Accepted Manuscript

Type 1 Diabetes in Older Adults: Comparing Treatments and Chronic Compli-

cations in the United States T1D Exchange and the German/Austrian DPV
Registries

Ruth S. Weinstock, Ingrid Schütz-Fuhrmann, Crystal G. Connor, Julia M.

Hermann, David M. Maahs, Morten Schütt, Shivani Agarwal, Sabine E. Hofer,
Roy W. Beck, Reinhard W. Holl, for the T1D Exchange Clinic Network and the
DPV Initiative,

PII: S0168-8227(16)30671-4
DOI: http://dx.doi.org/10.1016/j.diabres.2016.09.024
Reference: DIAB 6761

To appear in: Diabetes Research and Clinical Practice

Received Date: 17 June 2016

Revised Date: 31 August 2016
Accepted Date: 22 September 2016

Please cite this article as: R.S. Weinstock, I. Schütz-Fuhrmann, C.G. Connor, J.M. Hermann, D.M. Maahs, M.
Schütt, S. Agarwal, S.E. Hofer, R.W. Beck, R.W. Holl, for the T1D Exchange Clinic Network and the DPV Initiative,
Type 1 Diabetes in Older Adults: Comparing Treatments and Chronic Complications in the United States T1D
Exchange and the German/Austrian DPV Registries, Diabetes Research and Clinical Practice (2016), doi: http://
dx.doi.org/10.1016/j.diabres.2016.09.024

This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers
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Title: Type 1 Diabetes in Older Adults: Comparing Treatments and Chronic Complications in
the United States T1D Exchange and the German/Austrian DPV Registries

Authors: Ruth S. Weinstock MD, PhD1, Ingrid Schütz-Fuhrmann, MD2, Crystal G. Connor, MS,
MPH3, Julia M. Hermann, MS4,5, David M. Maahs MD, PhD6, Morten Schütt, MD, PhD7,
Shivani Agarwal, MD, MPH8, Sabine E. Hofer, MD, PhD9, Roy W. Beck MD, PhD3, Reinhard
W. Holl MD, PhD4,5 for the T1D Exchange Clinic Network and the DPV Initiative

Author Affilations:
1
SUNY Upstate Medical University, Syracuse, NY USA
2
Hospital Hietzing, 3rd Medical Department, Vienna, Austria
3
Jaeb Center for Health Research, Tampa, FL USA
4
University of Ulm, ZIBMT, Institute of Epidemiology and Medical Biometry, Ulm, Germany,
5
German Center for Diabetes Research (DZD), Munich-Neuherberg, Germany
6
Stanford University, Palo Alto, CA USA
7
Medical University of Lübeck, Department of Internal Medicine, Lübeck, Germay
8
University of Pennsylvania Perelman School of Medicine, Philadelphia, PA USA
9
Medical University of Innsbruck, Department of Pediatrics, Innsbruck, Austria

Corresponding Author: Crystal Connor, Jaeb Center for Health Research, 15310 Amberly
Drive, Suite 350, Tampa, FL 33647; Phone: (813) 975-8690, Fax: (800) 816-7601, E-mail:
T1DStats@jaeb.org

Short Title: Older Adults with Type 1 Diabetes Comparison

Word Count: 2560

Keywords: type 1 diabetes, geriatrics, T1D Diabetes Exchange, DPV

Abbreviations: angiotensin converting enzyme inhibitor (ACE-I), angiotensin receptor blocker

(ARB), body mass index (BMI), glucose monitor (CGM), Diabetes Patienten
Verlaufsdokumentation (DPV), diabetic ketoacidosis (DKA), estimated glomerular filtration rate
(eGFR), hemoglobin A1c (HbA1c), LDL-cholesterol (LDL-chol), self-monitoring of blood
glucose (SMBG), severe hypoglycemia (SH), total daily insulin (TDI), type 1 diabetes (T1D),
Type 1 Diabetes Exchange (T1DX), United States (US)

Page 1 of 29
ABSTRACT

Aims: Compare characteristics, therapies and clinical outcomes in older adults with type 1

diabetes in the United States T1D Exchange (T1DX) and German/Austrian Diabetes Patienten

Verlaufsdokumentation (DPV) registries.

Methods: Cross-sectional study of adults ≥60 years old with type 1 diabetes seen in 2011-2012

in the T1DX (n=1283) and DPV (n=2014) registries. Wilcoxon rank-sum test was used for

continuous variables and chi-square test for categorical variables. Adjusted analyses used

generalized linear models.

Results: Individuals in both registries were similar in body mass index (mean 27 kg/m2),

percent with obesity (25%) and gender (48% male). In T1DX there was longer diabetes duration

(32.3 vs. 28.8 years), greater use of antihypertensive medications (including ACE-I and ARBs;

85% vs 62%), statins (68% vs 40%), aspirin (77% vs 21%), insulin pumps (58% vs. 18%), and

less smoking (7% vs. 10%); lower adjusted mean LDL-cholesterol (84 vs. 109 mg/dL), and

lower adjusted mean systolic and diastolic blood pressures (128 vs. 136 and 68 vs. 74 mmHg);

fewer myocardial infarctions (6% vs. 9% [99% CI of difference, 1% to 5%]), strokes (2% vs. 8%

[3% to 7%]), microvascular complications including microalbuminuria (17% vs. 44% [22% to

32%]) but increased depression (16.1% vs. 8.7%). Adjusted mean HbA1c levels were similar

(7.5% 58 mmol/mol).

Conclusions: Differences between the registries included greater use of antihypertensives,

statins and insulin pumps, and fewer chronic complications in the T1DX. Further research is

needed to better understand the role of intensive therapy in improving outcomes in older adults

with type 1 diabetes.

