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Transcript of T1D Exchange Clinic Network - Ningapi.ning.com/files/iRPFRg2AvJE*xMVIArJSXD0... · T1D Exchange...
©2016 International Diabetes Center
Beth Olson, BAN, RN, CDE
International Diabetes Center
T1D Exchange Clinic RegistryA Snapshot of Type 1 Diabetes in the US
T1D Exchange Clinic Network
N = 75 Clinics
~27,000 Participants
©2016 International Diabetes Center
CLINIC REGISTRYCURRENT PARTICIPANT CHARACTERISTICS
Age Distribution – Current
718
3219
4935
2751 2669
1645834
0
1000
2000
3000
4000
5000
6000
<6 6-<13
13-<18
18-<26
26-<50
50-<65
≥65
Age (years)
N= 16,771
©2016 International Diabetes Center
Duration of T1D - Current
551
3210
52244162
1483 1085 1056
0
2500
5000
7500
10000
<1 1-4 5-9 10-19 20-29 30-39 ≥40
Duration (years)
Many with T1D Are Overweight /Obese
36% 33%38%
44%
65% 67%
46%
31%
41%46%
68% 66%
0%
20%
40%
60%
80%
100%
<6 6-<13 13-<18 18-<26 26-<50 ≥50Age (years)
Enrolled 9/1/2010 - 8/1/2012Current 1/1/2015 - 12/31/2015
©2016 International Diabetes Center
Insulin Pump Use Is Increasing
57%50%
58% 55% 53%
62% 60%54%
64% 63%67%
63%59%
66% 65% 62%
0%
20%
40%
60%
80%
100%
Overall <6 6-<13 13-<18 18-<26 26-<50 50-<65 ≥65Age (years)
Enrolled 9/1/2010 - 8/1/2012
Current 1/1/2015 - 12/31/2015
Racial Disparities Exist in Pump Use
69%65%
35% 38%
49% 48%
0%
10%
20%
30%
40%
50%
60%
70%
80%
<18 yrs ≥18 yrs
Pum
p %
Age Group
White Afr-Am Hispanic
©2016 International Diabetes Center
CGM Use Is Increasing But Still Low
4% 4% 3% 4%
15% 16%10%
32%
17%
10% 12%
27% 27%
18%
0%
10%
20%
30%
40%
50%
<6 6-<13 13-<18 18-<26 26-<50 50-<65 ≥ 65
Age (years)
Enrolled 2010-2012 (7% use CGM overall)
Current 2015 (17% use CGM overall)
GLYCEMIC CONTROL
©2016 International Diabetes Center
Average Current HbA1c by Age
*≤2 years old and ≥80 years old are pooled
Current HbA1c: Slightly Worse in Youth Than at Enrollment
8.28.3
8.7
8.4
7.77.6
7.4
8.2
8.4
9.0
8.7
7.7 7.67.4
7.0%
7.5%
8.0%
8.5%
9.0%
<6 6-<13 13-<18 18-<26 26-<50 50-<65 ≥ 65
Mea
n H
bA1c
Age (years)
Enrolled 2010-2012Current 2015
©2016 International Diabetes Center
Lower HbA1c in Insulin Pump Users
8.6%
9.3%
7.8%
8.2%
8.6%
7.6%
7.0%
7.5%
8.0%
8.5%
9.0%
9.5%
<13 13-<26 ≥26
Mea
n H
bA1c
%
Age, years
Injection Insulin Pump
Manuscripts and Presentations
85 abstracts submitted and/or presented at national or international meetings through Feb 2016
Over 30 manuscripts
www.t1dexchange.org
©2016 International Diabetes Center
CLINIC NETWORK STUDIES
Recently Completed Clinic Network Studies
Racial Differences in Mean CGM Glucose in Relation to HbA1c—will be presented at ADA this year
Metformin Randomized Clinical Trial
Severe Hypoglycemia in Older Adults
Intranasal Glucagon Study (adult)
Intranasal Glucagon Study (pediatrics)
Health Care Transition Experience and Glycemic Control in Young Adults with T1D
Celiac Disease
©2016 International Diabetes Center
METFORMIN RANDOMIZEDCLINICAL TRIAL (RCT)
Background
Metformin is the first line treatment for type 2 diabetes (T2D) in pediatrics, and like T2D, youth with T1D also clearly have IR.
Whether metformin improves glycemic control in adolescents with T1D has not been established in a large RCT.
Two small 3-month RCTs [Hamilton et al. 2003, (N=27) and Sarnblad et al. 2003, (N=30)] in adolescents with IR found a significantly lower HbA1c in the metformin group compared with the placebo group.
©2016 International Diabetes Center
Study Objective
To evaluate the efficacy and safety of metformin as adjunct therapy in overweight/obese adolescents with T1D with HbA1c levels above the target range
Study Design
Randomized, double-blind, placebo-controlled, multi-center clinical trial
26 pediatric endocrinology clinics in T1D Exchange
Sample Size: 140 adolescents age 12-19 years
Treatment Groups:
2000 mg metformin plus basal-bolus insulin
Placebo plus basal-bolus insulin
1:1 Randomization
©2016 International Diabetes Center
Major Inclusion Criteria
Autoimmune T1D – diagnosed < age 10 years or history of positive β-cell autoantibodies
Diabetes duration of at least 1 year
HbA1c 7.5%-9.9%
BMI ≥85th percentile
Total Daily Insulin (TDI) ≥0.8 units/kg per day
Self‐Monitoring Blood Glucose (SMBG) ≥3 times per day
Summary
Despite initial improvement at 3 months, 6 months of adjunctive metformin therapy did not improve glycemia in overweight/obese adolescents with T1D and HbA1c between 7.5-10%.
