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TECHNOLOGY UPDATES IN DIABETES

RADHA ANDUKURI, MD

DIABETES & ENDOCRINE ASSOC.

MARCH 16TH 2019

DISCLOSURES

• Some of the products/technology mentioned are only available in Europe and not yet FDA approved

• Many of the products are currently under FDA review and are not yet approved

• Some of the technology and products mentioned are created by the diabetes patient community and haven’t been approved by the FDA or tested in clinical trials

• Use at your own risk

• USA launch goals are mentioned when known, but many factors impact approval and availability

• It’s hard to find accurate info on USA availability when products aren’t yet FDA approved

LEARNING OBJECTIVES

• Discuss recent technology advancements in diabetes

• Discuss how continuous glucose monitoring works and recent updates in CGM

• Discuss role of continuous glucose monitoring in improving diabetes control

• Discuss advancements in insulin delivery devices/pumps

• List some of the apps/programs that patients can use to analyze their glucose data and

manage their diabetes

TERMINOLOGY

• CGM: Continuous Glucose Monitoring

• RT-CGM : Real-Time Continuous Glucose Monitoring

• CSII: Continuous Subcutaneous Insulin Infusion

• MDI: Multiple Daily Injections

• HCP: Health Care Provider

• CDE: Certified Diabetes Educator

• RNs, RDs (dietitians), Pharmacists, or MDs who have an extra certification in diabetes education

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DIABETES TECHNOLOGY—CONTINUOUS SUBCUTANEOUS INSULIN INFUSION THERAPY AND CONTINUOUS GLUCOSE MONITORING IN ADULTS: AN ENDOCRINE SOCIETY CLINICAL PRACTICE GUIDELINEJCEM NOV 2016

• 1 Insulin pump therapy without sensor augmentation

• 1.1 We recommend continuous subcutaneous insulin infusion (CSII) over analog-based basal-bolus multiple daily injections (MDI) in patients with type 1 diabetes mellitus (T1DM) who have not achieved their A1C goal, as long as the patient and caregivers are willing and able to use the device. (1|⊕⊕⊕○)

• 1.2 We recommend CSII over analog-based basal-bolus MDI in patients with T1DM who have achieved their A1C goal but continue to experience severe hypoglycemia or high glucose variability, as long as the patient and caregivers are willing and able to use the device. (1|⊕⊕○○)

• 1.3 We suggest CSII in patients with T1DM who require increased insulin delivery flexibility or improved satisfaction and are capable of using the device. (2|⊕⊕○○)

DIABETES TECHNOLOGY—CONTINUOUS SUBCUTANEOUS INSULIN INFUSION THERAPY AND CONTINUOUS GLUCOSE MONITORING IN ADULTS: AN ENDOCRINE SOCIETY CLINICAL PRACTICE GUIDELINEJCEM NOV 2016

• 2 Insulin pump therapy in type 2 diabetes mellitus

• 2.1 We suggest CSII with good adherence to monitoring and dosing in patients

with type 2 diabetes mellitus (T2DM) who have poor glycemic control despite

intensive insulin therapy, oral agents, other injectable therapy, and lifestyle

modifications. (2|⊕⊕○○)

DIABETES TECHNOLOGY—CONTINUOUS SUBCUTANEOUS INSULIN INFUSION THERAPY AND CONTINUOUS GLUCOSE MONITORING IN ADULTS: AN ENDOCRINE SOCIETY CLINICAL PRACTICE GUIDELINEJCEM NOV 2016

• 6 Real-time continuous glucose monitors in adult outpatients

• 6.1 We recommend real-time continuous glucose monitoring (RT-CGM) devices

for adult patients with T1DM who have A1C levels above target and who are

willing and able to use these devices on a nearly daily basis. (1|⊕⊕⊕⊕)

• 6.2 We recommend RT-CGM devices for adult patients with well-controlled

T1DM who are willing and able to use these devices on a nearly daily basis.