Page 2 of 29
INTRODUCTION

Older adults with long-standing type 1 diabetes are a growing population globally due to rising

incidence and increasing longevity (1-6), but management strategies for these individuals have

not been a focus of investigation. Most research in older adults has concentrated on people with

type 2 diabetes, many of whom, in contrast to those with T1D, do not need insulin therapy. The

pathophysiology of type 1 diabetes and the development of cardiovascular and renal disease in

type 1 diabetes differs from that observed in type 2 diabetes (7). Reports from the United States

(US) show that the incidence of chronic vascular complications of diabetes, with the exception of

end stage renal disease, has declined in adults ≥65 years of age, but most of these individuals had

type 2 diabetes (8).

Studies examining treatment approaches and complications in type 1 diabetes in the elderly are

lacking. In Germany, patients with type 1 diabetes >60 years of age compared to those ≤60

years demonstrated greater microalbuminuria, retinopathy, myocardial infarctions, and strokes as

well as lower hemoglobin A1c (HbA1c) levels, and less use of insulin pump therapy (9).

Results from the Pittsburgh Epidemiology of Diabetes Complications Study (10) suggest that in

type 1 diabetes, inadequate treatment of hypertension and microalbuminuria relate to major

adverse outcomes of diabetes (diabetes-related death, myocardial infarction, revascularization

procedure/blockage ≥50%, stroke, end stage renal disease, blindness, amputation). Optimal

blood pressure, lipid and glycemic goals (for the prevention of complications) for adults with

type 1 diabetes ≥ 60 years of age are also unclear. These may not be the same as those

recommended for younger patients with type 1 diabetes or for people with type 2 diabetes.

Page 3 of 29
Generally, in the elderly with diabetes, evaluation and management strategies emphasize the

prevention of complications that can adversely affect quality of life. In older adults in good

health, longer-term prevention and treatment of microvascular and macrovascular diabetes-

related complications remain important goals. How best to accomplish these objectives in older

adults with type 1 diabetes is unclear. The primary aim of this study is to compare

demographic and anthropometric characteristics, management approaches, cardiovascular risk

factors, and diabetes-related complications in adults age 60 years or older with type 1 diabetes

from the US and Germany/Austria.

RESEARCH DESIGN AND METHODS

Study Design and Participants

Analyses are based on multi-center cross-sectional observational data of participants from the

T1D Exchange (T1DX) registry (US) and the German/Austrian Diabetes Patienten

Verlaufsdokumentation (DPV) registry who were ≥60 years of age at enrollment and seen in

2011 to 2012. A 1% error margin (ie expressed as 99% confidence intervals of difference) was

used due to the large number of participants.

There were 32 T1DX adult centers that contributed 1283 participants for these analyses; median

number of subjects per site was 58 (minimum n=1, maximum n=113). Information about

diagnosis of type 1 diabetes for inclusion in the registry and data collection methods has been

published (11). Each clinic received approval from a local Institutional Review Board for the

Protection of Human Subjects (IRB). Informed consent was obtained according to IRB

requirements.

Page 4 of 29
The German/Austrian registry data were collected for individuals (n=2014) from specialized

adult diabetes centers in Germany (n=106) and Austria (n=5) through computerized

documentation called the Diabetes Prospective Documentation Initiative [Diabetes Patienten

Verlaufsdokumentation (DPV)]. The median number of subjects per site was 9 (mean 18,

minimum n=1, maximum n=272). As previously described, information was abstracted from the

medical records including patient history every 6 months and from questionnaires (9). Patients

were seen in 2011 or 2012, and agreed to participate verbally or in writing. Ethics-committee

approval was obtained through Ulm University, Germany and by IRBs from participating

centers.

Clinical diagnosis of hypertension, neuropathy, depression, the occurrence of stroke and

myocardial infarction, current smoking, medication use including angiotensin converting enzyme

inhibitors (ACE-I) and angiotensin II receptor blockers (ARBs), treatment for retinopathy, and

frequency of self-monitoring of blood glucose (SMBG) were recorded. Height, weight, body

mass index (BMI), and blood pressure were obtained from the most recent exam at enrollment.

Formal neuropathy testing was not conducted. Laboratory measures included most recent blood

urea nitrogen (BUN), creatinine (Cr), estimated glomerular filtration rate (eGFR) (calculated

using MDRD and CKD-EPI) (12), urine albumin:creatinine, lipid panel, and HbA1c (within 6

months of enrollment). Patients who began insulin pump therapy during the year of analysis

were considered pump users. Information concerning the incidence of hypoglycemia and

diabetic ketoacidosis (DKA) were not directly comparable among the registeries in this dataset

and therefore was not included in the analyses.

Page 5 of 29
Statistical Analyses

Continuous measures were summarized by median/mean ± standard deviations [unless the data

are non-normally distributed then medians and interquartile range (IQR)] and categorical

variables by frequency and percentages. Unadjusted comparisons between the two registries

were based on Wilcoxon rank-sum test for continuous variables and chi-square test for

categorical variables. Confidence intervals for differences in means are differences in least

square means from models with registry as the only independent variable. Bootstrap resampling

with 10,000 replicates was used to calculated the differences in medians (13). Least squares and

logistic regression models were adjusted for age group (60-<70, ≥70 years), diabetes duration

group (0-<10, 10–<30, ≥30 years), gender and the interaction between age group and diabetes

duration group for continuous and categorical outcomes, respectively. Due to multiple

comparisons, two-sided 99% confidence intervals were reported. All reported p-values are two

sided and were computed using SAS systems version 9.4 (SAS Institute, Cary, NC, USA).

