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Why We Pump. Henry Anhalt, DO, CDE Director, Pediatric Endocrinology and Diabetes Saint Barnabas Medical Center Livingston, NJ. `In the past we had a light that flickered, in the present, a light that flames, and in the future we will have a light that shines over all the land and the sea’

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slide1

Why We Pump

Henry Anhalt, DO, CDE

Director, Pediatric Endocrinology and Diabetes

Saint Barnabas Medical Center

Livingston, NJ

slide2
`In the past we had a light that flickered, in the present, a light that flames, and in the future we will have a light that shines over all the land and the sea’

Winston Churchill

banting 1891 1941 best 1899 1978
BANTING-1891-1941 & BEST-1899-1978

Orthopod who became a physiologist and died in air crash in Newfoundland while on wartime mission

Together they isolated insulin and Banting won the Nobel Prize in 1923 knighted in 1934

prevalence of diabetes in the us
Prevalence of Diabetes in the US

Diagnosed Type 1 Diabetes1.5 Million(1:400-600 children)

Diagnosed Type 2 Diabetes14 million

Undiagnosed Diabetes6 Million

1.5 million new cases of diabetes were diagnosed in people aged 20 years or older in 2005

good glycemic control lower hba 1c reduces incidence of complications
Good Glycemic Control (Lower HbA1c) Reduces Incidence of Complications

DCCT

9  7%

63%

54%

60%

41%*

Kumamoto

9  7%

69%

70%

UKPDS

8  7%

17-21%

24-33%

16%*

HbA1c

Retinopathy

Nephropathy

Neuropathy

Macrovascular disease

* not statistically significant

DCCT Research Group. N Engl J Med. 1993;329:977-986. Ohkubo Y et al. Diabetes Res Clin Pract. 1995;28:103-117. UKPDS 33: Lancet.1998;352:837-853.

hba 1c and microvascular complications
HbA1c and Microvascular Complications

Retinopathy

15

13

11

9

7

5

3

1

Nephropathy

Relative Risk

Neuropathy

7

8

9

10

11

12

HbA1c, %

10

every 1 hba 1c increase above goal elevates the risk of diabetic complications
Every 1% HbA1c Increase Above Goal Elevates the Risk of Diabetic Complications

+37%

Incidence of Diabetes-Related Complications (%)

+21%

+14%

+12%

Increase in Any

Diabetes-Related

Endpoint

Increase in Risk

of Myocardial

Infarction (MI)

Increase in Risk

of Stroke

Increase in Risk

of Microvascular

Complications

Adapted from Stratton et al. BMJ. 2000;321:405-412.

physiology of insulin and blood glucose
Physiology of Insulin and blood glucose

Insulin

secretion

Basal Insulin

Breakfast Lunch Dinner

Blood

glucose

Basal blood glucose

insulin preparations
Insulin Preparations

Onset ofDuration of

ActionPeak Action

Humalog/Novalog5 to 15 min 1 to 2 hr 4 to 6 hr

Human Regular 30 to 60 min 2 to 4 hr 6 to 10 hr

Human NPH 1 to 2 hr 4 to 6 hr 10 to 16 hr

Human Lente 1 to 2 hr 4 to 6 hr 10 to 16 hr

Human Ultralente 2 to 4 hr Unpredictable <24 hr

Lantus 30minutes none 24hr

nph and regular insulin 2 injections
NPH and regular insulin - 2 injections

Bkfst lunch dinner bedtime bkfst

disadvantages of nph regular regimen
Disadvantages of NPH/ Regular regimen
  • No flexibility:
  • Required certain amount of calories a day
  • Skipped meal - hypoglycemia (peak of NPH)
  • Exercise - hypoglycemia (excessive glucose use)
  • At night - hypoglycemia (peak of NPH)
  • Overeating- hyperglycemia (not enough)
  • Oversleeping- hyperglycemia(skipped dose)
results of conventional therapy
Results of conventional therapy
  • Poor control - HbA1C 10% and higher
  • Fear of hypoglycemia - worsening of control
  • Inability to exercise - poor fitness
  • Early development of complications
  • “OUT OF CONTROL”-Negative reinforcement
  • “Don’t Do This, Don’t Do That”
  • Mauriac syndrome - chronic insulin deficiency - stunted growth, hepatomegaly
slide17
Some causes of hypoglycemia in toddlers and preschoolers:
  • Unpredictable food intake and physical activity.
  • Imprecise administration of low doses of insulin.
  • Frequent viral infections.
  • Inability to convey the symptoms of low blood sugar.

