Treatment outcomes in type 1 diabetes could be improved across all age groups

In a sweeping analysis assessing the current state of diabetes treatment in the U.S., T1D Exchange researchers conclude that there remains considerable room for improving treatment outcomes in type 1 diabetes across all age groups, but especially for adolescents and young adults. The analysis provides the most up-to-date picture of diabetes treatment, underscoring the need to address barriers to care and implement new therapies and technologies that can help type 1 patients achieve optimal metabolic control.

The findings, published today in a special issue of Diabetes Care, come from data collected by the T1D Exchange Clinic Registry. Researchers from the Exchange evaluated data from more than 16,000 patients ages two to 95. Data were collected twice: between September 2010 to August 2012 and again, from September 2013 to December 2014. A key area of study was glycemic control across the age spectrum, determined by examining Hemoglobin A1c (HbA1c) levels, a standard test of average blood sugar levels over two to three months. According to the American Diabetes Association, the recommended target A1c level is less than 7 percent for adults with type 1 diabetes and less than 7.5 percent for youth under the age of 19.

Researchers found that while 8.4 percent remains the average A1c level across the Registry, A1c levels are notably worse among 13 to 25-year olds. In fact, A1c levels for 13 to 17-year olds have barely changed since the initial Diabetes Control and Complications Trial (DCCT) results published in 1992. Specifically:

• Adolescents in the Registry averaged a 9.0 percent A1c compared with the 9.5 percent registered by the same age group during the DCCT, indicating that advances in diabetes management over the past two decades have been less successful in overcoming the special challenges in managing teenagers with the disease.
• The majority of young adults in their 20s do not fully achieve glycemic control until they are 30. Only 14 percent of registrants between 18 and 25-years old met the recommended 7 percent A1c level compared with 30 percent of older adults.

"While disease management at every age needs to improve, it's especially disconcerting how poorly we continue to manage type 1 diabetes in adolescents," says Kellee Miller, Assistant Director, Epidemiologist, Statistician, Jaeb Center for Health Research. "This age group in particular faces unique challenges to diabetes management, including hormone fluctuations that affect blood sugar control, the sometimes overwhelming demands of diabetes self-care and even phases of rebelling against parents and physicians, which may lead to complications treating their disease."

According to the researchers, it is imperative to provide greater access to technologies such as continuous glucose monitors (CGM) and insulin pumps, and to advance better treatment options such as the artificial pancreas, smarter insulins and non-insulin therapies. Such advances would likely help increase glycemic control for the majority of type 1 diabetes patients.

"Our data show that while advances have been made in type 1 diabetes, the condition remains a tremendous burden, particularly in youth," said Dana Ball, executive director and co-founder of the Exchange. "This only furthers our resolve to accelerate the research that is going to reduce burden of living with type 1 and improve outcomes."

Approximately 35 million people worldwide are living with type 1 diabetes, and over 30,000 new patients will be diagnosed this year in the U.S. alone. Type 1 diabetes accounts for about five to 10 percent of all diabetes cases and results from an immune-mediated destruction of insulin-producing pancreatic beta cells.

Insight Into Managing Diabetes Through Medications and Advanced Technologies
In addition to studying glycemic control, researchers assessed use of advanced diabetes technologies, insulin and other glucose-lowering agents. They found:

• Insulin pumps are used by 60 percent of registrants, with the largest increase in pump use among pediatric patients (approximately 65 percent of patients six to 12-years old use an insulin pump). Pump use did not change among 18 to 25-year olds (55 percent) and increased only slightly in older adults.
• Across all age groups, the use of continuous glucose monitoring (CGM) is low but increasing; the lowest rate being among pediatric patients.
• Use of glucose-lowering agents in addition to insulin treatment was uncommon across all age groups. Metformin was the most common noninsulin glucose-lowering drug being used but only by 6% of those >/=26 years old. No other noninsulin drug was being used by more than 2% of those >/=26 years of age or by more than 1% of younger participants.

Researchers also analyzed responses from a subset of 2,561 registrants who completed a questionnaire on severe hypoglycemia and diabetic ketoacidosis (DKA, in which the body produces excess blood acids, which can lead to diabetic coma or even death). Findings included:

• Six percent of patients reported having a seizure or loss of consciousness due to severe hypoglycemia in the three months previous to completing the participant questionnaire, with the highest occurrence among those 50 years or older. Insulin pump use was associated with a lower frequency of severe hypoglycemia (SH).
• Three percent reported the occurrence of diabetic ketoacidosis at least once in the three months previous to completing the participant questionnaire, with the highest occurrence among adolescents and young adults.
• The frequency of diabetic ketoacidosis tended to be greater among participants with higher A1c levels and slightly lower among participants using an insulin pump.

"Analysis of the clinic registry data reveals that high proportions of individuals are simply not achieving glycemic targets with current therapies. This only sharpens our focus for the absolute need for the development and dissemination of an artificial pancreas, safe and effective islet replacement, development of smarter insulins and non-insulin therapies, and rigorous quality improvement in clinical care," says Henry Anhalt, DO, and chief medical officer at T1D Exchange. "The T1D Exchange model fosters collaboration to accelerate real-world research, and this analysis is an example of how patient participation allows researchers to study in near real-time the challenges and realities the type 1 community faces each day, so that we can determine where to focus our efforts in order to achieve better outcomes."

A Breakthrough Approach to Advancing Research and Treatment for Type 1 Diabetes
The T1D Exchange was founded in 2009 with the express goal of removing barriers and inefficiencies for clinical and translational research to accelerate discoveries and delivery of new treatments. The Exchange has built an active type 1 diabetes community that engages patients, clinicians, researchers, and industry to advance research that will ultimately lead to better health and quality of life for people living with type 1 diabetes.

At the heart of the T1D Exchange "ecosystem" is a patient-centered model composed of integrated elements: the well-characterized Clinic Registry comprised of more than 26,000 individuals with type 1 diabetes patients; a Clinic Network of 250 investigators at over 75 sites who follow 150,000 patients; a Biobank, a repository of thousands of patient biosamples; a Living Biobank comprised of participants who have agreed to be contacted for biosamples as needed by the research community; and Glu, an active online community of 13,000 patients and caregivers.

The study was funded by The Leona M. and Harry B. Helmsley Charitable Trust, the largest private funder of T1D-related research, treatment and support programs in the nation.

SOURCE T1D Exchange