Changes In Diabetes Care a history Of Insulin & Pumps Past, Present, and Future

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Changes In Diabetes Care A History Of Insulin & Pumps Past, Present, and Future

  • John Walsh, P.A, C.D.E.

  • Online slide presentation

What We Will Cover

  • Early history of diabetes

  • Discovery of insulin

  • When insulin was found to not be the full answer

  • High glucose as the culprit

  • Lack of change in the A1c since the DCCT

  • Why the dumb insulin pump has not helped

  • What smart pumps offer

  • The promise of intelligent devices

  • The Super Bolus

  • How simple and intelligent timers can help

  • Screen shots from an intelligent device

In 1500 BC Diabetes First Described In Writing

  • Hindu healers wrote that flies and ants were attracted to urine of people with a mysterious disease that caused intense thirst, enormous urine output, and wasting away of the body

250 BC The Word Diabetes First Used

  • Apollonius of Memphis coined the name "diabetes” meaning "to go through" or siphon. He understood that the disease drained more fluid than a person could consume.

  • Gradually the Latin word for honey, "mellitus," was added to diabetes because it made the urine sweet.

Early Diabetes Treatments

  • In 1000, Greek physicians recommended horseback riding to reduce excess urination

  • In the 1800s, bleeding, blistering, and doping were common

  • In 1915, Sir William Osler recommended opium

  • Overfeeding was commonly used to compensate for loss of fluids and weight

  • In the early 1900s a leading American diabetologist, Dr. Frederick Allen, recommended a starvation diet

Early Research

  • In 1798, John Rollo documented excess sugar in the blood and urine

  • In 1813, Claude Bernard linked diabetes to glycogen metabolism

  • In 1869, Paul Langerhans, a German medical student, discovered islet cells in the pancreas

  • In 1889, Joseph von Mehring and Oskar Minkowski created diabetes in dogs by removing the pancreas

  • In 1910, Sharpey-Shafer of Edinburgh suggested a single chemical was missing from the pancreas. He proposed calling this chemical "insulin."

Near Miss

  • In 1908, a young internist in Berlin, Georg Ludwig Zuelzer created a pancreas extract named acomatrol.

  • After injecting acomatrol into a dying diabetic patient, the patient improved at first, but died when the acomatrol was gone

  • Zuelzer filed an American patent in 1911 for a "Pancreas Preparation Suitable for the Treatment of Diabetes”

  • Disappointing results, however, caused his lab to be taken over by the German military during WWI

Other “Pancreas Extractors”

  • American scientist E. L. Scott was partially successful in extracting insulin with alcohol

  • A Romanian, R. C. Paulesco, made an extract from the pancreas that lowered the blood glucose of dogs.

  • Some claim Paulesco may have been the first to discover insulin about 10 years before Banting and Best.

Before Insulin

  • Before insulin was discovered in 1921, everyone with type 1 diabetes died within weeks to years of its onset

1922 Leonard Thompson

  • In Jan, 1922, Banting and Best injected a 14-year-old "charity” patient who weighed 64 lb with 7.5 ml of a "thick brown muck" in each buttock

  • Abscesses developed and he became more acutely ill

  • However, his blood glucose had dropped enough to continue refining what was called "iletin” insulin

  • 6 weeks later, a refined extract caused his blood glucose to fall from 520 to 120 mg/dL in 24 hours

  • Leonard lived a relatively healthy life for 13 years before dying of pneumonia (no Rx then) at 27

Insulin Production Begins

  • First produced as “Connaught” by the Univ of Toronto

  • On May 30, 1922, Eli Lilly signed an agreement to pay royalties to the University to increase production

  • First bottles contained U-10 insulin

  • 3 to 5 cc were injected at a time

  • Pain and abscesses were common until purer U-40 insulin became available

Impact Of Insulin On Life Expectancy By The 1940’s

Not A Cure

  • Some early users died of hypoglycemia, but insulin seemed a remarkable cure.

