Continuous Glucose Monitoring - TEC Scotland · 2019-08-29 · Glucose Monitoring: Programme Evaluation 9 Outputs and Impact Ipro 2 (sensor only) Treatment In total 17 patients were

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


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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


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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 long-term complications in adults with type 1 diabetes is unequivocal4. Impaired awareness of hypoglycaemia and severe hypoglycaemia creates barriers to many aspects of daily living, and can cause enormous stress for family and friends5 .

1 Diabetes in Scotland – www.Diabetes.co.uk 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 http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/non-commercial-government-licence.htm. 3 https://www.diabetes.org.uk/diabetes-the-basics 4 https://www.nice.org.uk/guidance/ng17/resources/type-1-diabetes-in-adults-diagnosis-and-management-1837276469701

5 https://www.nice.org.uk/guidance/ng17/resources/type-1-diabetes-in-adults-diagnosis-and-management-1837276469701

http://www.diabetes.co.uk/diabetes-scotland.html

http://www.nationalarchives.gov.uk/doc/non-commercial-government-licence/non-commercial-government-licence.htm

https://www.diabetes.org.uk/diabetes-the-basics

https://www.nice.org.uk/guidance/ng17/resources/type-1-diabetes-in-adults-diagnosis-and-management-1837276469701

https://www.nice.org.uk/guidance/ng17/resources/type-1-diabetes-in-adults-diagnosis-and-management-1837276469701


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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


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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


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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.


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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).


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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?”


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Outputs and Impact Ipro 2 (sensor only)

Treatment

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 3rd

party intervention. In some cases this may have resulted in a hospital

admission.

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.

0 1 2 3 4 5 6 7 8 9

10

Ipro 2 numbers

Total changes to treatment

Total non treatment changes

Total of pts re-

sensored

Total ptsmoved

to CSII/SAIPT

2016

2017


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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.

60 65 70 75 80 85 90 95

100

Average HbA1C Pre IPRO2

Average HbA1C post IPRO2


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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.


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Outputs and Impacts: SAIPT

Patient Safety

Suspension data uploaded to the Medtronic Carelink system was analysed

from Jan 2017 to August 2017.

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 3rd party intervention.

Data source: Medtronic Carelink System

0

500

1000

1500

2000

2500

1

2353

339 15

Pump suspensions before low

Pump suspension between the hours of 12pm & 6am

Pump suspension on low


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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.

Patient Experience

2 of the participants were asked to take part in a short film showcasing their

CGM journey which is available here: https://vimeo.com/225977891

In addition, the participants were asked every month for feedback on their

CGM journey with a final questionnaire completed in September 2017. 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.

0

100

200

300

400

500

600

700

Month 2 Month 8

Suspension Data

Suspensions

https://vimeo.com/225977891


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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)


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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,

emails and letters.

Analysis of this data shows a significant reduction in both direct and indirect

contacts pre CGM in 2016 and post CGM in 2017. The charts illustrate the

reduction in clinical contact with the pilot group.

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.

84

12 4

27 35

4 2

11

0

10

20

30

40

50

60

70

80

90

Face to Face contacts

phone calls letter emails

DSN contact 2016 pre CGM

DSN contact 2017 post CGM


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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@1000 £3000

General Hospital bed 3@1000 £3000

A&E visit 2@£127 £254

GP consultations 55 £45

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.

pre CGM Post CGM

0

10

20

30

40

50

60 Number of GP appointments


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Case Study: Participant ‘H’

Outline of the case study of participant H, a working mum, with Type 1

Diabetes, who was pregnant with her 3rd 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.


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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 3rd 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.


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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.

Documents

Continuous Glucose Monitoring - TEC Scotland · 2019-08-29 · Glucose Monitoring: Programme Evaluation 9 Outputs and Impact Ipro 2 (sensor only) Treatment In total 17 patients were