Lessons From The Type 1 Diabetes Exchange Andrew Ahmann, MD Harold Schnitzer Diabetes Health Center at OHSU
Presenter Disclosure Information In compliance with the accrediting board policies, the American Diabetes Association requires the following disclosure to the participants: Andrew Ahmann, MD Consultant: Dexcom, Inc.; Novo Nordisk, Inc.; Horizon CME; Voluntis Research Support: Medtronic; Dexcom, Inc.; Novo Nordisk,Inc.; Lexicon, NIH, Helmsley Charitable Trust
The Helmsley Charitable Trust Leona Helmsley married Harry Helmsley in 1972 Helmsley Charitable Trust began in 1999 $2.5 Billion went to JDRF - - no other money to diabetes At her death in 2007 the $8 Billion was to go to dogs The Tustees went to court to change this Four trustees including David Panzirer (grandson) His daughter was diagnosed with type 1 DM several months earlier Type 1 Diabetes became one of their primary areas The largest expenditure has been for T1D exchange.
What is the T1D Exchange? Clinic Registry Biobank Patient Website Glu
Clinic Registry Objectives Collect clinical and laboratory data on a large number of patients with type 1 diabetes to: Understand the best approaches to the management of T1D Conduct exploratory/hypothesis-generating analyses Identify patients interested in being contacted about participating in research studies Conduct clinical studies and biobank analyses Collaboration with academic researchers, industry, JDRF, ADA, NIH, and other entities
Clinical Centers Types of Patients Adult Pediatric Both 16 36 N = 75 clinics 15 Setting Institution Managed Care 1 Community 59 23
T1D Exchange Clinic Network
Age Distribution Current 6000 5000 4935 4000 3000 3219 2751 2669 2000 1000 718 1645 834 0 <6 6- <13 13-18- <18 <26 Age (years) 26- <50 50- <65 65
Duration of T1D - Current 10000 7500 5000 2500 0 5224 4162 3210 551 1483 1085 1056 <1 1-4 5-9 10-19 20-29 30-39 40 Duration (years)
Frequency of Overweight / Obesity 65% 66% 32% 32% 39% 42%
Current HbA1C: Little Change Recently Mean HbA1c 9.0% 8.5% 8.0% 7.5% 8.2 8.2 8.3 8.4 8.7 9.0 8.4 8.7 Enrolled 2010-2012 Current 2015 7.7 7.7 7.6 7.6 7.4 7.4 7.0% <6 6-<13 13-<18 18-<26 26-<50 50-<65 65 Age (years)
ADA HbA1c Targets Not Met by Most 100% 80% Enrolled 2010-2012 Current 2015 A1c Goal = <7.5% A1c Goal = <7.0% 60% 40% 20% 24% 23% 24% 22% 22% 16% 17% 14% 31% 28% 28% 27% 36% 32% 0% <6 6-<13 13-<18 18-<26 26-<50 50-< 65 65 Age (years)
Average Current HbA1c by Age * 2 years old and 80 years old are pooled
Lower HbA1c with Increased SMBG Frequency (excludes current CGM users) 11.0% 10.5% 10.0% 9.5% 9.0% 8.5% 8.0% 7.5% 7.0% 6.5% Child ( < 18 Years) 10.0% Adult ( 18 Years) 8.6% 8.8% 7.8% 8.1% 7.8% 7.3% 7.1% 0-3 4-6 6-9 10 SMBG # Per Day
SMBG per Day Injections Only Injections + CGM Pump Only Pump + CGM Mean SMBG per Day 6.0 5.0 4.0 3.0 2.0 1.0 3.9 4.1 5.0 5.4 0.0
Insulin Pump Use Is Increasing 100% 80% 60% 57% 64% 63% 50% Enrolled 9/1/2010-8/1/2012 Current 1/1/2015-12/31/2015 58% 67% 63% 55% 53% 66% 65% 59% 62% 60% 54% 62% 40% 20% 0% Overall <6 6-<13 13-<18 18-<26 26-<50 50-<65 65 Age (years)
