Lessons From The Type 1 Diabetes Exchange

Transcription

1 Lessons From The Type 1 Diabetes Exchange Andrew Ahmann, MD Harold Schnitzer Diabetes Health Center at OHSU

2 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

3 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.

4 What is the T1D Exchange? Clinic Registry Biobank Patient Website Glu

5 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

6 Clinical Centers Types of Patients Adult Pediatric Both N = 75 clinics 15 Setting Institution Managed Care 1 Community 59 23

7 T1D Exchange Clinic Network

8 Age Distribution Current <6 6- < <18 <26 Age (years) 26- < <65 65

9 Duration of T1D - Current < Duration (years)

10 Frequency of Overweight / Obesity 65% 66% 32% 32% 39% 42%

11 Current HbA1C: Little Change Recently Mean HbA1c 9.0% 8.5% 8.0% 7.5% Enrolled Current % <6 6-<13 13-<18 18-<26 26-<50 50-<65 65 Age (years)

12 ADA HbA1c Targets Not Met by Most 100% 80% Enrolled 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-< Age (years)

13 Average Current HbA1c by Age * 2 years old and 80 years old are pooled

14 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% SMBG # Per Day

15 SMBG per Day Injections Only Injections + CGM Pump Only Pump + CGM Mean SMBG per Day

16 Insulin Pump Use Is Increasing 100% 80% 60% 57% 64% 63% 50% Enrolled 9/1/2010-8/1/2012 Current 1/1/ /31/ % 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)

17 CGM Use Is Increasing But Still Low 0% 0% 0% 32% Enrolled (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%

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)

19 CGM Device Type: Shift Towards Dexcom Enrolled Medtronic Dexcom Abbott Current % 45% 31% 69% 2%

20 CGM Device Type by Insulin Delivery Method 00% DexCom Medtronic 96% 80% 60% 64% 40% 20% 0% Pump N = % Injections N = 398 4%

21 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% % <13 N= N=8489 Age (years) 26 N=5669

22 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

23 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

24 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 %

25 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)

26 12-month Frequency of Severe Hypoglycemia* According to Age *1 or more events: defined as seizure or loss of consciousness

27 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

28 12-month Frequency of Severe Hypoglycemia* According to HbA1c Level * Seizure or LOC: 1 or more events

29 12-month Frequency of Severe Hypoglycemia in Pump users vs. Injection users Age (yrs)

30 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

31 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= % 7.7% Cases Controls % with HbA1c <7.0% 50% 40% 30% 20% 10% 0% HbA1c <7.0% P= % 28% Cases Controls

32 Severe Hypoglycemia in The Elderly CGM-measured Hypoglycemia Cases Controls Median minutes/day P= P= P= <70 mg/dl <60 mg/dl <50 mg/dl

33 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= % P= % 45% 60% 40% 20% 18% 40% 20% 20% 3% 0% Cases Controls 0% Cases Controls

34 Combination of both High Glucose Variability and Hypoglycemia Unawareness 60% 40% P= % 0% 24% Cases 5% Controls

35 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

36 Severe Hypoglycemia Rate by HbA1c Category Mean SH Rate per 100 Patient Years 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 WACDD 0.04

37 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 responses per question Study Recruitment Promotion and recruitment through s, articles, social media Prescreening Research Surveys Cross-sectional & longitudinal data collection

38 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)

39 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%]

40 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%

41 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= *Davis AK. Diabetes Care N=93 N= N=104 N= Duration, yrs N=104 N= N=103 N=56 >40

42 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