Case Studies

How T1D Exchange is improving T1D outcomes

Needle­free glucagon: a partnership with Locemia Solutions

In type 1 diabetes (T1D), a severe low can cause confusion, seizures, or unconsciousness. It requires medical intervention right away from someone other than the person with T1D. It might be a spouse, parent, or friend. It can be a teacher, coach or babysitter—most often, it’s from someone who has no medical training.

The life­saving hypoglycemia rescue kit is complex. It contains a powdered form of glucagon that needs to be:

  • reconstituted into a liquid,
  • drawn into a needle
  • and injected in the person’s thigh

No easy task under the best of circumstances—and certainly not while a loved one or friend is seizing or unconscious.

Putting the power of T1D Exchange to work

In 2013, T1D Exchange partnered with a small biotechnology company, Locemia Solutions, to accelerate a new approach to treating severe hypoglycemic events with new glucagon therapy.

T1D Exchange started by asking the Glu community a Question of the Day about the complexities of using injectable rescue glucagon. Our community’s real­world experiences helped Locemia Solutions define the challenges of injectable glucagon in discussions with the FDA – which ultimately greenlighted clinical studies of an intranasal form of glucagon.

T1D Exchange then put its incredible resources to work. We:

  • partnered in designing clinical protocols and conducted two multi­site clinical studies
  • leveraged our Clinic Network with highly qualified clinical investigators to conduct the studies
  • and recruited T1D registry members to participate in the clinical studies.

The Results

Developing a new therapy like intranasal glucagon and getting it FDA­-approved can take many years—and even so, might never reach FDA approval. By using the power of T1D Exchange, intranasal glucagon has sped through phase 3 clinical trials in less than one year. All told, with the help of the Glu community, our clinical team and the dedication of Locemia Solutions and funding partner The Leona M. and Harry B. Helmsley Charitable Trust, needle ­free glucagon could become a reality in less than 3 years!

T​1D Exchange: Widely published, widely respected

T1D Exchange performs real­ world patient­-driven research through its Clinic Registry, its Clinic Network and through Glu.

Our research has driven a wealth of important findings that have been shared via scientific poster sessions and conference presentations, and have been published in diabetes and other peer­-reviewed medical and scientific journals.

Why does this matter?
Sharing findings through presentations and publishing:

  • Informs the medical community about the needs of individuals with T1D
  • Drives new programs aimed at improving T1D care and health outcomes
  • Presents unmet needs that require further studies
  • Presents opportunities for future research collaborations
  • Provides evidence­-based research to support initiatives that may lead to better access and affordability of treatments

In just a few short years, T1D Exchange has become a widely­-recognized resource for important quality research, presenting or publishing:

  • nearly 60 meeting abstracts
  • 18 manuscripts, (with more than 10 manuscripts readying for publication)

Here are some key findings from T1D Exchange:

  • Most adults and children with T1D do not achieve goals for glucose control set by the American Diabetes Association.
  • Both children and adults who are under excellent glycemic control tend to manage their diabetes differently than those who are under poorer control. These management aspects include decisions on how much insulin to take, when insulin boluses are given, frequency of blood glucose monitoring, and exercise.
  • Racial and socio­-economic disparities exist in use of insulin pumps and in glucose control. The clinic registry data show that pump use is much more frequent in Whites than African Americans or Hispanics, a relationship which persists even after adjusting for socio­economic status. In addition, African Americans have higher HbA1c levels than Hispanics or Whites in both pump and injection users.
  • The frequency of home glucose monitoring is strongly associated with better diabetes control as measured with HbA1c. This information has been used to help support insurance coverage for test strips in the state of Washington.
  • Continuous glucose monitoring (CGM) is being used by only a small percentage of individuals with T1D, based on the clinic registry data, even though substantial benefit has been shown when CGM is used regularly. T1D Exchange data show that HbA1c levels are lower in those using CGM versus not using CGM.

Explore more findings from T1D Exchange

T1D Exchange – collaborating globally means better outcomes everywhere

While T1D Exchange is leading a range of translational, observational and interventional studies, each study relates to one goal – to improve the quality of life for people with type 1 diabetes. To achieve this goal, T1D Exchange seeks collaboration with others in the global research community. To date, T1D Exchange has completed a number of studies with other countries, including Germany/Austria, the UK and Australia.

Here are results from some recent collaborations.

DKA in pediatric patients with type 1
In the largest multinational analysis of diabetic ketoacidosis (DKA) in pediatric type 1 diabetes patients, T1D Exchange researchers found consistently high rates and common risk factors for DKA across five countries, confirming that DKA—a largely preventable condition—remains a serious threat for type 1 diabetes patients. The analysis also highlights the considerable costs associated with treating DKA, which creates a serious financial burden for healthcare systems, patients, and families.