  • By the 1940’s, however, diabetic complications began to appear

  • It became clear that injecting insulin was not the full answer

What Caused Complications? High Glucose Versus Genes

  • During the middle of the 20th century, it was unclear whether better glucose control could prevent diabetes complications

DCCT And Other Studies

  • Results

  • Better health

  • Fewer complications

  • Improved sense of well-being

  • More flexible lifestyle

Little Change In A1c Since DCCT

  • 8.6% in 396 Canadian Type 1s in 19922

  • 9.7% in 1,120 German children in 19963

  • 9.7% in in U.S. in NHANES III, 1988 to 1994

  • 8.6% in 2,873 European children and adolescents in 19971

  • 9.2% in 62 Canadian Type 1s in 2004

We Know What Controls The A1c

  • Frequency of testing

  • 378 pump (pre-smart) users Paul Davidson et al: Diabetes

Controls The A1c

  • Frequency of daily boluses

  • 377 1-18 yo pump users, r = 0.068 TJ Battelino et al: Diabetes 2004

  • For injections: MP Garancini et al: Diabetes Care, 1997, 20, #11: 1659-1663

Controls The A1c

  • Recording of BGs

    • 0.5% drop in A1c in several studies
  • Diet Approach1

    • CHO Counting
    • Regulated
    • WAG

Pre/Post DCCT A1c Results

What Causes High A1cs?

  • Inaccurate carb counting *

  • Insulin doses that are incorrect, misunderstood, or missed entirely *

  • Too hard to log all the data *

  • Not adapting to spontaneous events *

  • Complexity of the challenge *

  • Unclear accountability *

Noncompliance is not a patient problem. It is a system failure. Dr. Paul Farmer First to successfully use complex drug regimens to treat AIDs and TB in Haiti

Current Treatment Interval (CTI)

  • Unlike many other chronic diseases where CTI is not critical, the current treatment interval in diabetes with a doctor’s visit every 3 to 4 months does not work

Required Treatment Interval (RTI)

  • The required treatment interval in diabetes is every 2 to 5 hours rather than 3 to 4 months

  • This is the typical time interval between decisions that significantly affect glucose levels, such as BG monitoring, food intake, and activity

  • Only something that is both available and intelligent can assist the person with a chronic disease like diabetes

When a system is not working for patients, trying harder will not work. Only changing the care system or our approach to care will work.

Dumb Smart Intelligent Automatic

Today’s Smart Pumps

  • Carb boluses

    • Personalized carb factors for different times of day
    • Easy carb bolus calculations
    • Personalized carb database (soon)
  • Correction boluses

    • Personalized correction factors for different times
    • Easier and safer correction of high BGs
    • Reveal when correction bolus is high, ie > 8% of TDD
  • Combined carb/correction boluses

  • Automatic bolus reduction for Bolus On Board (BOB)

Today’s Smart Pumps

  • Track Bolus On Board

    • Improved bolus accuracy
    • Avoids stacking of bolus insulin
    • Helps prevent hypoglycemia
    • Requires BG reading for accuracy
  • Guide whether carbs or insulin are needed

    • Does not yet warn when carbs are needed

Today’s Smart Pumps

  • Reminders to

    • Test blood glucose after a bolus
    • Warn when bolus delivery was not completed
    • Test blood glucose following a low or high BG
    • Give boluses at certain times of day
    • Change infusion site
  • Direct BG entry from meter

Smart Pumps Do Not:

  • Today’s pumps collect the information needed (insulin doses, BGs, carb intake, and timing), but they do not:

  • Identify problem patterns

  • Automatically test basals and boluses or warn when they are out of balance

  • Suggest dose adjustments

  • Warn of pending lows or suggest carb intake needed for excess BOB

  • Warn when excess correction boluses are used

  • Account for GI differences between foods

  • Guarantee an improved outcome

Intelligent Devices

  • Today’s “smart” pumps are migrating to better pumps, pens, and PDAs

  • Calculus rather than formulas to set bolus amounts

  • Auto analysis of BG patterns

  • Fuzzy and artificial intelligence

  • Provide automatic (retrospective) carb/insulin balance

  • Use of A1c to focus therapy

The Intelligent Device Hypothesis

  • Intelligent devices:

    • provide meaningful advice, *
    • improve lifestyles, *
    • improve medical outcomes with diabetes.*

Smart Vs Intelligent Devices

Intelligent Devices

  • Pumps

  • Pens

  • PDAs

  • Smart Phones

  • Meters

  • A central reporting station where data is filtered for minor versus major problems and who is to be alerted (user, guardian, MD/RN)

