiple daily injections of insulin.
Scientific title
An evaluation of the performance and user acceptance of a mobile real-time continuous glucose monitoring system in people with type 1 and type 2 diabetes treated with multiple daily injections of insulin.
Secondary ID [1] 288650 0
None
Universal Trial Number (UTN)
U1111-1180-1722
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 297829 0
Condition category
Condition code
Metabolic and Endocrine 298002 298002 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the performance and user acceptance of the mobile real-time continuous glucose monitoring (RT-CGM) system in people with type 1 and type 2 diabetes treated with multiple daily injections of insulin. The mobile RT-CGM system consists of an electrochemical redundant glucose sensor and transmitter linked to a mobile device displaying real-time glucose information. The glucose sensor is inserted subcutaneously in the abdominal region and measures glucose in the interstitial fluid via a glucose oxidase reaction.

Twenty people (10 with type 1 diabetes, and 10 with type 2 diabetes > 10 years duration) will be recruited for this 12 week randomised crossover study, comprising two sequential 6 weeks study stages (Intervention and Usual Care). The Intervention stage involves using the mobile RT-CGM system. During the Usual Care stage participants undergo their usual diabetes management (including multiple daily injections of insulin and finger prick glucose monitoring) and they will have masked CGM with a glucose sensor linked to a recorder during the final 10 days of the stage.

Participants will attend the clinical trial centre (CTC) for study visits at study beginning, 6 weeks, 12 weeks and either on day 32 or 74 depending on randomisation (total 4 visits). There will also be telephone visits to ascertain protocol compliance.

Clinical examinations, frequent sampling tests for venous glucose measurement, HbA1c and 1,5-anhydroglucitol levels will be performed at CTC visits. A user evaluation questionnaire will be completed by participants after the 6 week Intervention stage. Sensors will be inserted and removed at the CTC by the research team, and participants will be educated regarding changing sensors at home. Participants will also be instructed to take finger-prick blood glucose measurements via the study meter at least 4 times per day and to record activities, meals and symptomatic hypoglycaemic episodes in a diary.
Intervention code [1] 294066 0
Treatment: Devices
Comparator / control treatment
Usual diabetes management (including multiple daily injections of insulin and finger prick glucose monitoring recommended at least 4 times per day, pre-meals and 2 hours post-meals), plus masked CGM during final 10 days of the study stage.
Control group
Active

Outcomes
Primary outcome [1] 297521 0
The impact of 6 weeks of mobile RT-CGM system use on proportion of time in CGM target range (4-10 mmol/L).
Timepoint [1] 297521 0
Final 10 days of each study stage.
Secondary outcome [1] 321294 0
Qualitative data from a study-specific user evaluation questionnaire relating to user acceptance of the mobile RT-CGM system.
Timepoint [1] 321294 0
At conclusion of 6 weeks of mobile RT-CGM system use.
Secondary outcome [2] 321295 0
Mobile RT-CGM system reliability measured by proportion of time sensor glucose is displayed (on review of uploaded data stored on the mobile device).
Timepoint [2] 321295 0
During 6 weeks of Intervention stage.
Secondary outcome [3] 321299 0
Mobile RT-CGM system accuracy measured by sensor mean absolute relative difference (MARD) relative to reference blood glucose measurements (provided by glucose meter and Yellow Springs Instrument).
Timepoint [3] 321299 0
During 6 weeks Intervention stage with reference blood glucose measured at home (recommended at least 4 blood glucose measurements per day, pre-meals and 2 hours post-meals) and while in the CTC (as part of a frequent sampling test).
Secondary outcome [4] 321300 0
Glucose sensor reliability measured by proportion of time sensor glucose is displayed (on review of uploaded data stored on the glucose sensor transmitter).
Timepoint [4] 321300 0
During final 10 days of Usual Care stage.
Secondary outcome [5] 321302 0
Glucose sensor accuracy measured by sensor mean absolute relative difference (MARD) relative to reference blood glucose measurements (provided by glucose meter and Yellow Springs Instrument).
Timepoint [5] 321302 0
During final 10 days of Usual Care stage with reference blood glucose measured at home (recommended at least 4 blood glucose measurements per day, pre-meals and 2 hours post-meals) and while in the CTC (as part of a frequent sampling test).

