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©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


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


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


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


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


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


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


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


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.


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


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


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


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


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


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


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


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


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


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


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


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.

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