Continuous Glucose Monitoring

Transcription

1 Continuous Glucose Monitoring Sensor Augmented Insulin Pump Therapy (SAIPT) & Ipro2 Continuous Glucose Monitoring: Programme Evaluation September 2017 Authors: Emma Mackenzie, Diabetes Service Co-ordinator. Iain Trayner, Technology Enabled Care Project Manager Clinical Lead: Jane Macaulay, Lead Diabetes Specialist Nurse

2 Contents Diabetes: A Changing Landscape 3 Introduction 4 Funding 5 The Technology 5 Methodology 7 Ipro 2: Outputs and Impact o Treatment 9 o Equity of Service 9 o Long Term Risk 10 o Clinical Experience 11 SAIPT: Outputs and Impact o Patient Safety 12 o Self Management 13 o Patient Experience 13 o Long Term Risk 14 o Service Redesign 15 o Impact on Primary Care 15 o Cost Benefit Realisation 16 o Challenges 17 Conclusion 18 2

3 Diabetes: A Changing Landscape According to current statistics, Diabetes affects one in twenty-five people in Scotland. That's over 228,000 people. Meanwhile, this figure could be as high as 250,000 as it is estimated that 20,000 people in Scotland remain undiagnosed. 1 Figures released this year by the Scottish Government estimate that the number of people with Diabetes in Scotland will rise by 110% in the next 15 years, with an incremental annual increase of 8%. 2 This will mean a huge increase in demand for services and these figures also highlight the need for a radical approach to both the treatment and ongoing management of people with Diabetes. About 10% of people with Diabetes have Type 1. Currently in the Western Isles there are approximately 1500 people with Diabetes and 150 of these have Type 1. A National Service Model for Home and Mobile Health Monitoring, Scottish Centre for Telehealth and Telecare, November 2016 Type 1 Diabetes Is an autoimmune condition where the body attacks and destroys insulin producing cells, meaning no insulin is produced. This causes glucose to rise quickly in the blood. Nobody knows exactly why this happens but science tells us it has nothing to do with diet or lifestyle. 3 The evidence that sustained near-normoglycaemia substantially reduces the risk of longterm complications in adults with type 1 diabetes is unequivocal 4. Impaired awareness of hypoglycaemia and severe hypoglycaemia creates barriers to many aspects of daily living, and can cause enormous stress for family and friends 5. 1 Diabetes in Scotland 2 A National Service Model for Home and Mobile Health Monitoring, Scottish Centre for Telehealth and Telecare, November 2016, licensed under the Open Government Licence

4 Introduction Sensor Augmented Insulin Pump Therapy (SAIPT) has been available to individuals in Scotland for several years, however this has generally been at their own expense or, in some cases, funded through the NHS on an individual basis. SAIPT combines the benefits of an insulin pump with those of a continuous glucose monitoring sensor (Ipro2). The sensor is connected wirelessly to the insulin pump, however, it can also be used as an autonomous device to record the data from people without an insulin pump (Also known as CGM). This means that people with Type 1 or Type 2 Diabetes who are suffering from hyperglycaemic or hypoglycaemic events with an unknown cause can be investigated accurately and remotely. The Western Isles form an archipelago of 9 inhabited islands approximately 50 miles off the Scottish Mainland, with a total population of 27,000. The Diabetes Team deliver a nurse led service (supported by an obligate network with Greater Glasgow & Clyde Health Board) to all 9 of these islands. This often requires frequent travel for both nurses and patients. As part of the nationally funded Technology Enabled Care Programme and in conjunction with the local ehealth Programme Board, NHS Western Isles Diabetes Team were able to provide both stand alone Ipro2 CGM devices and SAIPT (for existing insulin pumps) to people living in these remote islands. The Ipro2 CGM programme commenced in November 2015 with the follow on SAIPT Pilot launching in Jan 2017 after NICE Guidance published in February 2016 recommended the use of Sensor-augmented insulin pump therapy (SAIPT). As a result and, for the first time in Scotland, a full cohort of 8 people with Type 1 Diabetes and a compatible Insulin Pump (Minimed 640G) received SAIPT followed up by a local clinical evaluation. In conjunction with the use of Ipro2 for a cohort of patients selected using specific criteria. The Ipro2 sensor 4

