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Trial registered on ANZCTR


Registration number
ACTRN12606000049572
Ethics application status
Approved
Date submitted
31/01/2006
Date registered
1/02/2006
Date last updated
1/02/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Does real-time patient analysis of continuous glucose monitor data improve glycaemic control in patients with Type 1 diabetes on insulin pump therapy?
Scientific title
Does real-time patient analysis of continuous glucose monitor data improve glycaemic control in patients with Type 1 diabetes on insulin pump therapy? A randomised controlled trial of the MiniMed Paradigm Real Time Insulin Pump and Continuous Glucose Monitoring System.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 1011 0
Condition category
Condition code
Metabolic and Endocrine 1087 1087 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

In recent years, continuous glucose monitoring systems have been developed. Most currently available continuous glucose monitors measure glucose with minimal invasiveness through continuous measurement of interstitial fluid. Results from earlier models/ systems are only available retrospectively (eg with MiniMed CGMS or CGMS Gold devices information is downloaded after a 72 hour monitoring period), however newer models (eg MiniMed Guardian RT; RT= real time) incorporate technology for real-time display of glucose readings directly to the patient. In addition, real-time CGMs include an arrow on the display panel that indicates an upward or downward trend in glucose levels, allowing patients to predict the likelihood of needing to make appropriate adjustments to their immediate management to avoid hypo- or hyperglycaemia.

The recent escalation in the use of insulin pump therapy worldwide has been accompanied by significant advances in device technology. The MMT 722 device is the first integrated insulin pump system with inbuilt real-time continuous glucose readings available worldwide. To date this device has received CE Mark approval for use in Europe (CE Marking 0459/0976) and Health Canada regulatory approval in Canada. An application for TGA approval for use in Australia has been submitted.

The MMT 722 provides two independent functions– the delivery of insulin using standard basal/bolus insulin pump protocols and display of real time glucose values, trends and graphs from a subcutaneous continuous glucose sensor. Sensor readings are transmitted by radiofrequency signal every 5 minutes and shown on the display panel of the pager-sized pump device. In addition, alarms can be set to alert the patient of impending excursion to the hypo- or hyperglycaemic ranges. It is anticipated that the availability of this new combined insulin pump and continuous real-time glucose monitor will enable patients to make informed therapeutic decisions which would ultimately translate into improved patient-driven glucose control by increasing the time spent in the normoglycaemic range.

Hypothesis:
That the integration of real-time continuous glucose monitor data with an insulin pump device helps individuals with Type 1 diabetes to achieve improved glycaemic control and quality of life.
Aim:
To assess the impact of the use of The MiniMed Paradigm Real-time Insulin Pump and Continuous Monitoring System (MMT 722) on glycaemic control and quality of life in adolescents and young people with Type 1 diabetes.
Methodology:
Randomised Control Trial conducted at five sites in Australia. Sites involved in the project are:
1. Royal Children’s Hospital, Victoria
2. Royal Melbourne Hospital, Victoria
3. St Vincent’s Hospital, Victoria
4. The Children’s Hospital at Westmead, New South Wales
5. Princess Margaret Hospital for Children, Western Australia
The total study duration will be 6 months, during which the actual device trial intervention period will last for three months.
Each site will recruit patients who will subsequently be randomised into two groups (1:1): an intervention group and a control group.

The ‘intervention’ group will wear and use the MMT 722 device for the duration of the trial intervention period (3 months), while the ‘control’ group will continue to use their own pre-trial insulin pump device (no new intervention). While patients in the ‘intervention’ group will have access to continuous glucose readings on the display monitor of their pump, they will be instructed to continue SMBG in their usual manner (ie at least 4 times / day; usually fasting / pre-meals). All real time glucose readings that may provoke potential treatment decisions should be confirmed by a concomitant SMBG reading. Patients in the control group will continue to perform regular (4/day, as above) SMBG levels / day and treatment decisions will be based on these readings in the usual manner.
The two main physical components of the MMT 722 device are the continuous glucose sensor and the insulin pump device. The insulin pump device will be worn continuously throughout the trial period by participants in the intervention group (in place of their usual insulin pump device). The sensor component is designed to be used on either a continuous or intermittent basis. As the purpose of this trial is to determine the impact of continuous real time glucose readings on patient-initiated therapeutic interventions, the intervention group will be required to wear the sensor for >70% of the 3 month intervention period.

This project is a pilot study of a new therapeutic device to assess its acceptability to patients and its potential impact on glycaemic control. To date therefore, no baseline data to derive power calculations are currently available. Our sample size of 40-50 patients in total has been empirically chosen and is subject to constraint by the limited availability of the MMT 722 devices in Australia. In total there will be between 20 and 25 patients in the intervention group (either four or five patients at each site) and an equal number in the control group at each site.

