Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000198426
Ethics application status
Approved
Date submitted
4/04/2007
Date registered
11/04/2007
Date last updated
7/04/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian Sensor-Augmented Pump Algorithm Study
Scientific title
Evaluation of an Algorithm to
Guide Patients with Type I Diabetes
Treated with Continuous Subcutaneous Insulin Infusion on How to Respond to
Real-Time Continuous Glucose Levels.
Universal Trial Number (UTN)
Trial acronym
ALG-OS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 1720 0
Glycaemic control. 1721 0
Oxidation 1722 0
Condition category
Condition code
Metabolic and Endocrine 1813 1813 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insulin pump therapy with real-time continuous glucose monitoring. Intervention-the provision of an algorithm to guide therapy.Control-No algorithm provided.

The algorithm is a guide advising patients with Type I diabetes managed with pump therapy on how to best respond to the information provided by continuous real-time glucose monitoring. In particular it will advise the patient on how to adjust their insulin dosing in response to glucose levels, glucose trend information, and twenty four hour profiles provided by the continuous monitoring device in both in the short term (reactively) and in the long term (proactively). The study is to be conducted in two 16 week phases. In phase one, those allocated the algorithm will be instructed in its principles which are to be applied throughout this phase of the study. During this period they are to wear the real-time continuous glucose monitoring device for at least 70% of the time. During the second 16 week phase of the study, those who had previously been allocated the algorithm will return to usual care ie insulin pump without real-time glucose monitoring. The patients will retain the principles of the algorithm to a varying extent. What is learned in the first phase of the study may provide a benefit with regard to glycaemic control that extends beyond the period of real-time monitoring and this hypothesis is to be tested in the second phase of the study. Those subjects randomised to the arm of the study where no algorithm has been provided in the first phase will receive the algorithm at the start of the second 16 week phase. Any shortcomings noted while the algorithm is being implemented during the first phase are to be addressed prior to the provision of the algorithm to those patients who were not randomised to the algorithm arm in phase one.

All patients regardless as to whether they are randomised to the algorithm or not will receive instructions on how to operate the insulin pump device and the real time monitor. An accredited pump trainer and diabetes nurse educator will be responsible for this aspect of the education of the patients who take part in the study. In particular instructions will be provided regarding operation of the menu and buttons of the pump, care of the transmitter, and insertion and care of the sensor. Medical follow up apart from the above and provision of the algorithm in those randomised to the relevant arm of the study will be as per routine care for all patients established on insulin pumps at each of the hospitals taking part in the study.

The total duration of the study is to be encompassed by a 2 week run-in phase, and the two phases each of 16 week duration making a total of 34 weeks.
Intervention code [1] 1613 0
Treatment: Devices
Comparator / control treatment
Control-No algorithm provided.
Control group
Active

Outcomes
Primary outcome [1] 2534 0
Time spent within the euglycaemic range.The primary outcome is to be determined by three continuous glucose monitoring studies each of six day duration
Timepoint [1] 2534 0
Following screening prior to randomisation, 16 weeks and 32 weeks.
Secondary outcome [1] 4381 0
Time spent within the hyperglycaemic range.
Timepoint [1] 4381 0
Baseline, 16 weeks and 32 weeks.
Secondary outcome [2] 4382 0
Time spent within the hypoglycaemic range.
Timepoint [2] 4382 0
Baseline, 16 weeks and 32 weeks.
Secondary outcome [3] 4383 0
Glycosylated Haemoglobin.
Timepoint [3] 4383 0
Baseline, 16 weeks and 32 weeks.
Secondary outcome [4] 4384 0
Glycaemic variability.
Timepoint [4] 4384 0
Baseline, 16 weeks and 32 weeks.
Secondary outcome [5] 4385 0
Quality of Life Score.
Timepoint [5] 4385 0
Baseline, 16 weeks and 32 weeks.

Eligibility
Key inclusion criteria
Type I diabetes (c-peptide negative)- English speaking. Established on pump therapy for at least 3 months and be proficient in the use of an insulin dose calculator. -Proficient at and committed to at least four fingerprick glucose measurements per day.-Willing to use MiniMed MMT 722 glucose sensor >70% of study time period.-Current HbA1c of <9.5% -All should have access to electronic communication ie email.
Minimum age
13 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Visual Impairment such that the patient is unable to see the screen or fill the reservoir of the CSII device, or read a glucometer display or administer insulin safely using a pen device.- Intellectual or language difficulties such that operation of a CGM or CSII device is precluded.-Significant renal impairment (eGFR <60 mL/min/1.73 m2 )-Eating Disorders.-Major Psychiatric Disorders.-Life threatening illness (eg myocardial infarct) within last three months.- Steroid therapy or the presence of disease states likely to require future steroid therapy.-Abnormal thyroid function.-A history of gastroparesis or delayed gastric emptying.-Untreated/ inadequately treated coeliac disease.-Pregnancy. For women of childbearing age appropriate contraceptive measures should be taken.- A documented history of insulin allergy/ antibodies.-Patients with haemoglobinopathies or patients requiring regular transfusions.

