JDRF & the Type 1 Diabetes (T1D) Community JDRF Patient - - PDF document

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Apr 05, 2024 45 likes •107 views

JDRF & the Type 1 Diabetes (T1D) Community JDRF Patient organization Volunteers with personal connection to T1D comprise board & research committee Largest non-profit funder Largest non profit funder of T1D research

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JDRF & the Type 1 Diabetes (T1D) Community

JDRF

Patient organization
Volunteers with personal

connection to T1D comprise board & research committee

Largest non-profit funder

Largest non profit funder

f T1D research

worldwide

Mission: accelerate

breakthroughs to cure, treat, prevent T1D

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Life-threatening autoimmune disease requiring intensive

insulin therapy and monitoring

About Type 1 Diabetes (T1D)

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Intensive insulin therapy provides glycemic control
Adequate glycemic control delays or prevents onset of long

term, serious complications (e.g., kidney failure, blindness, heart attacks, and stroke)

Intensive insulin therapy creates risk and fear of hypoglycemia

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Average Current HbA1c by Age

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How are We Doing? Most with T1D are Not at Goal

7.5 8 8.5 Mean HbA1c 6yo 17yo

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7 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 M Age, years* 30yo

*≤2 years old and ≥80 years old are pooled

HBA1c Goal

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Challenges of Hypoglycemia & Diabetic Ketoacidosis (DKA) in Adults with T1D

Severe Hypoglycemia Resulting in Seizure or Loss of Consciousness in Past 12 Months

Severe

Hypoglycemia is

Diabetic Ketoacidosis Requiring Overnight Hospitalization in Past 12 Months

relatively common, regardless of A1c

DKA risk

increases

dramatically with A1c, but persists at all A1c levels

Severe hypoglycemia can cause seizures, comas, deaths
Mild

d d t h l i

Hypoglycemia is Problematic in All its Forms

Mild and moderate hypoglycemia can cause
Disorientation
Falls, accidents
Work, life disruptions
And can lead to severe episodes
Fear of hypoglycemia can cause poor glucose control

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Studies report that

Nocturnal Hypoglycemia is Especially Dangerous for Individuals with T1D

55% of severe hypoglycemia episodes

ccur during sleep
An estimated 2-4% of

deaths in individuals with T1D have been attributed to severe hypoglycemia

Buckingham B, Block J, Burdick J, et al. Response to nocturnal alarms using a real-time glucose sensor. Diabetes Technol Ther. 2005;7:440– 447; Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care. 2003; 26:1902-1912.

12-MONTH FREQUENCY OF SEVERE HYPOGLYCEMIA* BY AGE

Rates of Hypoglycemia are Too High

7% 9% 11% 13% 16% 6% 8% 10% 12% 14% 16% 18% 20% 5% 4% 5% 0% 2% 4% <6 6-<13 13-<18 18-<26 26-<31 31-<50 50-<65 ≥65 Age (years)

2014 T1D Exchange registry data on file through August 2014 N=14,163 (>70 sites in USA) https://t1dexchange.org/

* 1 or more events in 12 months; Severe hypoglycemia = seizure or loss of consciousness.

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Decision makers are not always aware of or know how to value
ther T1D outcomes such as hypoglycemia

Key Decision Makers are Focused Narrowly on HbA1c

ther T1D outcomes such as hypoglycemia
Impacts decision making related to diabetes therapies
Impacts access to diabetes therapies
Additionally, healthcare provider payments are increasingly

tied to outcomes (e.g., HbA1c), which impacts clinical practice

Collaborative initiative of JDRF, patients, clinicians, researchers

R i i h h HbA1 i

T1D Outcomes Program

Recognition that more than HbA1c matters to patients
Agree on definition and measurement of outcomes like

hypoglycemia to:

Appreciate all types of hypoglycemia as meaningful
Ensure outcomes are measured as endpoints in clinical trials
Gain agreement from regulators on use of outcomes in
Gain agreement from regulators on use of outcomes in

regulatory decision-making

Expand diabetes outcomes accepted by US payers

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How Congress Can Help

Continuous Glucose

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