Measurement tools: 1) Glycaemic status pre- trial intervention period:
One week of Medtronic Minimed continuous glucose monitoring system (CGMS Gold) device data will be recorded on all subjects. This CGMS Gold device does not give real-time glucose readings but stores data for retrospective analysis. Results will only be available once the stored data is downloaded at the end of the study period. 2)Glycaemic status post- trial intervention period:
In the Intervention group, MMT 722 CGMS data from the final week of the 3 month period will be analysed (participants will be required to wear the sensor 100% of time during this week)
The Control group will have repeat Medtronic CGMS Gold recording over the final week of the 3 month period.
3)Quality of Life measures used will be validated tools for use in diabetes. (DQOL for adult participants; DQoLY for adolescents up to age 18). 4)HbA1C will be measured centrally at DCCT accredited lab (Austin Health, Victoria).
Intervention code [1] 877 0
None
Comparator / control treatment
‘Control’ group will continue to use their own pre-trial insulin pump device (no new intervention).
Control group
Active

Outcomes
Primary outcome [1] 1452 0
Percent time in the “normoglycaemic” range (4-10 mmol/l).
Timepoint [1] 1452 0
This outcome will be a comparison between data obtained at baseline and at the end of 3 months. At baseline, prior to randomisation, all participants will have one week of continuous glucose monitoring using the CGMS Gold device. At the end of the 3 month trial period, a further week of continuous glucose data will be obtained from all participants (using the stored data on the MMT 722 device for the ‘intervention’ group and a further week of CGMS Gold monitoring for the control group).
Secondary outcome [1] 2599 0
Percent time in the hyperglycaemic range (>10 mmol/l)
Timepoint [1] 2599 0
Measured at baseline (prior to 3 month intervention period) and at the end of 3 months.
Secondary outcome [2] 2598 0
Percent time in the hypoglycaemic range (<4 mmol/l)
Timepoint [2] 2598 0
Measured at baseline (prior to 3 month intervention period) and at the end of 3 months.
Secondary outcome [3] 2600 0
Glycaemic variation (Continuous overlaping net glycaemic action [CONGA])
Timepoint [3] 2600 0
Measured at baseline (prior to 3 month intervention period) and at the end of 3 months.
Secondary outcome [4] 2601 0
HbA1C (post-trial intervention period cf pre- trial intervention period)
Timepoint [4] 2601 0
Measured at baseline (prior to 3 month intervention period) and at the end of 3 months.
Secondary outcome [5] 2602 0
Quality of Life measure (post-trial intervention period cf pre- trial intervention period)
Timepoint [5] 2602 0
Measured at baseline (prior to 3 month intervention period) and at the end of 3 months.

Eligibility
Key inclusion criteria
Type 1 diabetes. Diabetes duration > 1 year. Already using an insulin pump with bolus wizard or bolus wizard equivalent (ie bolus dose calculator)English-speakingReliably performing at least 4 SMBG readings per dayWillingness to use MiniMed MMT 722 glucose sensor >70% of study 3 month time period HbA1C < 8.0% Access to computer/e-mail facilities.
Minimum age
13 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Co-existent medical or mental health problems that would interfere with a patient’s ability to use the MMT 722 (eg impaired vision or hearing).

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)
Randomisation will be carried out at each site using a sealed envelope system. These sealed envelopes will be forwarded to each site by a central investigator who will not be directly involved in the medical care of any participants in the study. Each envelope will contain the study group allocation. There will therefore be four ‘intervention’ and an equal number of ‘control’ envelopes/allocations per site. One sealed envelope will be randomly assigned to each participant following completion of enrolment to the study at each site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2006
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)

Funding & Sponsors
Funding source category [1] 1191 0
Commercial sector/Industry
Name [1] 1191 0
Medtronic Australasia
Country [1] 1191 0
Australia
Primary sponsor type
Hospital
Name
Each site is individually sponsoring the trial at that site. Royal Children's Hospital, Parkville, Vic 3052
Address
Country
Australia
Secondary sponsor category [1] 1050 0
Hospital
Name [1] 1050 0
St Vincent's Hospital Melbourne Vic
Address [1] 1050 0
Country [1] 1050 0
Australia
Secondary sponsor category [2] 1049 0
Hospital
Name [2] 1049 0
Royal Melbourne Hospital Vic
Address [2] 1049 0
Country [2] 1049 0
Australia
Secondary sponsor category [3] 1052 0
Hospital
Name [3] 1052 0
The Children's Hospital at Westmead, NSW
Address [3] 1052 0
Country [3] 1052 0
Australia
Secondary sponsor category [4] 1051 0
Hospital
Name [4] 1051 0
Princess Margaret Hospital Perth WA
Address [4] 1051 0
Country [4] 1051 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35586 0
Address 35586 0
Country 35586 0
Phone 35586 0
Fax 35586 0
Email 35586 0
Contact person for public queries
Name 10066 0
Dr Michele O'Connell
Address 10066 0
Department of Endocrinology and Diabetes
Royal Children's Hospital
Parkville VIC 3052
Country 10066 0
Australia
Phone 10066 0
+61 3 93455951
Fax 10066 0
+61 3 93477763
Email 10066 0
michele.oconnell@rch.org.au
Contact person for scientific queries
Name 994 0
Associate Professor Fergus Cameron
Address 994 0
Department of Endocrinology and Diabetes
Royal Children's Hospital
Parkville VIC 3052
Country 994 0
Australia
Phone 994 0
+61 3 93455951
Fax 994 0
+61 3 93477763
Email 994 0
fergus.cameron@rch.org.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIGlycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial2009https://doi.org/10.1007/s00125-009-1365-0
N.B. These documents automatically identified may not have been verified by the study sponsor.