5 use within the NHS is undocumented and the local team are anecdotally unaware of other boards using this technology. Traditional finger prick testing only provides a snap shot of a person s glycaemic profile, whereas the Ipro2 sensor provides a continuous picture. The evidence shows that this can facilitate a more streamlined pathway to treatment and follow up. For people without an insulin pump, the sensor can also be used to verify that any initiation, or changes to, medication has been effective without the need to wait for the standard 3 monthly HbA1c tests. This local evaluation report will demonstrate how the use of assistive technologies enables service providers to achieve measurable improvements in patient safety, a significant reduction in long term risk and capacity generation within Primary Care. Funding At the time of project conception and initiation there was no central provision for SAIPT or CGM funding. The team sourced funding for the equipment from the local Technology Enabled Care Programme (TEC) currently funded by the Scottish Government. Match funding was also provided by the local ehealth Programme Board and Diabetes Managed Clinical Network. The Technology SAIPT is an integrated system that combines an insulin pump, a continuous glucose monitor and a transmitter to send the continuous glucose readings wirelessly to the pump. The sensor continuously measures interstitial glucose levels via a small monofilament wire inserted into the skin to give readings, trends and warnings against pre-set limits. The Mini med insulin pump system also has the additional benefit of a suspend delivery of insulin feature for up to two hours; thus stopping over 80% of hypoglycaemic events and alleviating the constant worry that impending hypoglycaemia presents. When the data from the Ipro2 sensor is sent to the insulin pump, the Minimed system can detect not only falling blood glucose levels but the speed at which this is occurring. The pump is equipped with the ability to suspend insulin 5

6 supply before a pre determined figure if the trajectory of Blood Glucose levels suggests a steady decline. If the levels fall rapidly the pump will switch off the supply of insulin to the patient for up to 2 hours. Each individual registers their new sensor device with Medtronic and opens a Care link personal account. This enables data to be uploaded and viewed by the clinician remotely. When used as an autonomous device (not connected to an insulin pump) to measure continuous glucose levels this can be aligned with patient feedback on diet, medication, and daily activities This gives the clinician a unique insight into all the variables that could impact on blood glucose control. 6

7 Sensor Augmented Insulin Pump Therapy (SAIPT) & Ipro2 Continuous Methodology The team developed acceptance criteria for Ipro2 CGM sensor investigation to make sure that the device was used for patients with the most appropriate needs. Each participant had to: have experienced disabling hypoglycaemia and hyperglycaemia in the last 18 months are suspected of having undetected nocturnal hypoglycaemia +/- live in a remote rural setting +/- suffer from dementia +/- learning difficulties +/- neurological problems e.g. Parkinson s The team did not define acceptance criteria for SAIPT as the Cohort were already existing Insulin Pump (CSII) recipients. Twenty percent of the SAIPT cohort often experienced difficulty in resuming normal blood glucose levels quickly using routine treatment for hypoglycaemia. Many of our participants were living in remote and rural communities, with some working in the fishing or crofting sectors (maximum journey time to the nearest hospital was 1hr 16mins) The Diabetes Team collected both qualitative and quantitative for both CGM programmes by analysing the data uploaded to the Medtronic Carelink system, SCI Diabetes data and clinician comments. The team also received excellent data from participant feedback questionnaires. Quantitative Data parameters for Ipro2: This focussed on the number of technology assisted changes that optimised their diabetes treatment (as a direct result of previously unknown blood glucose readings). 7