Adapted from Litton J et al; J Pediatr 2002;141:490-495.

slide20

Dr. Arnold Kadish of Los Angeles, California, devised the first insulin pump in the early 1960s. It was worn on the back and was roughly the size of a Marine backpack

humalog novolog versus regular
Humalog/Novolog versus Regular
  • Rapid acting insulins: Start in 10min Peak in 1-2h Gone in 3.5-4h
  • Regular insulin: Starts in 30min Peaks in 3-4h Gone in 6-8h
benefits of rapid acting insulins
Benefits of rapid acting insulins
  • May be given just prior to the meal or after meal in babies
  • Time of action match rise in sugar caused by most meals
  • No action left at the time of next meal - no boluses buildups
  • Less activity at bedtime - less night “low’s” and no need for bedtime snack
new long acting insulin glargine insulin
New Long Acting Insulin (Glargine Insulin)
  • Lantus is a new type of long acting insulin that has no peaks
  • Mimics physiological insulin (basal)
insulin tactics the basal bolus insulin concept
INSULIN TACTICSThe Basal/Bolus Insulin Concept
  • Basal Insulin
    • Insulin requirement to suppress hepatic glucose production between meals
  • Bolus Insulin (prandial)
    • Insulin requirement to maintain normal glucose disposal after eating
    • Insulin:CHO Ratio = 500/(total starting dose)
    • Correction Factor = 1500/(total starting dose)
    • Correction factor in young children = 1800/(total starting dose)
lantus and novolog poor mans pump
LANTUS AND NOVOLOG-”POOR MANS PUMP”

Lispro

Lispro

Lispro

Insulin Effect

lANTUS

B

L

S

HS

B

Meals

nine preschool patients meticulously cared for with mdi switched to csii
Nine Preschool Patients Meticulously Cared For With MDI Switched To CSII:

Mean A1c 9.5% reduced to 7.9%.

  • Severe hypoglycemic events 0.52 per month reduced to 0.09 per month.
  • Increased parental confidence and independence.
  • All refused to relinquish pump at completion of study.

Adapted from Litton J et al; J Pediatr 2002;141:490-495.

better control and less hypoglycemia in young children
Better Control and Less Hypoglycemia in Young Children

HbA1c

Hypoglycemia

Litton J., J Pediatr 2002;141:490-495.

glycemic memory sustained beneficial effect of prior intensive therapy
Glycemic Memory: Sustained Beneficial Effect Of Prior Intensive Therapy

195 patients between the ages of 13 and 17 in DCCT:

  • Decreased worsening of retinopathy by 74% (p < 0.001).
  • Decreased progression to proliferative or severe non-proliferative retinopathy by 78% (p < 0.007).

Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.

glycemic memory sustained beneficial effect of prior intensive therapy30
Glycemic Memory: Sustained Beneficial Effect Of Prior Intensive Therapy

195 patients between the ages of 13 and 17 in DCCT:

  • Relative risk of hypoglycemia < 1 among prior intensive group.
  • Prevalence of microalbuminuria 48% less.

It is vital to achieve the best glycemic control early in the course in diabetes during adolescence and childhood.

Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.

slide31
“ Less than optimal glycemic control during the early years of diabetes has a lasting detrimental effect on the development and progression of complications, even after better glycemic control is established later in the course of the disease.”

Adapted from White, N et al, J Pediatr. 2001 Dec; 139(6): 804-12.

from preschool to prom
From Preschool to Prom

161 patients with type 1 diabetes:

  • 26 ages 1 to 6
  • 76 ages 7 to 11
  • 59 ages 12 to 18

98% remained on CSII

Reduced hypoglycemia (events/year)

  • Age 1 to 6: 0.42 to 0.19
  • Age 7 to 11: 0.33 to 0.22
  • Age 12 to 18: 0.33 to 0.27

Mean HbA1c levels

Adapted from Ahern J et al; Pediatr Diabetes. 2002 Mar;3(1): 10-5.

i was a non beleiver
I WAS A NON-BELEIVER
  • TOO HARD/TIME CONSUMING
  • I WAS UNINFORMED ON HOW TO USE THEM
  • NOT FOR THE VERY YOUNG OR THE UNMOTIVATED
  • ONLY AFTER HONEYMOON
  • YOU HAVE TO TEST FOR ME TO PUT YOU ON PUMP
  • YOU WILL SUFFER PSYCHOLOGICALLY
introduction
Introduction
  • Test the feasibility and efficacy of insulin pump therapy initiated within the first month of diagnosis
  • N=28 consecutive. mean age 12.1+ 6.2 years
  • Range of start 1-30 days
  • None discontinued after up to three year follow-up
  • 2 sites Cornell Medical Center and Maimonides Medical Center
hypothesis
Hypothesis
  • Our hypothesis are:
    • Patients on pump have better control of their blood glucose level
    • Better control allows extension of the “honey moon” period
rationale and hypothesis
Rationale and Hypothesis
  • Earlier aggressive glucose control leads to lower incidence of long-term complications
  • Insulin pump therapy resembles physiology more closely than multiple daily injections
  • Lower incidence of occult and overt serious and moderate hypoglycemia
  • Would there be benefit to introducing pump therapy earlier rather than waiting until further insulinopenia sets in?
demographics
Demographics

Range 26 months to 32 years

Average time to pump start 16 days+ 11 days 3 went straight to pump and 2 started within one week

other significant findings
Other Significant Findings
  • BMI-No significant gains or losses in BMI SD over study time
  • All patients were “self-sufficient” within 3 months
conclusions
Conclusions
  • Starting patients on insulin pump therapy is a viable option at or soon after diagnosis
  • Further studies need to be performed to see if quality of life and long term complications are affected
  • Despite the labor intensivity of this approach the benefits were clear and patients opted to remain on pump therapy after treatment
  • Apparent prolongation of the honeymoon
candidates for pump therapy
Typical Criteria