(1|⊕⊕⊕⊕)

DIABETES TECHNOLOGY—CONTINUOUS SUBCUTANEOUS INSULIN INFUSION THERAPY AND CONTINUOUS GLUCOSE MONITORING IN ADULTS: AN ENDOCRINE SOCIETY CLINICAL PRACTICE GUIDELINEJCEM NOV 2016

• Use of continuous glucose monitoring in adults with type 2 diabetes mellitus

• 6.3 We suggest short-term, intermittent RT-CGM use in adult patients with T2DM (not on prandial insulin) who have A1C levels ≥7% and are willing and able to use the device. (2|⊕⊕○○)

• Education and training on the use of continuous subcutaneous insulin infusion and continuous glucose monitoring

• 6.4 We suggest that adults with T1DM and T2DM who use CSII and continuous glucose monitoring (CGM) receive education, training, and ongoing support to help achieve and maintain individualized glycemic goals. (Ungraded Good Practice Statement)

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WHY CGM AND CSII ?

• Comparison of Different Treatment

Modalities for Type 1 Diabetes,

Including Sensor-Augmented Insulin

Regimens, in 52 Weeks of Follow-Up:

A COMISAIR Study

• Sixty one T1DM followed for 1 year

Soupal et al, Diabetes Technology and Therapeutics Sep 2016

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• In conclusion, in patients with type 1 diabetes with suboptimal glycemic control, both SAIRs, that is, SAP and MDIs + RT-CGM, were superior to MDIs or CSII therapy in reducing HbA1c, hypoglycemia, and the other endpoints.

(SAIR sensor augmented insulin regimen, SAP sensor augmented pump, RT-CGM real time CGM, CSII continuous subcutaneous insulin infusion)

CONTINUOUS GLUCOSE MONITORING(CGM)

• Method to track glucose levels throughout day and night

• Glucometer is a great tool, but does not provide real time data

• Frequent monitoring of blood sugars is needed if few people with wide variation in glucose levels as well as frequent hypoglycemia

CONTINUOUS GLUCOSE MONITORS(CGM)

Transmitter

Sensor

Interstitial fluid

Capillary

Receiver

Glucose

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DEXCOM G5

A. SensorB. TransmitterC. Receiver

Glucose is measured every 5 min Depending on the device, finger sticks need to be done 0‐4 times/day for calibration

DEXCOM G6• Approved March 2018

• Longer wear(10 days), Thinner transmitter, 

Easier insertion

• Direct communication with smart devices

• No calibrations with 2 hour warm up

• Customizable alerts and alarms with predictive 

low alerts

• Can share data with up to 5 followers

• No acetaminophen interference

DEXCOM SHARING: CLARITY

• Data shared with other

caregivers via cloud

• HCP’s can download clarity

data in clinic

MEDTRONIC GUARDIAN SENSOR3

• 7 Day Guardian Sensor 3

• Connects via Bluetooth to Guardian Connect app

• SmartGuard technology

• Sugar.IQ™ intelligent diabetesassistant app• Gives personalized assistance on

glucose patterns and factorsaffecting them

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SMARTGUARD TECHNOLOGY

• Suspends insulin delivery for up to 2

hours and resumes when BS improved

• Enables different levels of automation

• Minimed 630G system

• Low glucose suspend

• Minimed 670G system

• Adaptive insulin delivery

• Predictive low glucose suspend

FREESTYLE LIBREFLASH GLUCOSE MONITORING

• Hybrid between meter and CGM

• 10 Day Sensor/14 day sensor

• No separate transmitter. Must be scanned by reader

• Each scan gives current glucose, a trend arrow, and an 8‐

hour history. Stores data for 8 hours

• Shorter warm up time of 1 hour

• Ascorbic acid and salicylic acid can cause false readings

HCP’s have secure access via LibreViewDaily patterns and daily logs

FREESTYLE LIBRE LINK APP

• FDA approved Nov 2018

• Free app in Apple, android version in

development

• Phone can be used to scan instead of

reader. It has to be scanned every 8

hours to get real time readings

• No alarms or alerts

• LibreLinkUp approved in Europe, to

share and communicate with others

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EVERSENSE SYSTEM

• Senseonics

• FDA approved June 2018

• Inserted subQ as an in‐office procedure

• Calculates and transmits BG every 5 min 

• Rechargeable transmitter needs to be charged every 24-36 hrs

TRADITIONAL CGM EVERSENSE LONG-TERM CGM

• Surface transcutaneous sensor, 7-10 day sensor life

• Receiver/phone alerts

• Dexcom G6 with 2 hour warm up

• Zero finger sticks

• Cannot be reattached

• Not rechargeable

• Remote monitoring and sharing with up to 5 family and friends

• Implantable sensor with 90 day sensor life

• Receiver alerts as well as on-body vibe alerts

• Sensor requires 24 hr warm up

• Calibrations: Initial and daily

• Can be removed and reattached without wasting sensor

• Rechargeable battery

• Remote monitoring and sharing with up to 5 friends and family

ROLE OF CGM IN PREVENTING HYPOGLYCEMIA IN INPATIENT SETTINGS

THE GLUCOSE TELEMETRY SYSTEM

• Pilot study on 5 pts with T2 DM

• BG observed with DEXCOM and transmitted using DEXCOM Follow and Share 2 software