8 Qualitative Data parameters for Ipro2: Parameters consisted of feedback from the local DSN team on the effectiveness of the Ipro2 device to aid decision making and remote monitoring. Quantitative Data parameters for SAIPT: the number of occasions the sensor predicted and intervened by suspending the supply of insulin prior to a hypoglycaemic event ( this range is pre determined by clinician and patient ) the number of occasions the sensor suspends due to a rapid decline in blood glucose levels From the total number of suspensions recorded how many were during the hours of 12 midnight to 6am Qualitative Data parameters for SAIPT: Each month, the participants were asked two questions which allowed them to feedback their experience of the CGM sensor: Have you made changes to your insulin pump as a result of the CGM data? Have the clinicians made any changes to your insulin pump as a result of the CGM data? 8

9 Treatment Outputs and Impact Ipro 2 (sensor only) In total 17 patients were fitted with Ipro2 sensors. Of these, 76% required changes to treatment in order to normalise their blood sugar levels and stabilise their hyper or hypoglycaemia. The continuous monitoring data enabled the clinical team to optimise the treatment regime, without this level of enhanced analysis it is very likely that there would have been a need for 3 rd party intervention. In some cases this may have resulted in a hospital admission Ipro 2 numbers Total changes to treatment Total non treatment changes Total of pts resensored Total ptsmoved to CSII/SAIPT Data source: SCI Diabetes The benefits observed apply to both hyper and hypoglycaemia. These focus mainly around improved accuracy of clinical decision making and a streamlined assessment process. The use of Ipro2 also expedited the journey of 2 patients who were subsequently transferred to the SAIPT programme. Equity of Service With the availability of a complete glycaemic profile, clinical decision making can be carried out remotely without the need for the patient to travel between islands to attend the Diabetes Specialist clinic. The diabetes specialist nurse is based in the main population centre of Stornoway which makes equity of service difficult to achieve. Using Ipro2 means that the local Link nurse is able to initiate changes to treatment with clinical supervision from the Specialist nurse or Diabetologist based on the data from the device. 9

10 The map below shows the geographic locality of those people who received Ipro2 CGM (sensor only) investigations. Travel between these locations can be difficult, time consuming and sometimes impossible due to inclement weather as travel between islands is either by ferry or air. Without this technology it is impossible to obtain this level of accuracy to aid with clinical decision making. Long Term Risk All the participants had their HbA1c levels checked pre Ipro2 and 6 months post. The patients HbA1C reduced on average by 5mmol over the course of the 6 months. This reduction equates to a 10% decrease in the risk of future complications to eyes, feet and kidneys, potentially avoiding known long term costly interventions such as dialysis, amputation and sight loss Average HbA1C Pre IPRO2 Average HbA1C post IPRO2 10

11 Clinical Experience The Diabetes team were asked every month for feedback on their use of Ipro2. The purpose of this was to collate the evidence to determine if their clinical practice had been impacted by Ipro2. Key statements from this feedback are displayed in the following image using their own words. 11

12 Patient Safety Outputs and Impacts: SAIPT Suspension data uploaded to the Medtronic Carelink system was analysed from Jan 2017 to August Over the course of the 8 month pilot the SAIPT device carried out 2353 suspensions of insulin delivery via the pump as a result of the device s ability to predict a hypoglycaemic event. Of the 2353 suspensions: 339 of these were during the hours of 12pm midnight and 6 am. This is usually when a patient is sleeping and unable to recognise and treat a hypo. Furthermore of the 2353 there were 15 suspension events where the pump was suspended due to a rapid unpredictable hypoglycaemic event thereby averting the need for 3 rd party intervention Pump suspensions before low Pump suspension between the hours of 12pm & 6am Pump suspension on low 0 1 Data source: Medtronic Carelink System 12