RESULTS

Participant Characteristics

Participant characteristics are shown in Table 1. Overall, there were 3297 participants (T1DX

n=1283; DPV n=2014) with an age range of 60.0-93.6 years. Participants in the two registries

were similar in gender (48% male), BMI (mean 27 kg/m2), and prevalence of obesity (25% with

BMI >30 kg/m2). T1DX participants were slightly younger at time of enrollment compared with

DPV (mean age 67.3 vs. 70.8 years; 99% CI of difference, 2.8 to 4.1 years); 73% (n=935) vs.

47% (n=937) were between the ages of 60 and 70 years, and 27% (n=348) vs. 53% (n=1077)

Page 6 of 29
were 70 years or older. However, mean duration of diabetes at enrollment was greater for T1DX

participants (32.3 vs 28.8 years; 99% CI of difference 2.0 to 5.0 years). The use of

antihypertensive medications, including ACE-I and ARBs, and statins were more common in the

T1DX (85% vs 62% and 68% vs 40%, respectively; 99% CI of differences, 18% to 26%, 10%

to 19%, and 23% to 32%, respectively; Table 1).

Cardiovascular Risk Management

Mean systolic and diastolic blood pressures (SBP, DBP) were lower in the T1DX compared to

the DPV (99% CI of adjusted mean difference, 5 mmHg to 9 mmHg and 5 mmHg to 7 mmHg,

respectively). Stratification by antihypertensive medication use (including ACE-I and ARBs) did

not alter this relationship although greater differences were seen among those not using

antihypertensive medications. LDL-cholesterol concentrations were lower in the T1DX

compared to the DPV (84 mg/dL vs 109 mg/dL; 99% CI of adjusted mean difference, 22 mg/dL

to 29 mg/dL), while HDL-cholesterol levels were not significantly different between the two

registries (Table 2). Aspirin use was also significantly different in the two registries (77% in the

TIDX vs. 21% in the DPV; 99% CI of difference, 51% to 60%).

Glycemic Management and Control

Mean HbA1c was similiar between the two registries (7.5%, 58 mmol/mol), but the proportion

of participants with HbA1c <7.5% (<58 mmol/mol) was lower in the T1DX cohort (50% vs.

57%; 99% CI of adjusted difference in porportions, 1% to 11%) as was insulin dosing (0.5 vs 0.7

units/kg; 99% CI of adjusted mean difference, 0.1 to 0.2 units/kg, Table 2). Greater use of insulin

pump therapy and CGM was observed in the T1DX compared to the DPV registry (58% vs 18%;

99% CI of difference, 35% to 44%; Table 1).

Page 7 of 29
Chronic Diabetes Complications

Adjusted rates of individuals with urine albumin 30-300 mg/g Cr (microalbuminuria) were lower

among T1DX participants (17% vs 44%; 99% CI of difference, 22% to 32%; Figure 1). Whereas

a similar percentage of T1DX participants had eGFR <60 ml/min/1.73 m2, a lower adjusted

percentage of T1DX participants had eGFR<30 ml/min/1.73 m2 (3% vs 8%; 99% CI of adjusted

difference in proportions, 2% to 6%; Figure 1B). Additionally after adjustment, neuropathy and

retinopathy were less frequently reported by patients within the T1DX registry (36% vs 70% and

34% vs 40%, respectively; 99% CI of difference, 30% to 40% and 5% to 17%, respectively;

Table 2). Table 4 displays history of chronic diabetes complications stratified by eGFR (≥60,

30-<60 and <30 ml/min/1.73 m2) in each registry. The percentage of participants with

neuropathy and urine albumin 30-300 mg/g Cr were lower in the T1DX across each eGFR

category, and history of stroke lower in those with eGFR ≥60 and 30-<60 ml/min/1.73 m2 in the

T1DX, but these analyses are limited by the small number of cases in many of the groups.

A history of myocardial infarction and stroke was less common in the T1DX compared to the

DPV (adjusted 6% vs 9% and 2% vs 8%, respectively; 99% CI of difference, 1% to 5% and 3%

to 7%, respectively; Figure 1C). Depression was more prevalent among the T1DX participants

(adjusted 16% vs 8%; 99% CI of difference, 3% to 9%; Table 2), despite the lower percent with

diabetes-related complications.

Diabetes Complications and Co-morbidities by Age Group

Page 8 of 29
Outcome measures (HbA1c, blood pressure, lipid levels, , Cr, eGFR) and diabetes-related

complications are shown by age group (60-<70 and ≥70 yrs) in Table 3. Macroalbuminuria

(urine albumin >300 mg/g Cr) was less frequent in the T1DX registry for those 60 to <70 years

(3% vs 6%; 99% CI of adjusted difference in proportions, 1% to 5%) but this was not evident

for those ≥70 years of age (Figure 1A; Table 3). Additionally, a lower prevalence of myocardial

infarction and retinopathy for T1DX participants remained among those aged 60 to <70 years,

but this was not significant in those ≥70 years (Table 3).

CONCLUSION

Individuals with type 1 diabetes have a shortened life expectancy, even with excellent glycemic

control, with cardiovascular disease being a major contributor (14-16). We report fewer

myocardial infarctions and strokes in adults ages ≥60 years of age in the T1DX (US) clinic

registry compared to the German/Austrian DPV, despite similar mean BMI and prevalence of

obesity. In the T1DX, there was also higher statin, antihypertensive, and asprin use, lower blood

pressures and LDL levels (even with stratifying for blood pressure and statin use), and less

microalbuminuria and smoking. When stratified by age group, this difference in macrovascular

events was apparent in those ages 60<70 years, but did not extend to those ≥70 years. The lower

number of participants >70 years old in the T1DX compared to the DPV was a potential

explanation for the differences observed in these analyses.

