insulin pumps and sensors: past, present and future - acp · over 1,000,000 people worldwide now...

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Insulin pumps and continuous glucose monitors: Past, present and future Carla Cox, PhD, RD, CDE, CPT

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Page 1: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Insulin pumps and

continuous glucose

monitors: Past, present

and future Carla Cox, PhD, RD, CDE, CPT

Page 2: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The frustrations of type 1 diabetes

management

Too many variables

Too many finger sticks

Some privacy issues (not wanting to check BG in public)

Too many decisions (one self expert suggested 300 decisions per day!)

Lots of frustration when BG response is NOT at all what was expected!

Page 3: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

What is insulin for anyway?

Page 4: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Insulin delivery systems – read TOOLS to

deliver insulin

Syringes

Insulin pens

Ports

Pumps

Inhaled

Page 5: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Over 1,000,000 people worldwide now use

insulin pumps and they are Rx’d by 2000 US

physicians

Who is a candidate?

Anyone on multiple daily

injections

Generally type 1 patients

Medicaid and Medicare – low C-

peptide (110% or lower of the

normal lab measurement) or beta

cell antibody positive

Best performers on pumps are

generally those who are best

performers on shots – it is a tool

not a miracle

(1) Glycosylated hemoglobin level

(HbAlc) > 7.0 percent

(2) History of recurring hypoglycemia

(3) Wide fluctuations in blood glucose

before mealtime

(4) Dawn phenomenon with fasting blood

sugars frequently exceeding 200 mg/dl

(5) History of severe glycemic excursions

Page 6: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The look

Then (1970’s) Now (April 2017)

Page 7: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The function

Then

Delivered a basal insulin

Patient figured out the bolus

Insulin – regular – 30-45 minute

onset with 8 + hours insulin action

Considerable hypoglycemia

particularly in children

A backpack!

Now

Delivers a basal insulin

Multiple basal rate options (most

pumps)

Programmed algorithm for insulin

to carb ratio and correction

dosing

Rapid acting insulin – onset 15-20

minutes with 3-5 hours duration of

insulin action

Lower incidence of hypoglycemia

4 oz weight

Automated basal insulin delivery

based on sensor data (Medtronic

670G)

Page 8: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

What does the research support with insulin pump

therapy vs multiple daily injections without sensor

augmented pumps

Most research supports mildly reduced A1C

Improved QOL

Reduced incidence of hypoglycemia (not fully research supported)

What does the research support with insulin

pump therapy (sensor augmented pumps) vs

multiple daily injections

Reduced incidence of hypoglycemia

Improved QOL

Substantial improvement in fasting BG

Page 9: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Who is the “best” candidate?

Ideally -

Performs 4 BG checks daily

Is motivated to achieve optimal BG control

Willing to carry out the tasks of maintaining the insulin pump (new infusion sets,

problem solving mechanical issues etc)

Trained in carbohydrate counting – and pretty spot on

Knowledgeable about pre-meal BG goals and targets

Page 10: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The components of an insulin pump

Infusion set – plastic cannula or metal needle

Reservoir – cylinder or bladder

Insulin delivery device – the programmable portion of the pump

Glucometer imbedded in the delivery device (Omnipod) or transmitting to

the pump (Medtronic and Animas)

Sensor readings incorporated into the pump (Animas, Medtronic, Tandem)

- optional

Page 11: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

What does it do?

Basal delivery – small manually adjustable background dose of insulin

(rapid acting) 24 hours per day; every 12 to 24 hours and multiple options

for programs (ie: one for exercise, one for menstruation etc)

Bolus delivery for food based on initial manual entry – like a

preprogrammed calculator

Bolus delivery for correctional insulin manual with initial manual entry

Target blood glucose for the correctional insulin

Active insulin time

These values are manually set in the pump with the patient at the initial

visit and adjusted as needed via phone or in clinic visits

Page 12: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Pumps presently COMMERCIALLY

available in the US

Medtronic – Revel, 630 G, 670 G

Omnipod

Tandem – T:slim X 2; T:slim G4; T:flex

Animas – Ping and Vibe

Roche Accu-chek combo (?)

Page 13: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Pod only – limited programming

V-Go One touch via

Bolus only

2 unit increments

3 day wear

Page 14: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Sensors: what would you

change if you always

knew what your BG was?

Page 15: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Sensors – what are the options

Continuously checks interstitial sugar 24 hours per day and updates on the

screen every 5 minutes

Small wire (platinum) inserted in the SubQ space

A small delay between BG value and interstitial value

Alarms for high and more importantly – low interstitial readings

Page 16: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Sensors – what are the options

Dexcom G5

Options of going to a receiver OR

a cell phone

Cell phone option also can send

the information to others (parent,

spouse/partner etc)

Medtronic Enlite (630 G or

paradigm) or Guardian

(670 G)

Integrated into the insulin pump

630 G can be turned on to allow

for auto-suspend with low BG

670 G can receive sensor data

and adjust basal insulin along with

suspend before or on low

Cannot send sensor data to other

device (parent’s phone for

example)

Real time – need to “wave”

receiver over sensor

Professional only at this time

Freestyle libre pro

Just released – now sending to the

Tandem pump 8/2017

Page 17: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

CGM in patient using insulin injections

Retrospective study looking at T1D

exchange registry data base of 17,731

individuals

Individuals who used the sensor

consistently had lower A1C levels than

non-CGM users either pump or

injections

Cautious interpretation of this retrospective study -

Foster et al, 2016

Page 18: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The job of the provider, diabetes

educator and patient

To help the patient choose the right pump and potentially sensor for them

(manual dexterity, vision)

To teach them what the pump can and cannot do

To set up the basal rates (the long acting look alike)

To determine the insulin to carb ratio and correction dose (trial and error)

To TEACH the patient how to safely use the pump and how to problem

solve chronic and acute hyperglycemia, hypoglycemia and pump and

infusions set malfunctions

To review insulin pump downloads and to make adjustments in a timely

manner based on the data

To be available 24 X 7 on initiation of pump therapy and beyond

Page 19: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

What is out there now?

