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Why do we Need an Artificial Pancreas? . Why do we Need an Artificial Pancreas?. Georgeanna J Klingensmith, MD Barbara Davis Center Keystone 2010. Georgeanna J Klingensmith, MD Barbara Davis Center Keystone 2010. Why do we need an artificial pancreas?. Current glycemic targets

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why do we need an artificial pancreas

Why do we Need an Artificial Pancreas?

Why do we Need

an Artificial Pancreas?

Georgeanna J Klingensmith, MD

Barbara Davis Center

Keystone 2010

Georgeanna J Klingensmith, MD

Barbara Davis Center

Keystone 2010

why do we need an artificial pancreas2
Why do we need an artificial pancreas?
  • Current glycemic targets
  • Current glycemic outcomes fall short
  • What factors contribute to achieving target glycemia
  • Can current technology allow youth to reach target glycemia?
ada glycemic guidelines
ADA Glycemic Guidelines

Targets

Age A1c %**

< 6yrs 7.5-8.5

6-12 yrs <8

13-18 yrs <7.5

adult <7

** Goals should be individualized, a lower A1C goal is reasonable based on benefit:risk assessment and if it can be achieved without excessive hypoglycemia

Silverstein, et al. Care of Children with type 1 DM. Diabetes Care, 28:186-212, 2005

ADA Standards of Care. Diabetes Care, Suppl 1, 2010

ispad glycemic guidelines for all children and adolescents
ISPAD Glycemic Guidelines for all children and adolescents

A1C = <7.5% for all children

All targets should be individualized

Higher targets are recommended in those with severe hypoglycemia and/or hypoglycemia unawareness

Rewers M, Pihoker C, Donaghue K, Hanas R, Swift P, Klingensmith GJ. Assessment and Monitoring of Glycemic Control. ISPAD clinical consensus guidelines 2009. Ped Diab 2009

risk of progression of complications related to glycemia the dcct study

Severe hypoglycemia

Diabetic retinopathy

Nephropathy

Neuropathy

Microalbuminuria

120

Rate of Severe Hypo. (per 100 patient-years)

100

80

60

40

20

0

Risk of Progression of Complications:Related to Glycemia, the DCCT Study

15

13

11

9

7

5

3

1

Relative Risk

7

8

9

10

11

12

6

HbA1c, %

GJ Klingensmith

DCCT Research Group. N Engl J Med. 1993;329:977-986.

slide6

The DCCT: A1C can be modified and Technology Lowers A1C

1 2 3 4 5 6 7 8 9

DCCT Intervention

DCCT

EDIC Observation

S t u d y Y e a r

the hvidore study group on childhood diabetes a1c for participating centers
The Hvidore Study Group on Childhood DiabetesA1C for participating centers

9.5

9.0

Mean +/- SE

% A1c

Tosoh method

8.5

8.0

Mean A1C 8.2 + 1.4%,

7.5

7.0

Diabetes Care, 30:2245-50, 9/2007

search for diabetes a1c results 6 clinical centers in us
SEARCH for Diabetes A1c Results6 clinical centers in US

Mean duration 5 years

Mean 8.33%

8.24%

N=2999

N=369

“Good”: age specific ADA A1c target

“Poor”: A1c ≥ 9.5%.

“Intermediate”: 1c between “good” and “poor”

Petitti D, et al, J Peds, Nov 2009

factors associated with a1c in multifactorial analysis
Factors associated with A1C in Multifactorial Analysis
  • Age, DM duration < 0.001
  • Insurance status < 0.001
  • Household income < 0.001
  • Parental education < 0.001
  • Race/ ethnicity < 0.001

When the HbA1c is adjusted for all of these factors, mean A1C for T1D = 8.0%

Petitti D, et al, J Peds, Nov 2009

slide11

Insulin Regimen in SEARCH

Type 1, N=2743, duration >1 year

Difference remains significant when controlling for socio-economic factors

Journal of Pediatrics Aug 2009

factors associated with hba1c in multifactorial analysis
Factors associated with HbA1c in Multifactorial Analysis
  • Age, DM duration < 0.001
  • Insurance status < 0.001
  • Household income < 0.001
  • Parental education < 0.001
  • Race/ ethnicity < 0.001
  • Frequency of BG testing < 0.001
  • Type of insulin/ insulin delivery <0.001
improvement in hba1c levels the joslin clinic
Improvement in HbA1c levelsThe Joslin Clinic

Cohort 2 used more intensive management with more frequent SBGM and more on MDI and CSII

A1c significantly lower for Cohort 2 compared to Cohort 1

at baseline (p=0.03) and two-year follow-up (p=0.04)

J Pediatr. 2007 Mar;150(3):279-85

does the latest technology help adolescents
Does the latest technology help adolescents?
  • JDRF sensor study
  • Randomized controlled trial of sensor use vs standard care
  • 3 age groups
    • >25
    • 15-25
    • 8-14

N Engl J Med. 2008. 359(14):1464-76

slide15

30%

86%

50%

Only the >25 group had an improvement in A1C

Diabetes Care, 11/2009, 32 (11), p. 1952

age differences in sensor use at 6 months
Age Differences in Sensor use at 6 months

% sensor >25 yrs 15-25 yrs 8-14 yr

>6d/wk 64% 19%* 25%

*21% of 15-24 year olds were not wearing the sensor at 6 months

Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the JDRF-CGM trialJuvenile Diabetes Research Foundation Continuous Glucose Monitoring Study GroupDiabetes Care. 2010 Jan;33(1):17-22

who successfully uses cgm
Who successfully uses CGM
  • Those >25 years (p<0.001)
  • Those who test more frequently prior to initiation of CGM (p<0.001)
  • Those who wore the device >6 days a week in the initial month (p<0.001)
  • Those who achieved a greater percent of glucose values of 70-180mg/dl in month 1 (p<0.002)

Diabetes Care 2009;32: 1947-1953

do we need an artificial pancreas or is cgm enough
Do we need an ‘artificial pancreas’, or is CGM enough?
  • Some pediatric patients can successfully achieve A1C values <7% without significant hypoglycemia for many years
  • Even within a clinical trail, many cannot achieve a significantly lower A1C with CGM, due to the inability to consistently wear the device
slide19

Why do we need an ‘artificial pancreas’?

  • Current ‘usual’ therapy does not achieve goal A1C values in over 50% of children
  • Using more intensified management can lower A1C levels in many patients
  • The newest current technology - CGM- can also be important in achieving target glycemic levels for some patients
conclusion
Conclusion
  • An artificial pancreas may remove enough of the ‘human error’ and ‘hassle’ factor to allow more patients to achieve success
  • A cure for adolescence would also help