A reduction in microvascular complications in type 1 diabetes has also been observed in recent

years. In the DCCT/EDIC, after 30 years of type 1 diabetes, less albuminuria and a slower

decline in GFR was found than described earlier (17, 18). The authors proposed that this would

Page 9 of 29
result in a reduction in end stage renal disease later in life (17). Better glycemic and blood

pressure control are considered major contributory factors. In the current report, microvascular

complications were lower in the T1DX compared to the DPV with similar HbA1c values.

Slightly more DPV participants had chronic kidney disease (based on eGFR calculations) than in

the T1DX. The lower percent of T1DX participants with eGFR <30 ml/min/1.73m2 may be

related to higher use of ACE-I and ARBs in the US and/or lower blood pressures. Less

retinopathy and neuropathy were also reported in the T1DX.

Unlike type 2 diabetes, all individuals with type 1 diabetes are severely deficient in insulin and

require insulin therapy. Their glycemic management can be quite challenging. HbA1c levels

may not reflect adequacy of glycemic control, since wide or narrow glycemic excursions can be

observed with the same HbA1c. These factors underlie recommendations for type 1 diabetes

patients to frequently perform SMBG or use CGMs. Few participants were using CGMs; CGMs

are not covered by Medicare and are not generally covered in Germany, but are covered in some

conditions in Austria if medically indicated for insulin pump users only. The T1DX registry

previously reported that use of CGMs was associated with better glycemic control (19), but there

are no randomized studies of CGMs in older adults with type 1 diabetes. There is a need for

further study of CGMs in this population.

The differences in outcomes by age group between registries are striking. The current study’s

results comparing outcomes between the T1DX and DPV in people with type 1 diabetes ≥60

years old contrast with comparisons reported in children <6 years old in which the DPV youth

Page 10 of 29
had lower HbA1c than in the T1DX (20). The differential comparisons between age groups

highlights the value of trans-national comparisons to identify targets to improve outcomes.

In a previous study of adults (median age 34 years) in the T1DX registry who completed the

Patient Health Questionnaire (PHQ-8) as a measure of depression, females were more likely to

be depressed. HbA1c was higher in those who were depressed, and those with depressive

symptoms had more chronic diabetes complications such as myocardial infarction (21). In the

current study of older adults, it is interesting that despite higher reported depression in the

T1DX, there were fewer myocardial infarctions. Potential reasons for higher depression in the

T1DX are unclear. Since the depression diagnosis was from chart review, and not determined

from formal testing, depression may be underreported.

There are several limitations of this study. The data are cross-sectional and observational in

nature. Since data in the T1DX and DPV were collected from diabetes centers (i.e. not

population-based), they may not be representative of older adults with type 1 diabetes followed

in other practice settings (e.g. primary care and nephrology). They may also not be

representative of those with comorbidities since patients may be receiving care from other

specialists. The results, therefore, may not be generalizable to all older adults in the US and

Germany/Austria with type 1 diabetes. Potential differences in data ascertainment are also

possible. History of neuropathy was obtained from the medical record and was not

systematically assessed. In addition, in these populations of older adults with long duration of

type 1 diabetes, glycemic, blood pressure and lipid medication use was not available during the

Page 11 of 29
earlier years of their disease. Lastly, there is the possibility of survival bias, with differences in

mortality rates for adults with type 1 diabetes <60 years of age in each country.

Despite these limitations, to our knowledge, the current study is the first large type 1 diabetes

trans-continental study in older adults and highlights key differences between a US and

German/Austrian national registry with regards to clinical charcteristics, therapies and diabetes-

related chronic complications. Our findings encourage the continued use of trans-national

comparisons to help identify therapeutic targets to improve clinical outcomes.

Despite similar HbA1c concentrations, differences exist between the registries in blood pressure

and lipid management, use of aspirin, insulin pump therapy and CGM, and reported

microvascular and macrovascular diabetes complications. These data support a potential benefit

of increased attention to blood pressure treatment, and statin and aspirin use in older adults with

type 1 diabetes. Further studies are needed to better understand the observed differences and to

determine how to modify current management strategies to improve outcomes.

Page 12 of 29
ACKNOWLEDGMENTS

RSW and CGC researched data and wrote/edied the manuscript. JMH performed statistical

analyses. ISF, DMM, MS, SA, SHE, RWB, and RWH research data and reviewed/edited the

manuscript.

RSW’s non-profit employer is the site for multicenter clinical trials sponsored by Eli Lilly,

Medtronic Inc, Astra-Zeneca, GlaxoSmithKline, Mylan and Calibra. ISF, CGC, JMH, MS, and

SA have no disclosures. DMM is on the advisory board for Insulet and his non-profit employer

has received research funding from Medtronic and Dexcom. SEH has received payments for

lectures from Lilly and Roche. RWH’s non-profit employer has received grants/grants pending

from Sanofi-Aventis for research in type 2 diabetes and Medtronic Switzerland for research on

inpatient care. RWB’s non-profit employer has received consultant payments on his behalf from

Sanofi and Animas and a research grant from NovoNordisk with no personal compensation to

RWB.

RWB and RWH had full access to all of the data in the study and takes responsibility for the

integrity of the data and the accuracy of the data analysis.

FUNDING

The T1D Exchange is supported through the Leona M. and Harry B. Helmsley Charitable Trust.

The DPV is supported through the German BMBF competence network Diabetes mellitus (FKZ

01GI1106), which was integrated into the German Center for Diabetes Research (DZD) as of

January 2015.

Role of Funder Statement

Page 13 of 29
The funders had no role in the design and conduct of the study; collection, management,

analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and

decision to submit the manuscript for publication.