• BG < 85 mg/dl are transmitted to nursing station allowing early intervention to prevent hypoglycemia

Spankis EK. etal, J Diabetes Sci Technology, Jan 2018

CONCLUSION

• This pilot study indicates that the use of CGM values in hospitalized patients can

be successfully transmitted to a monitoring device in the nursing station,

improving patient surveillance in insulin treated patients with diabetes.

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CONCLUSION

• CGM (including flash glucose monitoring) systems are safe and

effective in both type 1 and type 2 diabetes

• Improve quality of glycemic control

• Reduce risk of hypoglycemia

• Permit selection of lower target levels for mean glucose and

HbA1c

INSULIN PUMPS

• Delivers rapid/short acting insulin throughout the day subcutaneously through a catheter placed under the skin

INSULIN PUMPS - MEDTRONIC

530G630G 670G

Artificial pancreas(cloedloops system)

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CONTOUR®NEXT LINK 2.4 Meter

One-press Serter

Guardian® Sensor 3

Guardian® Link 3 Transmitter

MiniMed® 670G Insulin Pump

THE MINIMED® 670G SYSTEM WITH SMARTGUARD® HCL TECHNOLOGYWHAT ARE THE COMPONENTS OF THE SYSTEM?

CareLink® Pro SoftwareCareLink® Personal Software

Indicated for people with type 1 diabetes age 14 and older.

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Increasing levels of automation 

Auto mode:Automatically adjusts basal insulin delivery based on sensor glucose readings to help the patient stay in their target range.

Suspend beforelow:Suspends insulin delivery beforeglucose levels reach a pre-set low.

Suspend on low:Suspends insulin delivery whenglucose levels reach a pre-set low limit.

THE MINIMED 670G SYSTEMSMARTGUARD™ HCL TECHNOLOGY

DETAILS OF THE PIVOTAL TRIAL FOR MINIMED 670G SYSTEMSINGLE ARM, NON‐RANDOMIZED STUDY DESIGN*PUBLISHED IN JAMA, DTT

Study Design

Multicenter: 9 sites in US & 1 site in Israel

Single-arm (no control group)

Non-randomized

Patients

N=124 Type 1 ≥ 2 years A1C < 10% Ages 14-75 yr Pump therapy ≥ 6 months,

with or without CGM

Study Protocol

WARNING: Medtronic performed an evaluation of the MiniMed 670G close loop system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, this device should not be used in anyone under the age of 7 years old. This device should also not be used in patient who require less than a total daily insulin does of 8 units per day because the device requires a minimum of 8 units per day to operate safely.

RUN-IN PERIOD:

Pump + CGM2 weeks

STUDY PERIOD: Auto Mode*3 months

Day 1: HCL Training

(Auto Mode)

Day 7: Auto Mode turned ON

Bergenstal RM, et al. JAMA. 2016;316(13):1407-1408.Garg SK, et al. Diabetes Technol Ther. 2017;19(3):155-163.

A1C LOWERING ACROSS BROAD GLYCEMIC RANGE75% OF PATIENTS LOWERED THEIR A1C

Due to inherent study limitations, caution is advised when attempting to extrapolate these results to new patients. There could be significant differences. Bergenstal RM, et al. JAMA. 2016;316(13):1407-1408.Garg SK, et al. Diabetes Technol Ther. 2017;19(3):155-163; Data on file.