According to the research, the frequency of DKA ranged from five to seven percent of pediatric patients diagnosed and treated each year across the three registries, or:

  • One in 14 in the U.S. (T1D Exchange Clinic Registry);
  • One in 16 in England and Wales (NPDA); and
  • One in 20 in Germany and Austria (DPV).

Patients in all three registries also exhibited common risk factors for DKA diagnosis.

See more findings from this research.

Obesity in children with type 1

Adolescents with type 1 diabetes have not escaped the global obesity epidemic and those in the U.S. are significantly more overweight than their German and Austrian counterparts. The findings are especially concerning as excessive weight puts adolescents with type 1 diabetes at higher risk for insulin resistance, severe hypoglycemia and cardiovascular disease, which is the leading cause of death for type 1 diabetes patients.

Researchers examined height and weight data of nearly 33,000 pediatric type 1 diabetes patients ages two through 18 via the T1D Exchange Clinic Registry (comprising more than 27,000 patients from 76 endocrinology centers in the US) and the Diabetes Prospective Follow­up (DPV) registry, a database with more than 40,000 patients from 209 centers in Germany and Austria.

Nearly 40 percent of children in both registries were considered obese or overweight. However, children in the T1D Exchange Clinic Registry were more obese than those in the DPV (15 percent compared with 10 percent).

See more findings from this research.

Study Finds Insulin Pump Use by Multinational Children Varies; Minorities Less Likely Than Peers

A recent collaboration found that the use of insulin pumps by children varies greatly between the United States, England/Wales, and Austria/Germany, but in all three regions, minority children are less likely to use pumps to treat type 1 diabetes (T1D).

Using data from T1D Exchange Clinic Registry (United States), the National Pediatric Diabetes Audit (England and Wales) and the DPV Registry (Austria/Germany), a group of researchers analyzed 54,767 children and adolescents under 18 years of age with T1D to examine how many of these patients were currently using insulin pump therapy.

In all three registries, minority children were less likely to use insulin pump therapy than their non­minority T1D peers. Overall, 22.4% of minority children compared with 34.7% of non­-minority children used a pump. Among each individual registry, similar results were found: in T1D Exchange, the difference was 29.3 minority vs. 50.6% non­minority; DPV: 30.9% minority vs. 41.9% non­-minority; and UK: 8.1% minority vs. 14.8% non­-minority.

See more findings from this research.

Better clinical outcomes in older adults

A multinational study to compare patient characteristics and treatment­-related factors associated with better clinical outcomes in older adults was conducted using T1D Exchange and German/Austrian Diabetes (DPV) registries. Data analyzed from adults aged ≥60 years with type 1 diabetes highlighted differences in certain aspects of diabetes management and diabetes complications. Further assessments are needed to better understand the differences to determine if aspects of care can be modified to improve outcomes.

This study analyzed the following (T1D Exchange compared with the DPV):

  • HbA1c levels
  • Self­-monitoring of blood glucose
  • Use of insulin pumps
  • Use of continuous glucose monitoring
  • Episodes of diabetic ketoacidosis

Children under 6 in US have higher A1C levels than when compared to those in Germany/Austria

Increased Insulin Pump Use Linked to Lower A1c in Young Children with Type 1 Diabetes: Researchers from the T1D Exchange in the United States and the DPV registry in Germany/Austria teamed up to analyze whether or not children with type 1 diabetes under six years old are achieving A1c levels less than 7.5 percent as recommended by the International Society for Pediatric and Adolescent Diabetes.

The study found that patients in the DPV were able to achieve lower A1c levels, with a higher proportion reaching the International Society for Pediatric and Adolescent Diabetes target and less severe hypoglycemia than in the T1DX registry. Increased use of insulin pumps in the DPV cohort appears to be an important factor in differences in treatment outcomes between these two groups.

Researchers studied clinical characteristics and modes of treatment and treatment outcomes in their respective registry databases in all patients less than six years of age with at least one year of type 1 diabetes (T1D).

Young children in both registries had similar clinical characteristics with respect to age, gender, and T1D duration. In addition, total daily insulin dose and frequency of self­-monitoring of blood glucose were nearly identical in both groups. However, researchers found that mean A1c and severe hypoglycemia were higher in the T1DX patients, and that the percentage of those with A1c less than the recommended 7.5 percent was lower than the DPV patients.

At the same time, researchers found that only 49 percent of T1DX patients versus 77 percent of DPV patients were being treated with insulin­pump therapy. And, within the T1DX cohort, A1c levels were lower in pump (7.9 percent) than in injection patients (8.5 percent).