Page 14 of 29
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Table 1. Participant and Clinical Characteristics Comparison of T1DX and DPV

T1DX DPV Unadjusted P-value†
Difference
N=1283 N=2014
(99% CI*)

Age at enrollment (yrs) – Mean (standard deviation) 67.3 (6.0) 70.8 (7.1) -3.4 (-4.1, -2.8) <0.001

60 to <70 years old – N (%) 935 (73) 937 (47) 26 (22, 31) <0.001

≥70 years old – N (%) 348 (27) 1077 (53) -26 (-31, -22)

Gender: Male – N (%) 615 (48) 966 (48) -<1 (-5, 5)** 0.99

Page 17 of 29
Duration of Diabetes (yrs) – Mean (standard 32.3 (16.1) 28.8 (16.0) 3.5 (2.0, 5.0) <0.001
deviation)

0 to <10 years – N (%) 139 (11) 254 (13) -1 (-5, 1) <0.001

10 to <30 years – N (%) 407 (32) 823 (41) -9 (-13, -5)

≥30 years – N (%) 737 (57) 937 (47) 10 (6, 15)

BMI (kg/m2 ) – Mean (standard deviation) 27.3 (5.1) 27.1 (5.1) 0.25 (-0.3, 0.8) 0.22

>30 kg/m2 – N (%) 222 (25) 475 (25) -<1 (-5, 4)** 0.93

SMBG (# per day) – Median (25th, 75th percentile) 5 (4,7) 4 (4,5) 1 (1, 1) <0.001

Pump Use – N (%) 738 (58) 368 (18) 39 (35, 44) <0.001

Injection therapy– N (%) 541 (42) 1646 (82) -39 (-44, -35) <0.001

CGM Use – N (%) 213 (17) 225 (11) 5 (2, 9) <0.001

CGM Days (per year) – Median (25th, 75th 30 (22,30) 6 (4,14) 24 (22, 25) <0.001
percentile)

Smokers – N (%) 82 (7) 163 (10) -3 (-6, -1) 0.002

Statin Use – N (%) 867 (68) 815 (40) 27 (23, 32) <0.001

Anti-hypertensive Use – N (%) 934 (85) 1257 (62) 22 (18, 26) <0.001

ACE-I/ARB Use – N (%) 812 (64) 997 (50) 14 (10, 19) <0.001

Aspirin Use – N (%) 722 (77) 429 (21) 55 (51, 60) <0.001

*Confidence intervals for differences in means are the differences in least square means from models
with registry as the only independent variable. Confidence intervals for the differences in medians are
from bootstrap resampling
† P-values from Wilcoxon rank sum test for continuous variables and from Chi-square test for categorical
variables
**
Unadjusted difference not significant

Page 18 of 29
Table 2. Clinical Outcomes Comparison of T1DX and DPV
T1DX DPV Adjusted* Difference Adjusted* P-Value

N=1283 N=2014 (99% CI)

HbA1c (%, mmol/mol) – Mean (standard deviation) 7.5 (1.0), 7.5 (1.4) -0.1 (-0.2, 0.1) 0.14

58 (10.9) 58 (15.3)

<7.5% (<58 mmol/mol) – N (%) 635 (50) 1054 (57) -6 (-11, -1) 0.002

<8.0% (<64 mmol/mol) – N (%) 893 (71) 1303 (71) 0 (-4, 5) 0.78

<8.5% (<69 mmol/mol)– N (%) 1054 (84) 1488 (81) 3 (-1, 7) 0.03

SBP (mmHg) – Mean (standard deviation) 128 (16) 136 (17) -7 (-9, -5) <0.001

No Anti-hypertensive Use (mmHg) – Mean (standard deviation) 123 (13) 133 (16) -10 (-13, -6) <0.001

Anti-hypertensive Use (mmHg) – Mean (standard deviation) 129 (16) 137 (17) -7 (-9, -5) <0.001

DBP (mmHg) – Mean (standard deviation) 68 (9) 74 (9) -6 (-7, -5) <0.001

No Anti-hypertensive Use (mmHg) –Mean (standard deviation) 68 (9) 75 (9) -7 (-9, -5) <0.001

Anti-hypertensive Use (mmHg) – Mean (standard deviation) 68 (9) 74 (9) -6 (-7, -5) <0.001

≥140/80 – N (%) 336 (27) 1092 (57) -29 (-34, -25) <0.001

No Anti-hypertensive Use – N (%) 35 (21) 389 (55) -35 (-44, -25) <0.001

Anti-hypertensive Use – N (%) 250 (27) 703 (57) -29 (-34, -23) <0.001

≥140/85 – N (%) 277 (22) 844 (44) -21 (-25, -17) <0.001

No Anti-hypertensive Use – N (%) 24 (14) 280 (40) -25 (-34, -17) <0.001

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 Anti-hypertensive Use – N (%) 210 (23) 564 (46) -22 (-27, -16) <0.001

≥140/90 – N (%) 266 (21) 811 (42) -20 (-24, -15) <0.001

No Anti-hypertensive Use – N (%) 203 (22) 267 (38) -26 (-34, -17) <0.001

Anti-hypertensive Use – N (%) 20 (12) 544 (44) -21 (-26, -15) <0.001

Insulin Dose (u/kg) – Mean (standard deviation) 0.5 (0.3) 0.7 (0.4) -0.1 (-0.2, -0.1) <0.001

Pump Use (u/kg) – Mean (standard deviation) 0.5 (0.2) 0.8 (0.4) -0.2 (-0.3, -0.2) <0.001

Injections (u/kg) – Mean (standard deviation) 0.6 (0.3) 0.7 (0.3) -0.1 (-0.1, -0.04) <0.001

