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Trial registered on ANZCTR


Registration number
ACTRN12616000005459
Ethics application status
Approved
Date submitted
9/06/2015
Date registered
12/01/2016
Date last updated
24/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of user acceptance and performance of a mobile real-time continuous glucose monitoring system in people with type 1 and type 2 diabetes.
Scientific title
An evaluation of user acceptance and performance of a mobile real-time continuous glucose monitoring system in people with type 1 diabetes (T1D) and with type 2 diabetes treated with multiple daily injections (MDI) of insulin.
Secondary ID [1] 286879 0
Nil
Universal Trial Number (UTN)
U1111-1171-0698
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes. 295283 0
Type 2 Diabetes treated with multiple daily injections of insulin. 295284 0
Condition category
Condition code
Metabolic and Endocrine 295535 295535 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate the user acceptance of a real time continuous glucose monitoring (RT-CGM) system in people with T1D and T2D treated with MDI of insulin. This study also intends to evaluate the performance of the system and the the impact it has on glycaemia.

The RT-CGM system consists of a glucose sensor and transmitter and a linked study iPod displaying glucose information. The glucose sensor is inserted subcutaneously, in the abdomen region, and measures glucose in the interstitial fluid (IF) through a glucose oxidase reaction.

This study is a randomized crossover study involving 20 participants (10 with T1D and 10 with T2D using MDI of insulin). Participants will undertake one week of unmasked RT-CGM system (where there will be able to see their CGM information) linked to a study iPod , and one week of masked RT-CGM system (where they will not be able to see their CGM information) linked to a glucose senor recorder (GSR), in random order.

Following baseline clinical assessment, researchers will provide participants with education about study devices. Initial venous blood sampling for HbA1c and 1,5 AG will be taken. 1 hour following sensor insertion, participants will undergo frequent venous blood samples (FST) to measure plasma glucose at 20 minute intervals for a duration of 3 hours. . For the 2 week study period participants will be instructed to undertake reference capillary blood glucose measurements (a minimum of 4 times a day) and to wear the RT-CGM system continuously.

For the study duration participants will be instructed to keep a diary documenting activity, diet, capillary glucose reading, insulin, and symptomatic hypoglycaemia episodes.

Participants will attend a study visit on Day 8. Participants assigned to the unmasked RT-CGM arm will complete a user evaluation questionnaire.

A standard meal will be provided to both groups and venous bloods for glucose will be collected from the start of the meal at 20 minute intervals for a duration of 5 hours. Two hours post-meal a second sensor will be inserted to allow for crossover of the study, where the sensor will be linked to the alternative GSR or iPod. The sensor inserted on Day 1 will be removed and collected for review of the data prior to the participants departure.

On Day 15 participants will attend their final study visit. Participants assigned to the unmasked RT-CGM for the second half of the study will complete a user evaluation questionnaire. An intravenous cannula will be inserted to the cubital fossa and venous blood for HbA1c and 1,5 anhydroglucitol (1,5 AG) will be taken. Participants will then be provided a meal and have venous blood collected at this time at 20 minute intervals over the following 3 hours for plasma glucose measurements.
Intervention code [1] 292059 0
Treatment: Devices
Comparator / control treatment
masked RT-CGM as a comparator.
Control group
Active

Outcomes
Primary outcome [1] 295268 0
Participant acceptance regarding comfort and utility of the RT-CGM system.
Timepoint [1] 295268 0
Assessed via a questionnaire designed specifically for the study after 6 weeks of use.
Secondary outcome [1] 315221 0
Performance of the RT-CGM system measured by proportion of time
the glucose sensor is displayed and the mean absolute relative
difference relative to YSI and study meter glucose.
Timepoint [1] 315221 0
Monitored continuously over the 6 weeks of wear
Secondary outcome [2] 315222 0
Performance of the RT-CGM system measured by proportion of time the glucose sensor is displayed and the mean absolute relative difference relative to YSI and study meter glucose.
Timepoint [2] 315222 0
Monitored continuously during the 6 weeks of wear
Secondary outcome [3] 315223 0
Comparison of percentage time in CGM target range (4-8mmol/L) in RT-CGM system versus ""usual care"" study group.
Timepoint [3] 315223 0
Monitored continuously over the study.
Secondary outcome [4] 315224 0
Comparison of percentage time above target CGM range (>10mmol/L) in in RT-CGM system versus ""usual care"" study group.
Timepoint [4] 315224 0
Monitored continuously over the study.
Secondary outcome [5] 315225 0
Comparison of percentage time below target CGM range (<4mmol/L) in the RT-CGM system versus ""usual care"" study group.
Timepoint [5] 315225 0
Monitored continuously over the study.
Secondary outcome [6] 315226 0
Change in overall glycaemia as measured by laboratory assays for 1,5 AG.
Timepoint [6] 315226 0
Venous blood samples obtained on Day 1, 32, 42, 54, 64

Eligibility
Key inclusion criteria
-T1D, or T2D of >10 years duration treated with MDI of insulin
-Participant willing to comply with study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Pregnant or planned pregnancy during the study period
-Life-threatening illness
-Major psychiatric illness

Study design
Purpose of the study
Prevention
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical comparison for this study will be performed using a two tailed paired t-test (p<0.05). This study is a hypothesis generating study, therefore no statistical assumptions were used when deciding the number of participants needed to achieve study objectives. It will be used to inform larger studies incorporating clinical interventions.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3897 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 9790 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 291439 0
Commercial sector/Industry
Name [1] 291439 0
Medtronic Diabetes
Country [1] 291439 0
United States of America
Primary sponsor type
Hospital
Name
St Vincents hospital Melbourne
Address
41 Victoria Parade
Fitzroy 3065 VIC
Country
Australia
Secondary sponsor category [1] 290113 0
None
Name [1] 290113 0
Address [1] 290113 0
Country [1] 290113 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292990 0
St Vincents Hospital Melbourne
Ethics committee address [1] 292990 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 292990 0
Australia
Date submitted for ethics approval [1] 292990 0
Approval date [1] 292990 0
07/05/2015
Ethics approval number [1] 292990 0

Summary
Brief summary
Until recently, insulin administration has been based upon finger-prick measurements of capillary glucose readings. RT-CGM involves using a subcutaneous sensor to measure interstitial fluid glucose levels continuously and provides the patient with the glucose level in real-time, as well as the rate and direction of change in the glucose. While there is an increasing body of evidence indicating that RT-CGM in combination with an insulin pump results in an improvement in glycaemia and reduces hypoglycaemia, compared with self monitoring of blood glucose (SMBG) and MDI in people with T1D, data is limited regarding the use of RT-CGM in conjunction with MDI. The study aims to evaluate the user acceptance of the RT-CGM device in patients with T1D, and T2D on MDI, as well as to evaluate its' impact on glycaemic control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57942 0
A/Prof David O'Neal
Address 57942 0
St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy Victoria 3065
Country 57942 0
Australia
Phone 57942 0
+61 3 92312211
Fax 57942 0
Email 57942 0
[email protected]
Contact person for public queries
Name 57943 0
Sybil McAuley
Address 57943 0
St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy Victoria 3065
Country 57943 0
Australia
Phone 57943 0
+61 3 92312211
Fax 57943 0
Email 57943 0
[email protected]
Contact person for scientific queries
Name 57944 0
Sybil McAuley
Address 57944 0
St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy Victoria 3065
Country 57944 0
Australia
Phone 57944 0
+61 3 92312211
Fax 57944 0
Email 57944 0
[email protected]

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