13 Self Management Patients reported, on a monthly basis, the benefits of having visual access to a 24/7 picture of their Blood Glucose levels. The pump screen depicts this with directional arrows and the number of arrows e.g. rapid decline in blood glucose levels would be three downward arrows. The graph below demonstrates the number of automatic suspensions in month 2 compared to month 8 of the pilot. There was a 53% reduction in suspensions over the 6 month period, this shows that over time participants were able to self manage and make adjustments in their own home without the need to visit clinic or contact the specialist nursing team. Suspension Data Month 2 Month 8 Suspensions Patient Experience 2 of the participants were asked to take part in a short film showcasing their CGM journey which is available here: In addition, the participants were asked every month for feedback on their CGM journey with a final questionnaire completed in September The purpose of this was to collate evidence on how their lives have been impacted by SAIPT and to give them an active role in the evaluation. Key statements from this feedback are displayed in the following image using their own words. 13

14 Long Term Risk All the SAIPT participants had their HbA1c levels checked pre SAIPT and 6 months post. The patients HbA1C reduced on average by 5mmoll over the course of the 6 months, this is predicted to be 10mmoll over the course of a 12 month period. This figure of predicted improvements would provide a 20% decrease in the risk of future complications to eyes, feet and kidneys thereby avoiding known long term risks such as dialysis, amputation and sight loss. The average cost of dialysis is 30,800 per patient per year, 3% of the NHS budget is spent on kidney failure services across the UK (National Kidney Federation UK) In the UK, 73 lower limb amputations are undertaken each week on diabetic patients, while, annually, 1,280 people become blind due to diabetes-related complications (Diabetes UK; UK Parliament 2010) 14

15 Foot problems in people with diabetes have a significant financial impact on the NHS. A report published in 2012 by NHS Diabetes estimated that around 650 million (or 1 in every 150 the NHS spends) is spent on foot ulcers or amputations each year. (NICE) Service Redesign All contacts are routinely recorded in SCI Diabetes by the Diabetes Specialist Nurses. This results in a comprehensive history of appointments, phone calls, s and letters. Analysis of this data shows a significant reduction in both direct and indirect contacts pre CGM in 2016 and post CGM in The charts illustrate the reduction in clinical contact with the pilot group DSN contact 2016 pre CGM DSN contact 2017 post CGM 0 Face to Face contacts phone calls letter s Data source: SCI Diabetes This cohort of 8 patients no longer requires the input of the visiting Consultant Diabetologist as a direct result of the continuing improvements in their blood glucose levels. This has reduced the waiting list by 17%. Impact on Primary Care The local clinical opinion is that due to the cumulative effect of improved glycaemic control and better self management there has been a dramatic reduction in the number of GP appointments coded as T1DM for the cohort post CGM. Although not a direct comparison in terms of time, 15 months pre CGM compared to 8 months post CGM there has been a 96% decrease in GP appointments for this cohort. 15

16 60 Number of GP appointments pre CGM Post CGM Data source: EMIS, collated by the NHS Western Isles Health Intelligence team Cost Benefit Realisation Analysis of patient activity pre and post CGM in terms of hospital admissions and GP appointments is as follows: Pre CGM admissions costs Totals HDU beds 3@ General Hospital bed 3@ A&E visit 2@ GP consultations Total 8729 Post CGM admissions costs HDU beds 0 0 General Hospital bed 0 0 A&E visit 0 0 GP consultations 5 45 Total 225 Although not a direct comparison in terms of time scales before and after CGM initiation it is accepted that there are significant cost savings associated with SAIPT. GP appointment costs have been estimated from on line research with admission costs obtained from the finance dept at NHS Western Isles. Benefit realisation needs to be viewed holistically as there are many contributing factors that can lead to indirect financial savings. A good example of this would be one of the participants who, after 2 difficult births, experienced a much improved patient journey after SAIPT initiation. 16