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)
Eligible subjects are to be selected from site databases and contacted by the investigators at each site. Allocation will involve contacting the holder of the allocation schedule who will be at central administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1965 0
Commercial sector/Industry
Name [1] 1965 0
Medtronic
Country [1] 1965 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital Melbourne
Address
University of Melbourne, Dept of Medicine, St Vincent's Hospital, Fitzroy 3065, Vic Australia.
Country
Australia
Secondary sponsor category [1] 1774 0
Hospital
Name [1] 1774 0
Royal Childrens Hospital Melbourne
Address [1] 1774 0
Flemington Rd, Parkville, Victoria, Australia
Country [1] 1774 0
Australia
Secondary sponsor category [2] 1775 0
Hospital
Name [2] 1775 0
Royal Melbourne Hospital
Address [2] 1775 0
Royal Parade, Parkville, Victoria, Australia
Country [2] 1775 0
Australia
Secondary sponsor category [3] 1776 0
Hospital
Name [3] 1776 0
Western General Hospital Melbourne
Address [3] 1776 0
Gordon st. Footscray, Victoria, Australia
Country [3] 1776 0
Australia
Secondary sponsor category [4] 1777 0
Hospital
Name [4] 1777 0
Monash Medical Centre Clayton
Address [4] 1777 0
Clayton rd Clayton, Victoria, Australia
Country [4] 1777 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3659 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 3659 0
Victoria Pde Fitzroy, Victoria,3065
Ethics committee country [1] 3659 0
Australia
Date submitted for ethics approval [1] 3659 0
Approval date [1] 3659 0
01/07/2007
Ethics approval number [1] 3659 0
Ethics committee name [2] 3660 0
Royal Melbourne Hospital
Ethics committee address [2] 3660 0
Ethics committee country [2] 3660 0
Australia
Date submitted for ethics approval [2] 3660 0
Approval date [2] 3660 0
Ethics approval number [2] 3660 0

Summary
Brief summary
In patients with Type 1 diabetes the body does not produce any insulin. Insulin is a hormone that the body (pancreas) produces. Insulin is essential for life; In a healthy body the pancreas produces insulin continuously all day to keep blood sugar in a healthy range to allow us to do all activities that do not require eating such as walking, talking, sleeping. In the event of eating the pancreas automatically produces an extra amount of Insulin on demand when food is consumed. Foods such as carbohydrates and starches are processed by the body into sugar in the bloodstream. The hormone Insulin stabilizes blood sugar to a healthy range so that there is not too much or too little sugar in the blood. In a diabetic maintaining this balance is difficult because the pancreas is not producing any insulin. As such external insulin must be administered. The results of a landmark study known as the Diabetes Control and Complications Trial (DCCT) demonstrated that strict blood sugar control reduced the development of complications in patients with Type I diabetes like strokes, kidney and eye disease. An ideal solution in these patients would be the replacement of insulin in a manner identical to that in the healthy state. At present the two main options for patients, both of which deliver insulin through injections, are multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII) via a mechanical device usually referred to as a “pump.”

CSII or the “pump” delivers insulin in a flexible and precisely controlled manner via a programmable pager sized device with an insulin reservoir. Insulin delivery rates can be varied according to the time of day, and reduced temporarily during periods of exercise. A patient-initiated dose of insulin can be delivered in a variety of profiles aimed to match the nature of the ingested meal.
Recently a combination real-time Continuous (blood) Glucose Monitoring/ CSII “pump” device has become available (Paradigm? Real-time system / MMT 722, Medtronic, Minimed, Northridge CA) and is the first such pump commercially available worldwide.
The ultimate aim in the management of patients with Type I diabetes is the attainment of stable blood glucose, as this strategy will prevent the development of complications. The above product is instrumental to this.
However, preliminary data suggests that the employment of real-time system “pump” in the absence of a patient education program may not result in an improvement in glycaemic control. An algorithm informing and educating the patient on how to deal with the information provided by this new technology will be analysed as part of this study. In addition a blood test known as Hba1c will also be performed. This blood test measures on average a patient’s blood glucose control over a three month span. Quality of Life Questionnaires will also be used to assess whether diabetes has impacted of every day life and activities.
Five sites across Melbourne have been selected to take part. The principle Investigators are at St Vincent’s Adults public Hospital. The other sites involved are: The Western General Hospital, Monash Medical Centre, The Royal Children’s Hospital and The Royal Melbourne Hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27547 0
Address 27547 0
Country 27547 0
Phone 27547 0
Fax 27547 0
Email 27547 0
Contact person for public queries
Name 10802 0
Dr David Norman O'Neal
Address 10802 0
Department of Medicine (St. Vincent’s Hospital)
Clinical Science Building
St Vincent’s Hospital
Cnr. Princes and Regent Streets
Fitzroy, Melbourne VIC 3065
Country 10802 0
Australia
Phone 10802 0
+ 61 3 9288 2574
Fax 10802 0
+61 3 9288 2581
Email 10802 0
[email protected]
Contact person for scientific queries
Name 1730 0
Dr David Norman O'Neal
Address 1730 0
Department of Medicine (St. Vincent’s Hospital)
Clinical Science Building
St Vincent’s Hospital
Cnr. Princes and Regent Streets
Fitzroy Melbourne VIC 3065
Country 1730 0
Australia
Phone 1730 0
+ 61 3 9288 2574
Fax 1730 0
+61 3 9288 2581
Email 1730 0
[email protected]

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 AIEvaluation of an Algorithm to Guide Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion on How to Respond to Real-Time Continuous Glucose Levels A randomized controlled trial2010https://doi.org/10.2337/dc09-1481
N.B. These documents automatically identified may not have been verified by the study sponsor.