CGM Use Is Increasing But Still Low 0% 0% 0% 32% Enrolled 2010-2012 (7% use CGM overall) Current 2015 (17% use CGM overall) 27% 27% 0% 0% 0% 4% 17% 10% 12% 4% 3% 4% 15% 16% 10% <6 6-<13 13-<18 18-<26 26-<50 50-<65 65 Age (years) 18%
CGM Use by Insulin Delivery Method 60% 50% 40% 30% 20% 10% 0% 45% 11% 23% 5% Pump Injection 15% 17% 2% 5% 34% 34% 14% 21% 13% 12% <6 6-<13 13-<18 18-<26 26-<50 50-<64 65 Age (years)
CGM Device Type: Shift Towards Dexcom Enrolled 2010-2012 Medtronic Dexcom Abbott Current 2015 53% 45% 31% 69% 2%
CGM Device Type by Insulin Delivery Method 00% DexCom Medtronic 96% 80% 60% 64% 40% 20% 0% Pump N = 2364 36% Injections N = 398 4%
Lower HbA1c in CGM Users Regardless of Insulin Delivery Method Injection + CGM Pump + CGM Pump Only Injection Only 9.5% 9.3 Mean HbA1c % 9.0% 8.5% 8.0% 7.5% 7.9 7.7 8.3 8.7 8.2 8.1 8.7 7.3 7.3 7.7 7.8 7.0% <13 N=3573 13-25 N=8489 Age (years) 26 N=5669
Lower HbA1c in Insulin Pump Users Injection Insulin Pump 9.5% 9.3% Mean HbA1c % 9.0% 8.5% 8.0% 7.5% 8.6% 8.2% 8.6% 7.8% 7.6% 7.0% <13 13-<26 26 Age, years
Lower HbA1c in CGM Users 9.0% Non CGM Users 9.0% CGM Users Mean HbA1c % 8.5% 8.0% 7.5% 8.5% 7.8% 8.2% 7.8% 7.4% 7.0% <13 13-<26 26 Age, years
Frequency of Diabetic Ketoacidosis* According to HbA1c 30% *1 or more DKA events reported in clinic chart in ~12 months 20% 14% 10% 0% 0% 1% 1% 1% <6.0% 6.0% - <6.5% 6.5% - <7.0% 7.0% - <8.0% 3% 8.0% - <9.0% 5% 9.0% - <10.0% 7% 10.0% - <11.0% 11.0% HbA1c %
Frequency of Diabetic Ketoacidosis* According to Age 10% 8% *1 or more DKA events reported in clinic chart in ~12 months 6% 4% 4% 6% 4% 5% 5% 2% 2% 1% 2% 0% Overall <6 6-<13 13-<18 18-<26 26-<50 50-<65 65 Age (years)
12-month Frequency of Severe Hypoglycemia* According to Age *1 or more events: defined as seizure or loss of consciousness
Frequency of Severe Hypoglycemia* is Related to T1D Duration * seizure/loss of consciousness 30% Diabetes Duration <20 years 20-<40 years 40 years 20% 20% 12% 13% 17% 16% 21% 10% 8% 8% 7% 0% 26-<50 50-<65 65 Age, yrs Weinstock 2013
12-month Frequency of Severe Hypoglycemia* According to HbA1c Level * Seizure or LOC: 1 or more events
12-month Frequency of Severe Hypoglycemia in Pump users vs. Injection users Age (yrs)
Comparing Older Patients Who Have Experienced Severe Hypoglycemia vs Others Case Control P value Pump Use 58% 59% 0.99 Self-Monitoring of Blood Glucosemean 6 times/day 5 times/day 0.02 Exercise- median 6 days/wk 5 days/wk 0.52 Alcohol Use ( 1 day per month of binge drinking) 6% 3% 0.50 Detectable C-Peptide (random) 19% 26% 0.25
Severe Hypoglycemia in Elderly: HbA1c Similar in Cases and Controls Mean HbA1c, % 10.0% 9.0% 8.0% 7.0% 6.0% Mean HbA1c P=0.06 7.8% 7.7% Cases Controls % with HbA1c <7.0% 50% 40% 30% 20% 10% 0% HbA1c <7.0% P=0.44 26% 28% Cases Controls
Severe Hypoglycemia in The Elderly CGM-measured Hypoglycemia 160 140 Cases Controls Median minutes/day 120 100 80 60 40 20 99 P=0.09 76 65 P=0.04 43 P=0.05 39 23 0 <70 mg/dl <60 mg/dl <50 mg/dl
