Results Demonstrate Enhanced Diabetes
Management and Quality of Life with Advanced Technology
ORLANDO,
Fla., June 24, 2024 /PRNewswire/ -- New
data focused on advanced technology innovations for managing type 2
diabetes (T2D) highlight the positive impact of automated insulin
delivery systems (AID) and continuous glucose monitoring (CGM) in
improving glycemic control and overall diabetes management. Three
studies showing advancements for type 2 diabetes were presented at
the American Diabetes Association's ® (ADA) 84th Scientific
Sessions in Orlando, FL.
Of the nearly 40 million Americans with diabetes, more than 90%
have type 2 diabetes. As the prevalence continues to rise globally,
effective management strategies are more critical than ever. The
studies showcased at the ADA Scientific Sessions emphasize the
transformative potential of integrating advanced technologies into
diabetes care, particularly for under-resourced populations.
"These studies represent a significant advancement in diabetes
management technologies, showing substantial improvements in
glycemic control and quality of life for people with type 2
diabetes," said Robert Gabbay, MD,
PhD, ADA chief scientific and medical officer. "By leveraging these
innovations, we can empower patients with more effective and
manageable treatment options, ultimately transforming the landscape
of diabetes care."
SECURE-T2D Pivotal Trial Demonstrates Significant Benefits of
Omnipod® 5 Automated Insulin Delivery System in Adults with Type 2
Diabetes
Findings from the SECURE-T2D pivotal trial, the first
large-scale, multicenter study evaluating the Omnipod® 5 AID
System, a novel insulin pump, in a racially diverse group of adults
with type 2 diabetes were presented as a late-breaking poster.
The Omnipod 5 AID System is a tubeless insulin pump that
automatically adjusts insulin delivery based on CGM data. This
system aims to improve glycemic control by responding to glucose
levels in real-time, reducing the burden of manual insulin dosing
for people with diabetes.
The multicenter pivotal clinical trial included 305 adults aged
18-75 years with type 2 diabetes who were using various insulin
regimens (basal-bolus, premix, or basal-only) and had a baseline
HbA1c of less than 12.0%. After a 14-day standard therapy phase to
establish baseline glycemic control, participants transitioned to
13 weeks of using the Omnipod 5 AID System. The primary endpoint
was the change in HbA1c from baseline to 13 weeks. The study
population was also notably diverse, with 24% Black and 22%
Hispanic/Latino participants.
Key findings from the trial showed that the use of the Omnipod®
5 AID System led to a significant reduction in HbA1c levels, from a
baseline average of 8.2±1.3% to 7.4±0.9% at the end of the study
(treatment effect: -0.8%, 95% CI: -1.0 to -0.7, p<0.001). The
greatest improvements were observed in participants with the
highest baseline HbA1c.
"The results from the SECURE-T2D trial underscore the potential
of the Omnipod 5 AID System to transform diabetes management for
adults with type 2 diabetes," said Francisco J. Pasquel, MD, MPH, Associate
Professor of Medicine and Global Health at Emory University, and lead author of the study.
"The substantial improvements in glycemic control and quality of
life, particularly among minority populations, are promising steps
toward more equitable diabetes care."
Future research will focus on long-term outcomes and the
potential of a new solution to address other aspects of diabetes
management. The authors also note that studies may explore its
effectiveness in different populations and its impact on quality of
life for people with type 2 diabetes. Additionally, ongoing
analyses will aim to refine and enhance the system's algorithms to
maximize its benefits for users.
Improved Glycemic Outcomes with Continuous Glucose Monitoring
(CGM) in Type 2 Diabetes Patients: Real-World Analysis Reveals
Significant Benefits
Findings from an oral presentation, Glycemic Outcomes with
CGM Use in Patients with Type 2 Diabetes—Real-World Analysis,
showcase the significant impact of continuous glucose monitoring on
patients with type 2 diabetes, revealing the use of CGM
substantially improves glucose control in type 2 diabetes patients
across all therapeutic treatments.
The study evaluated the impact of CGM on adults with type 2
diabetes using non-insulin therapies (NIT), basal insulin (BIT),
and prandial insulin (PIT). This 12-month retrospective analysis
used data from a large claims database of over 7.1 million type 2
diabetes patients and compared HbA1c levels before and after CGM
use, focusing on the change closest to 12 months post-CGM
acquisition.
Among the 6,030 adults with type 2 diabetes (NIT: 1,533; BIT:
1,375; PIT: 3,122), with a mean baseline HbA1c of 8.8% and a mean
age of 59 years, significant HbA1c improvements (by 1% across all
therapies) were observed across all therapy groups after 12 months.
The study underscores CGM's potential to enhance glycemic control
and reduce healthcare costs in both insulin and non-insulin-treated
type 2 diabetes patients.
"These results suggest that CGM can play a crucial role in
enhancing health outcomes for all diabetes patients, regardless of
their treatment regimen," said Satish K.
Garg, MD, University of Colorado
Denver, and lead author of the study. "The real-world
analysis underscores the potential of CGM to not only improve
glycemic outcomes but also reduce healthcare resource utilization
and overall healthcare costs."
Looking ahead, longer-term studies and randomized controlled
trials are recommended to further validate these results and
explore the broader implications of CGM use in diabetes care.
Future research will focus on confirming the sustained benefits of
CGM and understanding its impact on various patient subgroups to
tailor diabetes management strategies effectively.
Using the same database, findings from a related late-breaking
abstract reveal that CGM use in type 2 diabetes results in more
than a 50% reduction in all-cause hospitalizations and acute
diabetes-related hospitalizations. Dr. Garg presented the results
of the late-breaking abstract, Impact of Continuous Glucose
Monitoring Use on Hospitalizations in People with Type 2
Diabetes—Real-World Analysis, as an e-theatre poster on
Sunday, June 23, 2024.
Continuous Glucose Monitoring (CGM) Improves Glycemic Control
in Adults with Type 2 Diabetes Not Using Insulin
Findings from a new study demonstrate that CGM significantly
enhances glycemic control in adults with type 2 diabetes who are
not using insulin. These results, presented during the general
poster session and simultaneously published in Diabetes
Technology and Therapeutics, underscore the potential of CGM to
improve diabetes management and support expanding CGM access for
adults with type 2 diabetes not using insulin.
The real-world study analyzed data from over 3,800 adults using
Dexcom G6 and G7 sensors. The participants, initially not meeting
their glycemic targets, showed significant improvements after six
months of CGM use, with further progress at one year.
Key findings include a 0.5% reduction in the glucose management
indictor, a CGM approximation of A1C, and a 17% increase in Time in
Range (TIR), which translates to an additional four hours per day
spent within the target glucose range. The study also highlighted
the advantages of the Dexcom High Alert feature, which notifies
users when glucose levels exceed their selected targets.
Participants who used this feature showed the greatest improvements
in their glucose levels. The consistent CGM use over the year
suggests sustained benefits and a positive impact on long-term
diabetes care.
"We are encouraged by the significant long-term improvements in
glycemic control observed in our study," said Jennifer E. Layne, PhD, Dexcom. "These findings
highlight the importance of CGM for managing non-insulin treated
type 2 diabetes for clinicians and for patient
self-management."
Looking ahead, the authors plan to continue studying this cohort
and other CGM users not taking insulin to explore ongoing patterns
of glycemic improvement and real-world behavior change enabled by
CGM. The team also intends to evaluate the impact of other Dexcom
system features on glycemic control.
Research presentation details:
Dr. Pasquel will present the findings at the late-breaking
poster session presentation sessions:
- Glycemic Improvement with Use of the Omnipod 5 Automated
Insulin Delivery System in Adults with Type 2 Diabetes—Results of
the SECURE-T2D Pivotal Trial
- Presented on Saturday, June 22,
2024 at 12:30 PM EDT
- ePoster Theater - Type 2 Diabetes—Prevention, Treatment, and
Technology
- Presented on Sunday, June 23,
2024 at 1:50 PM EDT
Dr. Garg will present the findings at the following oral
presentation session:
- Oral Presentations - New Technology—Continuous Glucose
Monitoring
- Glycemic Outcomes with CGM Use in Patients with Type 2
Diabetes—Real-World Analysis
- Presented on Monday, June 24,
2024 at 8:00 AM EDT
Dr. Layne will present the findings at the general poster
session:
- Long-Term Improvement in CGM-Measured Glycemic Control in
Adults with Type 2 Diabetes Not Treated with
Insulin—Real-Word
- Presented on Saturday, June 22,
2024 at 12:30 PM EDT
About the ADA's Scientific Sessions
The ADA's 84th Scientific Sessions, the world's largest
scientific meeting focused on diabetes research, prevention, and
care, will be held in Orlando, FL
on June 21-24. More than 11,000
leading physicians, scientists, and health care professionals from
around the world are expected to convene both in person and
virtually to unveil cutting-edge research, treatment
recommendations, and advances toward a cure for diabetes. Attendees
will receive exclusive access to thousands of original research
presentations and take part in provocative and engaging exchanges
with leading diabetes experts. Join the Scientific Sessions
conversation on social media using
#ADAScientificSessions.
About the American Diabetes Association
The American Diabetes Association (ADA) is the nation's leading
voluntary health organization fighting to bend the curve on the
diabetes epidemic and help people living with diabetes thrive. For
83 years, the ADA has driven discovery and research to treat,
manage, and prevent diabetes while working relentlessly for a cure.
Through advocacy, program development, and education we aim to
improve the quality of life for the over 136 million Americans
living with diabetes or prediabetes. Diabetes has brought us
together. What we do next will make us Connected for Life®. To
learn more or to get involved, visit us
at diabetes.org or call 1-800-DIABETES (1-800-342-2383).
Join the fight with us on Facebook (American Diabetes Association),
Spanish Facebook (Asociación Americana de la Diabetes), LinkedIn
(American Diabetes Association), Twitter (@AmDiabetesAssn), and
Instagram (@AmDiabetesAssn).
Contact:
Amy Robinson
arobinson@brgcommunications.com
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SOURCE American Diabetes Association