None listed
Conditions
Brief summary
Our aim is to test the effect of a new wearable device (a continuous glucose monitor) on the achievement of evidence-based targets for overall glucose levels (glycemic targets). The general way of measuring glycaemic targes is to measure HbA1C in the blood, which gives an average of the glucose levels over the last 3 mths. Based on this measure about half of people with T2D in the community are not in the glycemic target of 53 mmol/mol.. We think knowing more about the day-to-day variation in glucose levels may be important, because that sort of information might help GP and patient to make more personalised and rational changes in treatment (including lifestyle changes and medicines). Our research question are: 1. Does the judicious use of intermittent retrospective continuous glucose monitoring (r-CGM) in primary care improve glycaemic control as measured by HbA1c? 2. Is intermittent r-CGM cost-effective? This is an individually randomised controlled trial set in General Practices in Victoria. Up to 60 practices and up to 300 patients will participate. Eligible patients are people with T2D who are out of glycaemic target despite moderately intensive therapy. People will be asked to complete a survey and have a blood test at the beginning and at 12 months. Patients randomised to the intervention group are asked to wear the r-CGM device every three months for a period of 2 weeks then to meet their GP to discuss it. Patients in the control group just continue to have usual diabetes care.
Interventions
GP-OSMOTIC is a 2-arm individually randomised controlled trial (RCT) in general practice comparing collaborative retrospective Continuous Glucose Monitoring (r-CGM) to usual care in people with T2D on maximum non-insulin hypoglycaemic therapy and/or insulin whose HbA1c is out-of-target.
All participating General Practitioners (GPs) and Practice Nurses (PNs) will take part in a 2 hour training session, either on site at the practice or via an online video recording of the training. The training
GP-OSMOTIC is a 2-arm individually randomised controlled trial (RCT) in general practice comparing collaborative retrospective Continuous Glucose Monitoring (r-CGM) to usual care in people with T2D on maximum non-insulin hypoglycaemic therapy and/or insulin whose HbA1c is out-of-target. All participating General Practitioners (GPs) and Practice Nurses (PNs) will take part in a 2 hour training session, either on site at the practice or via an online video recording of the training. The training will be provided by a GP with a special interest in diabetes with minimum 5 years’ experience, a Registered Nurse-Credentialed Diabetes Educator with minimum 5 years’ experience and a health psychologist with expertise in diabetes self management and education. The training will involve a presentation about the rCGM device being used in the study (Abbott Libre Pro (c)), how to use the device and interpret the output, and will include a case-based discussion with role-playing vignettes )provided as short video clips) modelling a collaborative approach to consulting with patients and using the rCGM output in discussing treatment intensification. Patients randomised to the intervention will attend an individual one-to-one, face-to-face Education Session of 60 minutes with the study Registered Nurse-Credentialed Diabetes Educator (RN-CDE). This will be held on-site at the patient's General Practice. This session will include instruction on how to wear the rCGM device being used (Abbott Libre Pro (c)) and how to interpret the glucose reports from the device in understanding diabetes self-management and in discussing treatment intensification with their GP. Brief supportive information about the device and about diabetes self-management (as commonly provided in diabetes education sessions) will be provided to patients. Intervention patients will be asked to wear the rCGM device for a period of 2 weeks every 3 months ie at baseline, 3,6,9 and 12 months, as well as having an HbA1c at those times, and to consult with their GP and discuss the rCGM output glucose reports. This 3 monthly interval is in keeping with clinical practice guidelines about step wise regular consideration of treatment intensification. The rCGM device will be applied at those 3 monthly intervals by the GP clinic staff (ie the GP or Practice Nurse who have attended the health professional training). Patients and practices will be sent reminders to undertake this 3 monthly monitoring. The training session for both health professionals and patients will cover collaborative interpretation of rCGM data in guiding treatment intensification. The aim of the training is to ensure that health professionals and patients have the knowledge, confidence and skills to work collaboratively to: 1. support the use of r-CGM; 2. interpret glucose patterns with a focus on *fasting & postprandial levels, *detecting hyper- and hypoglycaemia, and *understanding glycaemic variability; 3. discuss behaviour change & 4. discuss treatment intensification, drawing on current evidence-based clinical guidelines. Referral or consultation with an endocrinologist, CDE or any other appropriate health professional will be management options for GPs managing study patients
Sponsors
John Furler
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Eligible practices / practitioners: General Practices in Victoria 2. Eligible patients: aged 18-80 years, Type 2 diabetes duration of >1 year and most recent HbA1c (in the previous 1 month) >7mmol/mol (0.5%) above their individualised target (based on age, duration of diabetes and complications) who are on at least two non-insulin hypoglycaemic therapy and/or insulin (therapy stable for the last 4 months).
Exclusion criteria
Debilitating medical condition (e.g. unstable CVD, severe mental illness, end-stage cancer), an eGFR<30 ml/min/1.73m2; proliferative retinopathy, pregnancy, lactating or planning pregnancy, unable to speak English/give informed consent, unwilling to use r-CGM or follow study protocol, allergy to adhesive tape, diagnosis of T2D within the past 12 months any condition that makes monitoring diabetes using HbA1c unreliable (e.g. haemoglobinopathy, iron deficiency anaemia).
Outcome results
None listed