More Hypoglycemia Unawareness in Cases Than Controls 100% No Symptoms Until Glucose <50 mg/dl 100% No Symptoms Until Glucose <40 mg/dl 80% P=0.001 80% P=0.009 60% 45% 60% 40% 20% 18% 40% 20% 20% 3% 0% Cases Controls 0% Cases Controls
Combination of both High Glucose Variability and Hypoglycemia Unawareness 60% 40% P=0.003 20% 0% 24% Cases 5% Controls
Able To Compare International Registries WACDD United States (2010-) - Multi-centre clinic registry - Not population based - Patient questionnaire Germany & Austria (1995-) Western Australia (1987-) - Population-based: >90% of - Population-based: ~99% German & >70% of Austrian children <15 years children with diabetes
Severe Hypoglycemia Rate by HbA1c Category Mean SH Rate per 100 Patient Years 12 10 8 6 4 2 0 T1DX DPV WACDD <7.0% 7.0%-<8.0% 8.0%-<9.0% 9.0% HbA1c Spearman Correlation between A1c and SH Rate T1DX 0.02 DPV -0.01 WACDD 0.04
Data Collection Using Glu Have Patients Go to: myglu.org Question of the Day A snapshot of the Glu community on a variety of topics 200-500 responses per question Study Recruitment Promotion and recruitment through emails, articles, social media Prescreening Research Surveys Cross-sectional & longitudinal data collection
Questions of the Day Generated by Content team, Glu users, and industry members Questions are open for 30 days Have you ever adjusted your basal rates without first discussing it with your healthcare provider? (n=517) Yes 13.9% (72) No 86.1% (445)
Insulin Pump & MDI Use Study (n=350) Objective: To describe demographic and clinical characteristics of current pump users, former pump users, and MDI users Current Pump Users [n=250] Former Pump Users [n=31] MDI Users [n=69] Mean age [T1D duration] 43.1 [24] 41.6 [22.5] 45 [17.6] Gender M: 31% F: 69% M: 19% F: 81% M: 45% F: 55% Household income > $75,000 (%) 51% 43% 44% Recent HbA1c less than 7% 57% 32% 67% Regular use of CGMS [% who found CGMS useful] 66% [89%] 27% [90%] 33% [96%] Regular use of diabetes-related phone apps [% who found phone apps useful] 9% [21%] 22% [45%] 14% [87%] Regular use of diabetes-related web apps [% who found web apps useful] 6% [24%] 0% [N/A] 3% [31%]
CGM Experience Survey (n=222) : Glu Purpose: To describe experiences and perceptions of CGM and MDI use Why have you never tried a CGM? Satisfied with my BGM Too expensive Insurance does not cover CGMs Not familiar with CGMs Do not want something attached to body Think it will be uncomfortable to wear Not as accurate as my BGM Concerned about infections at insertion site Think it will be painful to wear Other 17% 15% 7% 7% 11% Never Used 23% 22% 35% 37% 39%
Detectable C-Peptide by T1D Duration and Diagnosis Age (C-peptide Study) 100% 80% 78% 60% Diagnosed 18 years old Diagnosed >18 years old 60% 40% 46% 20% 35% 19% 16% 20% 9% 7% 6% 0% N=122 N=83 3-5 *Davis AK. Diabetes Care. 2015 N=93 N=67 6-9 N=104 N=93 10-19 Duration, yrs N=104 N=94 20-40 N=103 N=56 >40
Studies, Manuscripts and Presentations Usually about 5-10 ongoing studies at any time About 95 abstracts submitted and/or presented at national or international meetings Nealy 35 manuscripts published Listing included in binder and on website Go to www.t1dexchange.org