17 Case Study: Participant H Outline of the case study of participant H, a working mum, with Type 1 Diabetes, who was pregnant with her 3 rd child. The data from the SAIPT device had a direct impact on the management of her blood glucose levels and enabled both local clinicians in the Western Isles and the consultant diabetologist (as part of our obligate network with GGC) to manage her condition remotely with greater insight than ever before. The patient s previous pregnancies were complex due to poor glycaemic control and required hospitalisation post partum for both mum and baby. Both deliveries resulted in an extended stay in the specialist neo natal unit. The NHS Western Isles Finance dept have estimated the total cost to be in the region of 25,422 for both pregnancies. The SAIPT data was used to assist the consultant in the lead up to and during the birthing process. As a result of improved blood glucose control, both mum and baby only required what is considered to be a normal length of stay in hospital with no specialist neo natal intervention required. The costs for this delivery are estimated at 2,556. Therefore, we can demonstrate an estimated indirect cost saving of 22,866. Challenges Both the team and the participants experienced a number of challenges during the pilot. These were mainly training related issues such as uploading the data incorrectly and some difficulties with sensor placement. It should be noted that the participants themselves worked with the supplier to overcome these challenges which again demonstrates an element of self management. There was 1 pump malfunction that required a replacement. It is estimated that the cumulative effect of these challenges resulted in a 20% loss of data. We also experienced issues with participants forgetting to upload their data. This was overcome by using the Florence Text messaging system to send monthly upload reminders. 17

18 Conclusion Ipro2 can be used for Type 1 or Type 2 diabetes and is a key enabler that can facilitate more accurate, faster clinical decision making with the potential to reduce the need for 3 rd party intervention. The integration of Ipro2 with the Minimed 640G insulin pump opens up the sphere of influence and, as the evidence shows, has a positive impact on many different points of care. Many people believe SAIPT to be a cost prohibitive intervention for people with Type 1 diabetes. The annual cost per service user is 3960 for NHSWI and the evidence suggests that the savings achieved through fewer admissions is, on its own, not enough to neutralize the cost of initiation. However, when compared to the benefits associated with a 20% reduction in long term complications there is a strong economic case for using SAIPT. If SAIPT can delay one person from requiring kidney dialysis by only one year then the impact on their quality of life and on those around them is very significant. In terms of health economics, there is a direct cost saving of 30,800. However this return on investment may only be realised over the longer term. This is strengthened even further with the ability to generate capacity in Primary Care which is currently a hot topic for GP practices across the UK. The availability of more appointments means that more patients can access these services. Fewer contacts with clinical staff across the spectrum can only have a positive effect and is in line with the current national and local objective to improve self management. This can help to sustain local services at a time when the prevalence of long term conditions is predicted to rise exponentially. The positive effect on people s lives cannot be under estimated. This evidence demonstrates the shift from intensive management to self management while at the same time improving the quality of the data that can be used to make remote clinical assessments and changes to treatment plans. The participants feel more in control of their diabetes, safer at night and more confident to live and work in some of the most remote places in the UK. 18

19 Technology has its challenges but these can be overcome and the lessons learned transferred to future service users. Over time these will be alleviated by cheaper pricing models from suppliers, better broadband access and a population who are increasingly turning to technology to help with their everyday lives, not just their health care. The evidence now exists that demonstrates the direct and indirect benefits of both Ipro2 and SAIPT across many aspects of a person s journey with their diabetes. There is also strong evidence to suggest that these benefits affect many different areas of service provision. In a time when primary care and specialist nursing services are under sustained pressure SAIPT can generate the extra capacity required to offset some of these pressures and allow resources to be used more effectively. Further to this the Diabetes Team are looking to utilise Attend Anywhere, an NHS video conferencing platform to enhance the service. Offering remote and lone health workers the ability to assist and provide healthcare advice with neither clinician or patient leaving home or work base. Using this type of assistive technology in innovative ways reduces the hidden cost of providing services in remote and rural areas where travel costs for both clinician and patient can be exorbitant. As a service provider we have the ability to offer healthcare in the home ensuring accessibility to all whilst relieving pressures on both Primary and Secondary health care services. 19