HDL (mmol/L) – Mean (standard deviation) 1.7 (0.5) 1.6 (0.5) 0.0 (0.0, 0.1) 0.18

No Statin Use (mmol/L) – Mean (standard deviation) 1.7 (0.6) 1.7 (0.6) 0.0 (0.0, 0.1) 0.21

Statin Use (mmol/L) – Mean (standard deviation) 1.6 (0.5) 1.6 (0.5) 0.1 (0.0, 0.1) 0.05

HDL (mg/dL) – Mean (standard deviation) 64 (21) 62 (21) 1 (-1, 3) 0.18

No Statin Use (mg/dL) – Mean (standard deviation) 67 (22) 64 (22) 2 (-2, 5) 0.21

Statin Use (mg/dL) – Mean (standard deviation) 62 (20) 60 (20) 2 (-1, 5) 0.05

LDL (mmol/L) – Mean (standard deviation) 2.2 (0.7) 2.8 (0.9) -0.65 (-0.74, -0.57) <0.001

No Statin Use (mmol/L) – Mean (standard deviation) 2.4 (0.8) 2.9 (0.9) -0.6 (-0.7, -0.5) <0.001

Statin Use (mmol/L) – Mean (standard deviation) 2.1 (0.7) 2.7 (0.9) -0.6 (-0.7, -0.5) <0.001

LDL (mg/dL) – Mean (standard deviation) 84 (28) 109 (35) -25 (-29, -22) <0.001

No Statin Use (mg/dL) – Mean (standard deviation) 91 (31) 114 (34) -23 (-29, -18) <0.001

Statin Use (mg/dL) – Mean (standard deviation) 80 (27) 103 (35) -23 (-27, -18) <0.001

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Serum Creatinine (mg/dL) – Mean (standard deviation) 1.1 (0.5) 1.2 (0.9) -0.1 (-0.2, -0.1) <0.001

eGFR MDRD (ml/min/1.73 m2)† – Mean (standard deviation) 67.9 (20.3) 65.6 (23.8) 0.8 (-1.4, 3.0) 0.35

<60 ml/min/1.73 m2 – N (%) 401 (33) 687 (39) -2 (-7, 3) 0.39

<30 ml/min/1.73 m2 – N (%) 41 (3) 133 (8) -4 (-6, -2) <0.001

eGFR CKD-EPI (ml/min/1.73 m2)† – Mean (standard deviation) 69.5 (19.2) 65.8 (22.4) 1.4 (-0.6, 3.5) 0.07

<60 ml/min/1.73 m2 – N (%) 366 (30) 648 (37) -1 (-6, 3) 0.43

<30 ml/min/1.73 m2 – N (%) 41 (3) 138 (8) -4 (-6, -2) <0.001

Retinopathy – N (%) 336 (34) 449 (40) -11 (-17, -5) <0.001

Urine albumin 30-300 mg/g Cr – N (%) 203 (17) 656 (44) -27 (-32, -22) <0.001

Urine albumin >300 mg/g Cr – N (%) 33 (3) 58 (4) -2 (-3, 0) 0.01

History of Stroke – N (%) 31 (2) 164 (8) -5 (-7, -3) <0.001

History of MI – N (%) 77 (6) 184 (9) -3 (-5, -1) <0.001

Neuropathy – N (%) 467 (36) 1412 (70) -35 (-40, -30) <0.001

Depression – N (%) 207 (16) 175 (8) 6 (3, 9) <0.001

*Adjusted for gender, age group, diabetes duration group and the interaction of age group and diabetes duration group.
†Formula validaƟon limited in those >70 years of age. All DPV participants analyzed as White/Caucasian.

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Table 3. Clinical Outcomes Comparison of T1DX and DPV by Age Group
60 to <70 Years ≥70 Years

T1DX DPV Adjusted* Adjusted* T1DX DPV Adjusted* Adjusted*

Difference Difference
N=935 N=937 P-Value N=348 N=1077 P-Value
(99% CI) (99% CI)

HbA1c (%, mmol/mol)– Mean (standard deviation) 7.5 (1.0) 7.6 (1.4) -0.1 (-0.2, 0.1) 0.15 7.4 (1.0) 7.5 (1.3) 0.0 (-0.2, 0.2) 0.67

58 (10.9) 60 (15.3) 57 (10.9) 58 (14.2)

<7.5% (<58 mmol/mol) – N (%) 457 (50) 461 (54) -5 (-11, 1) 0.04 178 (53) 593 (59) -8 (-16, 0) 0.01

<8.0% (<64 mmol/mol) – N (%) 647 (70) 583 (69) 1 (-5, 7) 0.66 246 (73) 720 (72) 0 (-8, 7) 0.87

<8.5% (<69 mmol/mol)– N (%) 764 (83) 671 (79) 3 (-2, 8) 0.08 290 (86) 817 (82) 3 (-3, 9) 0.21

SBP (mmHg) – Mean (standard deviation) 128 (16) 135 (16) -7 (-9, -5) <0.001 129 (17) 136 (18) -8 (-10, -5) <0.001

No Anti-hypertensive Use (mmHg) – Mean 123 (13) 133 (15) -10 (-14, -6) <0.001 126 (16) 134 (17) -8 (-16, -1) 0.005
(standard deviation)

Anti-hypertensive Use (mmHg) – Mean 129 (15) 136 (17) -7 (-9, -4) <0.001 129 (17) 137 (18) -8 (-11, -5) <0.001
(standard deviation)

DBP (mmHg) – Mean (standard deviation) 69 (9) 75 (9) -6 (-7, -5) <0.001 68 (9) 74 (9) -6 (-7, -4) <0.001

No Anti-hypertensive Use (mmHg) – Mean 69 (9) 75 (9) -6 (-9, -4) <0.001 66 (10) 74 (9) -8 (-12, -3) <0.001
(standard deviation)