Metformin was effective in reducing insulin requirements and had beneficial effects on measures of adiposity, including reductions in weight gain, BMI and body fat
©2016 International Diabetes Center
SEVERE HYPOGLYCEMIA (SH) IN OLDER ADULTS
Frequency of Severe Hypoglycemia* is Related to T1D Duration
8% 8% 7%
12% 13%
16%
20%17%
21%
0%
10%
20%
30%
26-<50 50-<65 ≥65Age, yrs
<20 years 20-<40 years ≥40 yearsDiabetes Duration
Weinstock 2013
* seizure/loss of consciousness in the past year
©2016 International Diabetes Center
Protocol Overview
Primary Objective: Identify factors associated with the occurrence of severe hypoglycemia in older adults with type 1 diabetes
Participants: Age ≥60 yrs old and duration of T1D ≥20 yrs
Case-control study design
Case: SH* in past 12 months
Control: No SH* in past 3 years
*Defined as an event requiring assistance of another person to treat
Conducted at 18 US diabetes centers
Cases and controls matched on clinic and age
Testing Assessments of cognitive, functional, and
psychosocial measures
Lab tests: HbA1c, C-peptide, creatinine, and glucose
Blinded CGM for up to 2 weeks
Methods
©2016 International Diabetes Center
Diabetes Management and Clinical Factors
Case Control P value
Pump Use 58% 59% 0.99
Self-Monitoring of Blood Glucose- mean
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
Case and Control Comparisons
Cases and controls similar on:
Diabetes Numeracy Test
Functional Activities Questionnaire
Geriatric Depression Scale
©2016 International Diabetes Center
Montreal Cognitive Assessment (MoCA)
16% 7%
32%32%
52% 61%
0%
20%
40%
60%
80%
100%
Cases Controls
<22 22-25 ≥26
Mean MoCA=25 Mean MoCA=26
Final score of ≥26 is considered normal
P=0.04
HbA1c Similar in Cases and Controls
7.8% 7.7%
6.0%
7.0%
8.0%
9.0%
10.0%
Cases Controls
Mea
n H
bA1c
, %
Mean HbA1c
P=0.06
26% 28%
0%
10%
20%
30%
40%
50%
Cases Controls
% w
ith H
bA1c
<7.
0%
HbA1c <7.0%
P=0.44
©2016 International Diabetes Center
CGM-measured Hypoglycemia
99
65
39
76
43
23
0
20
40
60
80
100
120
140
160
<70 mg/dl <60 mg/dl <50 mg/dl
Ave
rage
min
utes
/day
Cases Controls
P=0.15
P=0.13
P=0.12
More Hypoglycemia Unawareness in Cases Than Controls
58%
25%
0%
20%
40%
60%
80%
Cases Controls
P<0.001
Symptoms Never/Rarely/Sometimes Present When Blood Glucose Low=Reduced Awareness
©2016 International Diabetes Center
Beta Blocker Use More Common in Cases Than Controls
40%
21%
0%
20%
40%
60%
80%
Cases Controls
P=0.006
Summary
Cases and controls had similar mean glucose and HbA1c
Cases had increased hypoglycemia unawareness increased CGM glucose variability trend towards more CGM hypoglycemiagreater fear of hypoglycemia slightly higher daily frequency of blood glucose
monitoring greater use of beta blockers
©2016 International Diabetes Center
Summary
Some differences in cognition found between cases and controls, with more cases showing reduced capacity
Direction of association between reduced cognition and frequency of SH uncertain
No differences found in daily functioning, depression, diabetes numeracy, or detectable C-peptide
Conclusions
Tight glycemic control not an explanatory factor for high rate of SH in older adults with longstanding T1D
A combination of hypoglycemia unawareness and high glucose variability appears to increase risk of SH
CGM may address the risk of SH in this population
Further studies are needed
©2016 International Diabetes Center
Current Clinic Network Studies
REPLACE BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring
Mini-Dose Glucagon for Adults with T1D
Use of Mini-Dose Glucagon to Prevent Exercise-induced Hypoglycemia
Beta-Cell Function and Glucose Counter-Regulation During Progression of T1D
Improving Family Management and Glycemic Control in Youth <8 Years Old with T1D– Qualitative Phase
REPLACE - BG
TO BE COMPLETED IN SEPT. 2016
©2016 International Diabetes Center
REPLACE – BG (clinicaltrials.gov)
Primary objective: To determine whether the routine use of CGM without BGM confirmation is as safe and effective as CGM used as an adjunct to BGM
STUDY DESIGN
Parallel group, multi-center, randomized, non-inferiority clinical trial
Primary outcome: Time in range of 70 to 180 mg/dl, measured with CGM over 6 months of the study
Sample Size: 226 Randomized Adults
Treatment Groups: (2:1): CGM only CGM + BGM
©2016 International Diabetes Center
CGM ONLY GROUP
Uses CGM as main device for managing diabetes
Uses blinded BG meter when taking insulin, preventing or treating a low BG and at bedtime
Enters CGM value into bolus wizard if dosing
Uses standard BG meter for specific situations such as sensor calibration, hyperglycemia, illness and if questionable CGM reading
References
Beck RW, etal.The T1D Exchange Clinic Registry. J Clin Endocrinol Metab 2012;97:4383-9.
Libman IM., etal. Effects of metformin added to insulin glycemic control among overweight/obese adolescents with type 1 diabetes. JAMA. 2015;314(21):2241-50.
Weinstock RS, etal. Risk factors associated withsevere hypoglycemia in older adults with type 1 diabetes. Diabetes Care. 2016. In Press.