Secondary outcome [6] 321303 0
The impact of 6 weeks of mobile RT-CGM system use on proportion of time in high CGM range (>10 mmol/L).
Timepoint [6] 321303 0
Final 10 days of each study stage.
Secondary outcome [7] 321304 0
The impact of 6 weeks of mobile RT-CGM system use on proportion of time in low CGM range (<4 mmol/L and <3.3 mmol/L).
Timepoint [7] 321304 0
Final 10 days of each study stage.
Secondary outcome [8] 321487 0
The impact of 6 weeks of mobile RT-CGM system use on the mean CGM glucose level.

Timepoint [8] 321487 0
Final 10 days of each study stage.
Secondary outcome [9] 321488 0
The impact of 6 weeks of mobile RT-CGM system use on number of episodes of symptomatic hypoglycaemia (confirmed at the time of symptoms by glucose meter reading).
Timepoint [9] 321488 0
During 6 weeks of each study stage any time hypoglycaemia symptoms occur.
Secondary outcome [10] 321490 0
The impact of 6 weeks of mobile RT-CGM system use on change in HbA1c (measured using HPLC on lysed red blood cells).
Timepoint [10] 321490 0
At the start and end of each study stage.
Secondary outcome [11] 321924 0
The impact of 6 weeks of mobile RT-CGM system use on change in 1,5-anhydroglucitol (measured using an enzymatic colourimetric assay).
Timepoint [11] 321924 0
At the start and end of each study stage.

Eligibility
Key inclusion criteria
Type 1 diabetes, or type 2 diabetes > 10yrs of duration
Treated with multiple daily injections of insulin
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

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)
Sealed opaque envelopes
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
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5359 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 12812 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 293008 0
Hospital
Name [1] 293008 0
St Vincent's Hospital, Melbourne
Address [1] 293008 0
41 Victoria Parade, Fitzroy, VIC, 3065
Country [1] 293008 0
Australia
Funding source category [2] 293047 0
Commercial sector/Industry
Name [2] 293047 0
Medtronic Diabetes
Address [2] 293047 0
18000 Devonshire Street Northridge, CA, 91325
Country [2] 293047 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Melbourne
Address
41 Victoria Parade, Fitzroy, 3065, VIC
Country
Australia
Secondary sponsor category [1] 291786 0
None
Name [1] 291786 0
Address [1] 291786 0
Country [1] 291786 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294519 0
St Vincents Hospital Melbourne
Ethics committee address [1] 294519 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 294519 0
Australia
Date submitted for ethics approval [1] 294519 0
Approval date [1] 294519 0
27/05/2015
Ethics approval number [1] 294519 0
HREC-D 068/15

Summary
Brief summary
Traditionally finger-prick blood measurements using a glucose meter have guided the dosing of insulin for people with diabetes. The investigational system in this study involves insertion of a fine sensing filament under the abdominal skin to measure glucose levels continuously. This glucose information is transmitted to a device which displays the glucose in real time to the wearer.

This study aims to evaluate the impact of the investigational system on overall glucose levels in people with diabetes treated with multiple daily injections of insulin. Other study aims include evaluation of the performance of the technology and the wearer experience.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63990 0
A/Prof David O'Neal
Address 63990 0
St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy, Victoria, 3065
Country 63990 0
Australia
Phone 63990 0
+61 3 92312211
Fax 63990 0
Email 63990 0
dno@unimelb.edu.au
Contact person for public queries
Name 63991 0
Dr Anneke Graf
Address 63991 0
St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy, Victoria, 3065
Country 63991 0
Australia
Phone 63991 0
+61 3 92312211
Fax 63991 0
Email 63991 0
Anneke.GRAF@svha.org.au
Contact person for scientific queries
Name 63992 0
Dr Anneke Graf
Address 63992 0
St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy, Victoria, 3065
Country 63992 0
Australia
Phone 63992 0
+61 3 92312211
Fax 63992 0
Email 63992 0
Anneke.GRAF@svha.org.au

No information has been provided regarding IPD availability
Summary results
No Results