Demands On Intelligent Devices

  • Intuitive interface and language

  • Must be impartial and fair

  • Outcome driven – user feels better and is more confident about control

  • Compatible with clinic workflow

  • Well funded

  • Able to rapidly evolve as errors appear

  • Must close the data loop between user and MD

Intelligent Device Ingredients

  • Automatic BG timer

  • Automatic basal decrease

  • Super Bolus

  • Automatic basal/bolus balancing

  • Automatic adjustment when correction boluses are overused

  • Carb list and carb counter

  • Exercise intensity and duration

  • Database intelligence

Intelligent Device Benefits

  • Provide immediate advice on situations

  • Identify common or infrequent patterns

  • Constant surveillance of data for changes

  • Provide real meaning to BG values

  • Integrate well with continuous monitoring and artificial intelligence

Smart Phones And PDAs

  • Fast internet & email communication

  • Convenient remote insulin delivery

  • Larger food and carb database

  • Better graphics for BG analysis, display of patterns, etc

  • Larger event database for long-term analysis

Intelligent Devices

  • 300 personal carb selections with accurate carb counts

  • Carb factor (1:1 TO 1:100)

  • Correction factor (1:4 to 1: 400)

Thoughts And Developments For The Future

Old Basal/Bolus Concepts

  • Basal insulin

    • ~ 50% of daily insulin need
    • Limits hyperglycemia after meals
    • Suppresses glucose production between meals and overnight
  • Bolus insulin (mealtime)

    • Limits hyperglycemia after meals
    • Immediate rise and sharp peak at 1 hour
    • 10% to 20% of total daily insulin requirement at each meal

New: Rapid Basal Reduction

New: The Super Bolus

  • A Super Bolus helps cover high GI foods and prevent postmeal hyperglycemia. A 3 or 4 hour block of basal insulin is turned into a bolus to speed its effect.

New: The Super Bolus

  • To ensure safety and success, the Super Bolus will require some clinical testing:

    • How long can basal delivery be stopped or reduced without increasing the risk for clogging of the infusion line
    • How long (3, 4, 5 hours?) can the basal be lowered before a rebound high will occur once the Super Bolus is gone?
    • Is a reduction of the basal delivery rather than complete stoppage a better policy?
    • If a person sets their basal delivery too low or too high, will this affect a Super Bolus?

New: High BG Super Bolus

New: A Reminder Timer

  • A simple timer alerts the user 25 minutes after a bolus that it is safe to begin eating a high GI meal.

New: An Intelligent Reminder

New: Less Glucose Exposure

New: An Intelligent Reminder

Future Intelligent Devices

  • Useful reminders

Future Pattern Management

  • Finding problem patterns enables solutions

  • Set BG targets

  • Gather and record data

  • Analyze patterns in data

  • Assess factors that influence patterns

  • Recommend action

Only A Few Patterns

  • The relatively low number of BG patterns in diabetes makes them easy to identify:

  • High most of the time

  • Frequent lows

  • High mornings (lunches, dinners, bedtime)

  • Low mornings (lunches, dinners, bedtime)

  • Postmeal spiking

  • High to low

  • Low to high

  • Poor control with little or no pattern

Pattern Analysis: Low-High

Low High Pattern Alert

  • Insulin dose suggestions and an alert about past overtreatment of lows.

Low High Pattern Alert

  • An intelligent device can provide a person’s precise carb requirement when the blood glucose is tested.

Easy Analysis 2

Overnight Basal Patterns

User Interface – Critical Component

  • Despite 30 years of pump and meter development, device communication to the user is still in it’s infancy.

Future Intelligent Devices

  • Carb database for accurate carb counts.

Future Intelligent Devices

  • Suggestion for carb intake or to limit intake based on weight/calorie/carb goals

Future Intelligent Devices

  • A high glucose can be analyzed to determine the magnitude of the error

Future Intelligent Devices

  • Recommended carb intake (or insulin reduction) to balance activity.

Future Intelligent Devices

  • New dose recommendations based on A1c, % of TDD given as correction boluses, and frequency of hypoglycemia

Future Intelligent Devices

  • Pattern alerts and advice

Future Intelligent Devices

  • Fast lab results without calling. Messaging allows physician to make recommendations.

Pump Plus Continuous Monitor

  • Automatic basal and bolus testing

  • Trends allow exact short-term BG predictions for rapid recognition of pending highs or lows

  • Both user and device can relate problems to their source

  • Unfortunately, insulin delivery from an external pump is too slow to create an effective artificial pancreas with this combination

The Closed Loop Will Close Slowly

  • Patents impede device development

  • FDA is slow to allow medical care from a device or via telemedicine

  • Slow acceptance by medical personnel and people with diabetes

  • Liability issues

  • Large financial incentives in current meter and pump technology

Questions ???

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