Patients on average experienced 0.5% reduction in A1C* in 3 months

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TANDEM’S T:SLIM X2

• Bright color touch screen and 38% smaller than other pumps

• FDA approved June 2018

• Basal IQ- predictive low glucose suspend system using DEXCOM G6

• Suspends basal insulin delivery when low BS is predicted in 30 min and resumes when BS start to rise

• t:slim X2 mobile app- t:connect

TUBELESS PUMPS: OMNIPOD

Communicate wirelessly to deliver basal and bolus insulin based on personalized settingsPDM must be within 5 feet to communicate with the Pod

Once basal program is set, the Pod will deliver basal insulin 24 hours a day regardless of PDM location

Two part System: Personal Diabetes Manager (PDM) and Pod

OMNIPOD DASH

• Approved summer 2018

• DASH pod: Bluetooth enabled, same size

• DASH PDM: Has modern, intuitive and colorful touchscreen

• Bluetooth wireless technology allows communication with pod, PDM and Contour Next Meter

• Not integrated with CGM

• Can download data to Glooko, automatic uploads when connected to wi-fi will be available soon

OMNIPOD DASH

• Omnipod DISPLAY app for

convenient display of PDM data on

smart phone

• Can share data with 12 people with

Omnipod VIEW app

• Can see PDM and DEXCOM data

alongside each other in “Today View”

app on iphone

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PATCH PUMPS

V-GO

• Disposable pump, mainly for Type 2

Diabetes

• Fill and replace daily

• Fixed basal doses(20,30, 40 units)

• Bolus for meals (up to 36 units daily)

• 2 unit increments for mealtime boluses

SMART PENS

• Inpen by companion medical, FDA approved 2016

• Designed to provide benefits of insulin pump in people who cannot use it

• Designed for U-100 Humalog and Novolog insulins

• Reusable injector pen and an intuitive smart phone interface

• Same size as regular inulin pen

• Temperature tracker and insulin age tracker(reminder in 28 days)

• Battery lasts for 1 year

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CONCLUSIONS

• The application of CGM for closed-loop control is advancing rapidly, with well-documented reduction in risk of hypoglycemia in many carefully controlled studies in multiple locations worldwide applied to multiple patient groups under diverse conditions with progressively more sophisticated sensors, algorithms, usability, and integration with the insulin pump

• FDA has approved one system for commercialization and one can expect many additional systems to follow.

PATIENT AND PROVIDER SOFTWARE : GLOOKO

• Integrates data from most BGM,

CGM, insulin pumps and fitness

trackers

• Annual subscription of $59.95/year

• Free cost if doctor sponsors

TIDEPOOL

• Not-for-profit organization

• Provides free software to people with diabetes and their care teams to make their data more accessible and meaningful

• Supported devices: Dexcom, Omnipod, Tandem, Medtronic, Animas, Contour Meters, Freestyle Meters, OneTouch VerioIQ

• Project to develop FDA regulated Loop which works with commercial insulin pumps and CGM’s in progress

• Download software and add your device, redirects to webpage that uploads data with many options for viewing data, different platforms depending on the device

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APPLE HEALTH

• DEXCOM G5 and G6 apps can integrate with Apple Health App

• Direct communication with Apple watch is still in development, currently requires a compatible iphone to serve as an intermediary

• DEXCOM shares data passively, not real time, there is a 3 hour delay

• Designed to monitor trends over time than real time

• Data from Contour Diabetes App and Contour Next One Glucometer will now populate in Apple Health App blood glucose section after recent update in Nov 2018

DIY INSULIN APPLICATIONS

• Focus on connecting data across

systems to form closed loop

• Currently, needs a Riley Link

working with old insulin pumps

• FDA approved APP intended to work

with insulin pumps and CGMs is

currently in development

Flow chart of current and potential future management options for diabetesDiabetes Technology and Therapeutics June 2017

FUTURE TECHNOLOGIES – FROM INSULET

• Aims to launch Horizon Hybrid

closed loop in 2020

• Plans for pods with concentrated

insulins U-200 and U-500

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FUTURE TECHNOLOGY

• Tandem is set to launch Control IQ algorithm into t:slim X2 pumps in summer 2019 which will be the first closed loop technology

• Insulet aims to launch its Horizon Hybrid closed loop system in 2020

• Bigfoot Biomedical is collaborating with Lilly to develop• Bigfoot Loop, closed loop insulin delivery system with Freestyle Libre CGM

• Bigfoot Inject, Bluetooth connected insulin pen

• Preparing for pivotal trial in 2019, expected to hit markets in 2020

• Ilet Bionic pancreas system by BetaBionics• Dual Insulin and glucagon delivery system

A HELPFUL WEBSITE TO KEEP ABREAST OF NEW ADVANCES IN DIABETES TREATMENT AND TECHNOLOGY:

diatribe.org

Thank you! Questions?