Tandem

G5 dexcom sensor integrated on

the screen)

X2 – cloud download upgrades

with blue tooth capabilities

Omnipod

Tubeless – no sensor integration at

this time

Animas

Ping

Vibe (with dexcom sensor

integrated on the screen)

Medtronic

630 G (integrated enlite sensor,

suspend on low)

670 G (integrated guardian sensor

with suspend before low; suspend

on low and auto basal delivery)

V-go – no sensor integration

One basal rate 3 options for pods

- bolus with button push

One touch via (just released) – no

sensor integration. Bolus only – no

basal – need injection for basal

Page 20: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Medtronic 670 G

Automated insulin delivery based

on sensor data

Alert on high and change to safe

mode and then manual mode

with prolonged hyperglycemia

Suspend before low

Suspend on low

Only option for manual

adjustments when in auto mode

are active insulin time and insulin

to carb ratios

Target BG is always 120 mg/dl

with the exception of using 150

mg/dl as a temporary target for

up to 12 hours

The patient has to

TRUST the pump!

Page 21: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

What is out there now?

Some are the do it yourself type!

DIY artificial pancreas

Night Scout

http://www.nightscout.info/wiki/welcome/minimed-

connect-and-nightscout

https://diyps.org/tag/insulin-pump/

Night Scout

diyp

Page 22: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Question of the hour….

What insulin pump company manufactures an insulin pump that has

automated insulin delivery response based on sensor data?

A. Tandem

B. Omnipod

C. Medtronic

D. Animas

Page 23: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Downloads – what

information can you gain by

the ability to download?

At home and in the office (via the cloud or in

office download)

Page 24: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone
Page 25: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone
Page 26: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Printed Overview Report

Page 27: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone
Page 28: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

3 Week CGMS

Sometimes it doesn’t

help to download!

Page 29: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

What are the challenges with insulin

pump use?

Major issues which can

occur

Malfunction of the pump itself

(not too common)

Poor infusion set with bent/kinked

cannula

Mental status

Unable to utilize the pump

functions or have a care giver that

can

Suicidal ideation

Frustrations which can

occur

Consistent supply of infusion sets

from distributor (not an issue when

they come from the pump

company)

Glucose strip “switch” by insurer

(government or private)

Financial – change in insurance,

from private to medicare/

medicaid

Page 30: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Case study

21 year old male recently

diagnosed with type 1 diabetes.

He is going to college and lives

alone. His parents live 2 hours

away and are very worried about

him. He has done well with shots

and is presently checking his BG 3

times daily.

His parents would like to be able

to be notified if his blood glucose

is low. He is most interested in

being able to check his BG less

frequently. But his parents are

encouraging him to consider the

pump with smart guard

technology.

He does not like the idea of being

tethered

What system(s) would you

recommend for their

consideration?

Omnipod with dexcom

Medtronic 670 G

Tandem T-Slim X 2 with dexcom

One touch via

Page 31: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

What about hospital care?

Pumps

Consider the advantages

Consider the downside and who should be disallowed

Data to support

Orders to support

Continuous glucose monitors –

individual – no research data

Professional – limited data

No orders at this time

Our “n” of 1

Page 32: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Coming of age – the artificial pancreas

>$200 million in grants for closed-loop academic research over the last

decade

Page 33: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The future of insulin pump therapy

Page 34: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The future looks awesome!

Omnipod

Initial trials started 9/2016

Omnipod “dashboard” to goal launch late 2017 – integrated

into an android phone with

cloud technology

58 people tested starting at age 6 thus far (3/2017)

Upcoming challenges with

high fat meals and exercise

Fully automated system launch

goal late 2019

Page 35: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The future looks awesome!

Tandem

Coming soon!

Bluetooth technology

– cloud download with

upgrade

Predictive low

glucose suspend –

launch goal summer

2018

Hybrid closed loop –

launch goal late 2018

Page 36: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

The future looks awesome!

Medtronic

GLUCOSE SITTER and the fully

automated insulin pump –

launch date?????

Page 37: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Insulin, glucagon and the sensor: the

dual hormone system

Page 38: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Intra - Peritoneal insulin delivery

Why use it for the artificial pancreas?

60 minute delay due to subcutaneous insulin delivery

Insulin delivery is 20 minutes with pump based IP infusion

Could eliminate the premeal bolus –

Reduced rates of mistiming, incorrect calculations, interrupted meal

Accu-Chek DiaPort system – external insulin pump delivering into the

peritoneal cavity via a port and catheter

Jones et al 2017 (UK)

Page 39: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Implantable pumps

Healthline online survey May,

2011

Willing to try?

38.64% depending on cost

and tradeoffs

45.7% NO (Ewe)

12.86% YES!

Page 40: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Implantable sensor

Seneonics

Page 41: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone
Page 42: Insulin pumps and sensors: Past, present and future - ACP · Over 1,000,000 people worldwide now use insulin pumps and they are Rx’d by 2000 US physicians Who is a candidate? Anyone

Any Questions?