Only motivated patients

only patients who showed good compliance on previous regimen

Adults and children > 6y old

My Criteria

Any patient who is willing to start and has abilities to learn

May improve compliance

Any age adults and children of any age (independent users 7-80 y old)

Particularly “non-compliant” patients

Candidates for pump therapy
the yale experience
The Yale Experience
  • > 200 children started on pumps over last 5 yrs
  • No difference in severe hypoglycemia
  • Parents report less mild hypoglycemia

Ahern et al., Journal of Pediatric Endocrinology and Metabolism 2000, 13(suppl 4):1220.

additional evidence from yale
Additional Evidence From Yale
  • Decreased hypoglycemia
  • No change in BMI or TDD
  • 98% remained on CSII

Ahern, JAH, et.al. Pediatric Diabetes 2002;3:10-15.

csii vs mdi with glargine in children
CSII vs. MDI With Glargine in Children

Randomized, Parallel-group, 16 week study

Subjects at baselineAge: 8-19 yr (mean 12.7 ± 2.7) Type 1 DM > 1 yr duration Standard insulin therapy (2-3 injections/day)

CSII (aspart) n=12

Injectiontherapy

MDI (aspart/glargine) n=14

Boland et al., Diabetes 2003, 52:S1, A45, 192-OR

pump group achieved better control overall

p=.30

p=.15 (NS)

(NS)

p=.001

p = .03

Pump Group Achieved Better Control Overall

Changes in HbA1c Levels

8.5

8

7.5

Pump

7

MDI

6.5

Baseline

4 wks

8 wks

12 wks

16 wks

Boland, E. Diabetes 52,(Suppl 1), 2003 Abstract 192.

more pump wearers achieved hba1c 6 9

50

40

30

20

10

0

More Pump Wearers Achieved HbA1c 6.9%

_

<

% Patients Achieving

HbA1c

6.9%

<

Pump Glargine

Boland, E. Diabetes 52,(Suppl 1), 2003 Abstract 192.

sweden s experience
Sweden’s Experience
  • 89 children 3-21 y.o
  • Diabetes duration 6.1 years
  • 30% using CSII
  • HbA1c decreased from 9.2% to 8.4% after CSII start
  • Severe hypos
    • Pump: 11.1/100 pt years
    • MDI: 40.3/100 pt years

Hanas, Diabetes, 2000, 49 (Suppl 1):A133.

.

patient characteristics of successful pediatric pumpers
Patient Characteristics of Successful Pediatric Pumpers
  • Able to maintain follow up appointments with health care provider
  • Willing to record blood glucose values
  • Able to count carbohydrates
  • Good family/social support system
pump therapy benefits
Pump therapy benefits
  • Improved control - more physiological basal rates (“dawn phenomenon” match), different boluses for food, less absorption variability
  • Less hypoglycemia
  • More flexible lifestyle and possibility to exercise
  • Precise dosing - 0.1u - 0.025u increments for basal rate and boluses
  • Less injections - improved quality of life
  • Less possibility of overdose

Adapted from Plotnick L et al; Diabetes Care 2003; 26(4):1142-1146.

pump use in children is increasing
Pump Use in Children Is Increasing
  • 200,000 users (adults and kids in the US). 10,000 are adults with type 2 diabetes
  • ~ 20,000 children using pump therapy
    • 10% of all children with diabetes
  • Penetration as high as 90% in some pediatric clinics (ours)
  • Increasing use in younger children (as young as 10 months)
  • Current outcomes indicate CSII is safe and effective in children
  • Increasing acceptance likely due to DCCT findings as well as the introduction of smaller, safer insulin pumps
  • There are approximately 400,000 insulin pump users worldwide
avoiding dka
Avoiding DKA
  • Give a pen with the pump
  • Instruct that any time the patient feels nauseated or has abdominal pain -- change the site
  • Blood sugar is greater than 250 mg/dl
    • Take correction dose
    • Check for ketones
    • Recheck in 60 minutes
      • If coming down, leave alone
      • If not, take a shot and change the site
summary
Summary
  • Pump therapy is an intensive process for pediatric patients and their families and the diabetes education team.
  • Successful pumpers are motivated and willing to maintain follow-up, carbohydrate count, and check blood glucose frequently.
  • Benefits of pump therapy for pediatric patients include: improved lifestyle, decrease in hypoglycemia, accurate dosing , ability to review history to see if doses were actually given.
summary61
Summary
  • Children with diabetes should be intensively treated to avoid short and long term complications
  • Insulin pumps can provide better control and less hypoglycemia than MDI
  • With good support and a standardized process, insulin pump therapy can help to improve diabetes management in children
  • Insulin pump therapy should be the only form of therapy offered to children with diabetes
slide62
When meditating over a disease, I never think of finding a remedy for it, but rather, a means of preventing it.Louis Pasteur, 1884