Anti-hypertensive Use (mmHg) – Mean 68 (9) 75 (9) -6 (-7, -5) <0.001 68 (9) 73 (9) -5 (-7, -4) <0.001
(standard deviation)

≥140/80 – N (%) 240 (27) 502 (56) -29 (-35, -23) <0.001 96 (28) 590 (57) -29 (-36, -21) <0.001

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 No Anti-hypertensive Use – N (%) 26 (20) 212 (56) -35 (-47, -24) <0.001 9 (24) 177 (55) -32 (-51, -14) <0.001

Anti-hypertensive Use – N (%) 174 (27) 290 (56) -28 (-36, -21) <0.001 76 (29) 413 (58) -29 (-38, -20) <0.001

≥140/85 – N (%) 196 (22) 378 (42) -21 (-26, -15) <0.001 81 (24) 466 (45) -21 (-28, -14) <0.001

No Anti-hypertensive Use – N (%) 17 (13) 147 (39) -26 (-36, -16) <0.001 7 (18) 133 (41) -24 (-41, -6) <0.001

Anti-hypertensive Use – N (%) 145 (22) 231 (45) -21 (-29, -14) <0.001 65 (25) 333 (47) -22 (-30, -13) <0.001

≥140/90 – N (%) 186 (21) 354 (40) -19 (-25, -13) <0.001 80 (23) 457 (44) -21 (-28, -14) <0.001

No Anti-hypertensive Use – N (%) 13 (10) 137 (36) -26 (-35, -17) <0.001 7 (18) 130 (40) -23 (-40, -6) <0.001

Anti-hypertensive Use – N (%) 139 (22) 217 (42) -20 (-27, -13) <0.001 64 (24) 327 (46) -21 (-30, -13) <0.001

Insulin Dose (u/kg) – Mean (standard deviation) 0.5 (0.3) 0.7 (0.3) -0.1 (-0.2, -0.1) <0.001 0.5 (0.3) 0.7 (0.4) -0.1 (-0.2, -0.1) <0.001

Pump Use (u/kg) – Mean (standard deviation) 0.5 (0.2) 0.7 (0.4) -0.2 (-0.3, -0.2) <0.001 0.5 (0.2) 0.8 (0.5) -0.3 (-0.4, -0.2) <0.001

Injections (u/kg) – Mean (standard deviation) 0.6 (0.3) 0.7 (0.3) -0.1 (-0.1, -0.02) <0.001 0.6 (0.3) 0.7 (0.4) -0.1 (-0.2, 0.0) 0.005

HDL (mmol/L) – Mean (standard deviation) 1.7 (0.6) 1.6 (0.6) 0.0 (0.0, 0.1) 0.10 1.6 (0.5) 1.6 (0.5) 0.0 (-0.1, 0.1) 0.88

No Statin Use (mmol/L) – Mean (standard 1.8 (0.6) 1.7 (0.6) 0.1 (0.0, 0.2) 0.10 1.6 (0.6) 1.6 (0.5) 0.0 (-0.2, 0.1) 0.72
deviation)

Statin Use (mmol/L) – Mean (standard 1.6 (0.5) 1.6 (0.5) 0.1 (0.0, 0.2) 0.05 1.6 (0.5) 1.6 (0.5) 0.0 (-0.1, 0.1) 0.59
deviation)

HDL (mg/dL) – Mean (standard deviation) 65 (21) 63 (22) 2 (-1, 5) 0.10 61 (19) 62 (21) 0 (-4, 3) 0.88

No Statin Use (mg/dL) – Mean (standard 69 (22) 65 (23) 3 (-2, 7) 0.10 62 (21) 63 (21) -1 (-7, 5) 0.72
deviation)

Statin Use (mg/dL) – Mean (standard deviation) 63 (21) 60 (20) 3 (-1, 6) 0.05 61 (18) 61 (20) 1 (-3, 5) 0.59

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LDL (mmol/L) – Mean (standard deviation) 2.2 (0.8) 2.9 (0.9) -0.7 (-0.8, -0.6) <0.001 2.1 (0.7) 2.8 (0.9) -0.6 (-0.8, -0.5) <0.001

No Statin Use (mmol/L) – Mean (standard 2.9 (0.8) 3.0 (0.9) -0.7 (-0.8, -0.5) <0.001 2.4 (0.8) 2.9 (0.8) -0.5 (-0.7, -0.2) <0.001
deviation)

Statin Use (mmol/L) – Mean (standard 2.1 (0.7) 2.7 (0.9) -0.6 (-0.7, -0.4) <0.001 2.0 (0.6) 2.6 (0.9) -0.6 (-0.8, -0.4) <0.001
deviation)

LDL (mg/dL) – Mean (standard deviation) 85 (29) 112 (36) -26 (-31, -22) <0.001 82 (27) 107 (33) -24 (-29, -18) <0.001

No Statin Use (mg/dL) – Mean (standard 91 (31) 116 (36) -26 (-33, -19) <0.001 92 (32) 111 (32) -18 (-28, -9) <0.001
deviation)

Statin Use (mg/dL) – Mean (standard deviation) 82 (28) 105 (36) -23 (-29, -17) <0.001 77 (23) 101 (35) -23 (-29, -17) <0.001

Creatinine (mg/dL) – Mean (standard deviation) 1.0 (0.5) 1.2 (1.0) -0.2 (-0.3, -0.1) <0.001 1.1 (0.5) 1.2 (0.7) -0.1 (-0.2, 0.0) 0.02

eGFR MDRD (ml/min/1.73 m2)† – Mean (standard 69.6 70.5 0.5 (-2.3, 3.3) 0.62 63.1 61.7 1.3 (-2.2, 4.8) 0.34
deviation) (20.4) (24.6) (19.3) (22.4)

