None listed
Conditions
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.
Interventions
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 hou
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.
Sponsors
St Vincents Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
13 Years to 70 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed