ORLANDO, Fla., June 23, 2018 /PRNewswire-USNewswire/ -- New
research finds that people with type 1 diabetes (T1D) who used the
Diabeloop DBLG1 therapeutic, closed-loop insulin delivery system in
a home setting experienced a greater percentage of time in the
target blood glucose range and fewer hypoglycemic events compared
to patients who used an open-loop system, consisting of their
regular pump and sensor. The findings from the study, "Twelve-Week
Home Use of Hybrid Closed-Loop Insulin Delivery System vs.
Sensor-Assisted Pump Therapy in Adults with Type 1
Diabetes—Intermediate Results of the Multicenter Randomized
Crossover Diabeloop WP7 Trial," were presented today at the
American Diabetes Association's® (ADA's) 78th Scientific
Sessions® at the Orange County Convention
Center Convention Center.
The Diabeloop DBLG1 system is an advanced, closed-loop insulin
delivery system with a complex, customizable algorithm that
predicts future blood glucose levels and instructs insulin delivery
by connecting three devices: a glucose sensor, a patch insulin pump
and a smartphone-like terminal device hosting the algorithm. The
continuous glucose sensor monitors the user's blood glucose level
and sends data to the terminal, integrating the algorithm. The
terminal controls the connected insulin pump by calculating and
ordering the optimal amount of insulin. For maximum accuracy, users
enter their food and physical activity information.
The goal of this new study, a follow-up to a 2016, three-day
study, was to assess whether patients using the DBLG1 system could
achieve better glucose control compared to sensor-assisted pump
therapy in a home setting. The trial was conducted at 12 centers in
France and enrolled 68 adults
(average age 47.2 years) with T1D and an average HbA1c level of
7.6. The patients were randomly assigned to two groups, with 33
patients using the DBLG1 system, and 35 patients using their
normal, open-loop system (i.e., their usual pump and sensor). The
study was a crossover trial in which both groups of patients were
evaluated using the DBLG1 system for 12 weeks. This study details
the results of the first 12-week timeframe.
The results showed that the percentage of time spent in the
target blood glucose range of 70-180 mg/dl was 69.3 percent for
patients using the DBLG1 system compared to 56.6 percent for
patients using an open-loop system. While the average glycemic
level was lower for patients with the DBLG1 system compared to the
one for patients with standard care, the lowered glucose level did
not lead to more hypoglycemic events. The percentage of time spent
in hypoglycemia (< 70 mg/dl) was about half the amount with the
DBLG1 than with the usual, open-loop system (2 percent and 4.5
percent, respectively).
"The DBLG1 is a powerful and customizable algorithm system for
type 1 diabetes treatment that may enable patients to significantly
and durably reduce their glucose levels without an increase in
hypoglycemic events," said lead study author Sylvia Franc, MD, research director and
vice-president of CERITD—Centre of Study and Research on
Intensification of Treatment of Diabetes—in France. "The results of our study confirm in
real life, over a 12-week period, the positive results previously
observed in an inpatient setting. This system has the potential to
substantially improve the glycemic control and the quality of life
for patients with type 1 diabetes, decrease long-term chronic
diabetes complications, and reduce the burden of the dozens of
daily calculations and therapeutic decisions they currently have to
make themselves."
To speak with Dr. Franc, please contact the ADA Press Office
on-site at the Orange County
Convention Center on June 22 - 26, by
phone at 407-685-4010 or by email at press@diabetes.org.
The American Diabetes Association's 78th Scientific Sessions, to
be held June 22-26, 2018, at the
Orange County Convention Center in
Orlando, is the world's largest
scientific meeting focused on diabetes research, prevention and
care. During the five-day meeting, more than 16,000 health care
professionals from around the world will have exclusive access to
more than 3,000 original diabetes research presentations,
participate in provocative and engaging exchanges with leading
diabetes experts, and can earn Continuing Medical Education (CME)
or Continuing Education (CE) credits for educational sessions. The
program is grouped into eight theme areas: Acute and Chronic
Complications; Behavioral Medicine, Clinical Nutrition, Education
and Exercise; Clinical Diabetes/Therapeutics;
Epidemiology/Genetics; Immunology/Transplantation; Insulin
Action/Molecular Metabolism; Integrated Physiology/Obesity; and
Islet Biology/Insulin Secretion. Felicia
Hill-Briggs, PhD, ABPP, President of Health Care and
Education, will deliver her address, "The American Diabetes
Association in the Era of Health Care Transformation," on
Saturday, June 23, and Jane E.B. Reusch, MD, President of Medicine and
Science, will present her address, "24/7/365 – Lifetime with
Diabetes," on Sunday, June 24. In
total, the 2018 Scientific Sessions includes 375 oral
presentations; 2,117 poster presentations, including 47 moderated
poster discussions; and 297 published-only abstracts. Join the
Scientific Sessions conversation on social media using
#2018ADA.
About the American Diabetes Association
Nearly half of
American adults have diabetes or prediabetes; more than 30 million
adults and children have diabetes; and every 21 seconds, another
individual is diagnosed with diabetes in the U.S. Founded in 1940,
the American Diabetes Association (ADA) is the nation's leading
voluntary health organization whose mission is to prevent and cure
diabetes, and to improve the lives of all people affected by
diabetes. The ADA drives discovery by funding research to treat,
manage and prevent all types of diabetes, as well as to search for
cures; raises voice to the urgency of the diabetes epidemic; and
works to safeguard policies and programs that protect people with
diabetes. In addition, the ADA supports people living with
diabetes, those at risk of developing diabetes, and the health care
professionals who serve them through information and programs that
can improve health outcomes and quality of life. For more
information, please call the ADA at 1-800-DIABETES (1-800-342-2383)
or visit diabetes.org. Information from both of these sources is
available in English and Spanish. Find us on Facebook (American
Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram
(@AmDiabetesAssn).
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Twelve-Week Home
Use of Hybrid Closed-Loop Insulin Delivery System vs.
Sensor-
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Assisted Pump
Therapy in Adults with Type 1 Diabetes—Intermediate Results of
the
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Multicenter
Randomized Crossover Diabeloop WP7 Trial
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78th Scientific Sessions
News
Briefing: Advances in Technology, Saturday,
June 23, 11:30 a.m. ET
Session Title: Clinical Trials in Type 1
Diabetes
Session Type: Oral Presentations
Location: W308
Session Time: Sunday, June 24,
2018, 2:15 - 4:15 pm
SYLVIA FRANC, PIERRE
Y. BENHAMOU, SOPHIE BOROT,
LUCY CHAILLOUS, BRIGITTE DELEMER, BRUNO
GUERCI, HÉLÈNE HANAIRE, NATHALIE M. JEANDIDIER, SR.,
ERIC RENARD, YVES REZNIK, PAULINE SCHAEPELYNCK, CHARLES
THIVOLET, GUILLAUME CHARPENTIER, Corbeil-Essonnes,
France, Grenoble, France, Besançon, France, Nantes, France, Reims, France, Vandœuvre-lès-Nancy, France, Toulouse,
France, Strasbourg, France,
Montpellier, France, Caen,
France, Marseille, France, Lyon, France
Objective: Availability of closed-loop insulin delivery
systems is expected by patients with type 1 diabetes. Our main
objective was to assess whether patients using the Diabeloop
artificial pancreas system could achieve a better glucose control
compared to sensor-assisted pump therapy, as measured by percentage
time in range 70-180 mg/dl.
Methods: A multicenter clinical trial was conducted in a
home setting, using an MPC-based algorithm, a hybrid monohormonal
system (CellNovo® pump and Dexcom G5® sensor) and centralized
remote monitoring. Adult patients with T1D for ≥ 2 years, pump
therapy for ≥ 6 months, HbA1c ≤ 10%, and preserved hypoglycemia
awareness were included among 12 investigation centers. Design was
a crossover trial with a 2-week run-in period, followed by 2
sequences of 12 weeks each separated with washout. Results of the
first 12-week arm are reported.
Results: 68 patients (27 men, age 47.2±13.4 years, HbA1c
7.6±0.9%, duration of disease 27.9±13.2 years) were randomized
between closed-loop (CL, n=33) and open-loop (OL, n=35) first.
During the first 12-week period, time spent in the 70-180 mg/dl
range was 69.5% [62.4;75.6] in CL vs. 58.7% [45.2;64.9] in OL. Time
in hypoglycemia <70 mg/dl was 2.1% [1.2;2.6] in CL vs. 4.1%
[1.9;6.1] in OL.
Conclusion: The Diabeloop closed-loop system was efficient
regarding metabolic outcomes.
Author Disclosure Block: S.
Franc: Consultant; Self; Animas Corporation, Johnson &
Johnson Diabetes Institute, LLC., Roche Diabetes Care Health and
Digital Solutions. P.Y. Benhamou: Advisory Panel;
Self; Diabeloop S.A. Consultant; Self; Abbott, Novo Nordisk Inc.,
Sanofi. Other Relationship; Self; Eli Lilly and Company, Roche
Diabetes Care Health and Digital Solutions. S.
Borot: Consultant; Self; Abbott, Animas Corporation,
Johnson & Johnson Diabetes Institute, LLC., Medtronic, Roche
Diabetes Care Health and Digital Solutions. L.
Chaillous: None. B. Delemer: Other
Relationship; Self; Eli Lilly and Company,
Sanofi-Aventis. B. Guerci: None. H.
Hanaire: Consultant; Self; Abbott, Animas Corporation,
Johnson & Johnson Diabetes Institute, LLC., Medtronic, Roche
Diabetes Care Health and Digital Solutions. N.M.
Jeandidier: Board Member; Self; Sanofi-Aventis. E.
Renard: Advisory Panel; Self; Abbott. Board Member; Self;
Eli Lilly and Company, Insulet Corporation, Novo Nordisk A/S, Roche
Pharma, Sanofi. Consultant; Self; Air Liquide. Research Support;
Self; Dexcom, Inc., Roche Pharma, TypeZero Technologies,
Inc. Y. Reznik: None. P.
Schaepelynck: Board Member; Self; Novo Nordisk A/S.
Consultant; Self; Roche Diabetes Care Health and Digital Solutions.
Speaker's Bureau; Self; Abbott, Eli Lilly and Company, Medtronic
MiniMed, Inc., Sanofi-Aventis. C.
Thivolet: Advisory Panel; Self; Abbott, Medtronic MiniMed,
Inc., Sanofi-Aventis. G. Charpentier: Consultant;
Self; Abbott, Dexcom, Inc., Medtronic.
Press Office in Orlando
June 22 - 26, 2018
407-685-4010
Contact:
Michelle Kirkwood
(703) 299-2053
mkirkwood@diabetes.org
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SOURCE American Diabetes Association