<60 ml/min/1.73 m2 – N (%) 243 (28) 226 (29) -3 (-9, 3) 0.17 158 (48) 461 (48) 0 (-8, 9) 0.89

<30 ml/min/1.73 m2 – N (%) 29 (3) 54 (7) -3 (-6, -1) <0.001 12 (4) 79 (8) -4 (-7, -1) 0.001

eGFR CKD-EPI (ml/min/1.73 m2)† – Mean (standard 72.1 72.1 1.2 (-1.4, 3.8) 0.23 62.5 60.7 1.8 (-1.4, 5.1) 0.15
deviation) (19.1) (22.9) (17.7) (20.6)

<60 ml/min/1.73 m2 – N (%) 214 (24) 190 (24) -2 (-7, 4) 0.43 152 (46) 458 (47) -1 (-9, 7) 0.72

<30 ml/min/1.73 m2 – N (%) 29 (3) 54 (7) -3 (-6, -1) <0.001 12 (4) 84 (9) -5 (-8, -1) <0.001

Retinopathy (any) – N (%) 237 (32) 201 (38) -12 (-20, -5) <0.001 99 (37) 248 (42) -10 (-19, 0) 0.01

Urine albumin 30-300 mg/g Cr – N (%) 142 (16) 284 (43) -28 (-34, -22) <0.001 61 (19) 372 (45) -26 (-33, -19) <0.001

Urine albumin >300 mg/g Cr – N (%) 24 (3) 36 (6) -3 (-5, -1) 0.001 9 (3) 22 (3) 0 (-3, 2) 0.99

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History of Stroke – N (%) 19 (2) 58 (6) -4 (-6, -2) <0.001 12 (3) 106 (10) -6 (-10, -3) <0.001

History of MI – N (%) 52 (6) 81 (9) -3 (-6, -1) 0.002 25 (7) 103 (10) -2 (-6, 1) 0.10

Neuropathy – N (%) 333 (36) 662 (71) -37 (-43, -31) <0.001 134 (39) 750 (70) -31 (-39, -24) <0.001

Depression – N (%) 159 (17) 95 (10) 6 (2, 10) <0.001 48 (14) 80 (7) 6 (1, 11) 0.001

*Adjusted for gender and diabetes duration.

†Formula validaƟon limited in those >70 years of age. All DPV parƟcipants analyzed as White/Caucasian.

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Table 4. Clinical Outcomes Comparison of T1DX and DPV by Estimated GFR

≥60 (ml/min/1.73 m2) 30 to <60 (ml/min/1.73 m2) <30 (ml/min/1.73 m2)

T1DX DPV Adjusted* Adjusted* T1DX DPV Adjusted* Adjusted* T1DX DPV Adjusted* Adjusted*
Difference Difference Difference
(N=803) (N=1067) P-Value (N=306) (N=554) P-Value (N=120) (N=393) P-Value
(99% CI) (99% CI) (99% CI)

Retinopathy 165 216 (35) -11 (-18, -5) <0.001 134 138 -2 (-13, 9) 0.72 37 (40) 95 (45) -7 (-25, 10) 0.26
(any) – N (%) (27) (46) (46)

Urine albumin 81 (11) 334 (39) -29 (-34, - <0.001 90 (27) 223 -22 (-31, - <0.001 32 (36) 99 (55) -20 (-37, -2) 0.003
30-300 mg/g 23) (50) 13)
Cr– N (%)

Urine albumin 4 (1) 15 (2) -1 (-3, 1) 0.13 16 (5) 11 (2) 1 (-2, 5) 0.29 13 (15) 32 (18) -2 (-13, 8) 0.54
>300 mg/g Cr –
N (%)

History of 14 (2) 78 (7) -6 (-10, -1) 0.001 12 (3) 57 (10) -6 (-10, -1) 0.002 5 (4) 29 (7) -2 (-8, 4) 0.44
Stroke – N (%)

History of MI – 38 (5) 69 (6) -2 (-6, 1) 0.08 28 (8) 70 (13) -4 (-11, 2) 0.10 11 (9) 45 (11) -2 (-12, 9) 0.72
N (%)

Neuropathy – N 261 766 (72) -40 (-46, - <0.001 153 370 -24 (-32, - <0.001 53 (44) 276 -25 (-39, - <0.001
(%) (33) 35) (43) (67) 15) (70) 12)

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Figure 1A. Prevalence of renal disease in the T1D Exchange and DPV registries

Figure Legend
Solid white bar= urine albumin 30-300 mg/g Cr (microalbuminuria)*
Solid black bar= urine albumin >300 mg/g Cr (macroalbuninuria)†

Figure 1B. Glomerular Filtration Rate in the T1D Exchange and DPV registries

Figure Legend
Solid white bar= <60 ml/min/1.732
Solid black bar= <30 ml/min/1.732

Figure 1C. Stroke and myocardial infarction in the T1D Exchange and DPV registries

Figure Legend
Solid white bar= T1D Exchange registry
Solid black bar= DPV registry

DRAFT

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DRAFT

Document1 Page 28 of 29
Highlights

• Cross-sectional study of adults ≥60 years old with type 1 diabetes mellitus seen in 2011-2012 in
the U.S. T1D Exchange and German/Austrian DPV registries.
• Individuals in both registries were similar in body mass index, percent with obesity, and gender.
• Differences between the registries included greater use of antihypertensives, statins and insulin
pumps, and fewer chronic complications in the T1D Exchange.
• Further research is needed to better understand the role of intensive therapy in improving
outcomes in older adults with type 1 diabetes mellitus.

DRAFT

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