Tag: Insulin

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Extended-wear insulin infusion set lasts 7 days for most wearers, with few adverse events

Extended-use insulin infusion survival rate


Disclosures:
Medtronic provided research support to conduct the study. Buckingham reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.


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A novel extended-wear insulin infusion set was usable for up to 7 days for most adults with type 1 diabetes, with no change in glycemic control and few adverse events, according to findings published in Diabetes Technology & Therapeutics.

In findings from a single-arm nonrandomized trial, adults with type 1 diabetes used an extended-wear insulin infusion set from Medtronic along with their own MiniMed 670G system and insulin lispro or insulin aspart for up to 7 days. The overall survival rate at 7 days was 77.8%, with most participants preferring the extended-wear set to standard insulin infusion sets worn before the trial.


Extended-use insulin infusion survival rate

Extended use insulin infusion sets from Medtronic have a 6-day survival rate above 80% and a 7-day survival rate greater than 75%. Data were derived from 
Brazg R, et al. Diabetes Technol Ther. 2022;doi:10.1089/dia.2021.0540.

“Since 2017, Medtronic began designing a new insulin infusion set with a longer-wear duration and improved performance based on observations that insulin degradation and preservative loss increased the inflammatory response and insulin-associated inflammation contributed to standard insulin infusion set failure,” Bruce A. Buckingham, MD, active professor emeritus at the Stanford University School of Medicine Center for Academic Medicine, and colleagues wrote. “Iterative advancements relative to earlier insulin infusion set devices designed for 2 to 3 days of wear included a new H-cap connector and tubing with new fluid path design that improve insulin preservative retention and stability, in addition to a new extended-wear adhesive patch that improves skin adherence. The aim of this pivotal clinical trial was to validate a new extended-wear infusion set as safe and effective when used for up to 7 days in adults managing type 1 diabetes.”

At 15 investigational centers in the U.S., researchers enrolled 259 adults aged 18 to 80 years with type 1 diabetes for more than 1 year who used the MiniMed 670G insulin pump system (52% women; mean age, 45 years). Each participant received 12 extended-wear infusion sets to use with their own insulin pump for the duration of the study. Each set was to be worn for up to 7 days, and participants wore 12 consecutive infusion sets during the trial’s duration. The extended-wear infusion set was to be worn for at least 174 hours or until it failed. Any signs of infection were self-reported. Participants answered questions about standard infusion set use and satisfaction prior to the trial. Insulin pump data were uploaded during follow-up visits and used infusion sets were collected. Adverse events were reported at each follow-up visit. The final follow-up included an HbA1c measurement and an exit questionnaire.

Strong survival rate for extended-use infusion set

Of the 259 adults who enrolled, 248 completed the trial. A total of 3,041 sets were used. There were no serious adverse device effects, unanticipated adverse device effects or cases of diabetic ketoacidosis reported. The rate of severe hypoglycemia was 2.5 events per 100 participant-years, the rate of severe hyperglycemia was 104.1 events per 100 participant-years and the rate of skin infections was 20.1 events per 100 participant-years.

The survival rate of the extended infusion set was 83.8% at day 6, and 77.8% at day 7. The failure rate due to unexplained hyperglycemia and device-related severe hyperglycemia was less than 2% for both insulin lispro and insulin aspart.

Compared with baseline, HbA1c with use of the extended-use infusion set declined from 7.2% to 7.1%. Total insulin dosage remained stable across the 7-day wear period.

Most participants extremely satisfied

Participant satisfaction at the end of the study was higher with the extended-use infusion set compared with the standard insulin infusion set (P < .001). At least 66% of participants stated they were extremely satisfied with ease of insertion, comfort of wear, duration of wear, time required to change and convenience of use with the extended infusion set compared with fewer than 40% who were extremely satisfied with the standard insulin infusion set in each category.

“Opportunities for insulin infusion set technology advancement have not only included extending the duration of insulin infusion set wear, but also maintaining glycemic control, while mitigating adverse events across wear duration,” the researchers wrote. “The Medtronic extended infusion set was safely worn for up to 7 days by adults without adversely affecting glycemic control and with favorable user satisfaction.”


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Study provides new understanding of the earliest molecular events in Type 1 Diabetes pathogenesis

Study provides new understanding of the earliest molecular events in Type 1 Diabetes pathogenesis

For the first time, researchers have revealed that during the development of Type 1 Diabetes (T1D), when insulin-producing cells in the pancreas are under attack from T lymphocytes, the cells lining the pancreatic duct reprogram themselves in an attempt to suppress autoimmune T cell responses. This study is published today in Nature Metabolism.

The first events that occur in a patient heading towards Type 1 Diabetes, the events that trigger autoimmunity, have been difficult for researchers to pin down because of our inability to biopsy the pancreas, and the fact that clinical diagnosis is only made once massive beta cell destruction has occurred. That is why it is so important to develop a better understanding of the earliest molecular events in T1D pathogenesis, so we can uncover more about biomarker identification and disease prevention.”


Golnaz Vahedi, PhD, senior author, associate professor of Genetics and member of the Institute for Diabetes, Obesity and Metabolism, Perelman School of Medicine at the University of Pennsylvania

Autoimmune diseases, which affect as many as 23.5 million Americans, occur when the body’s immune system attacks and destroys healthy organs, tissues and cells. There are more than 80 types of autoimmune diseases, including rheumatoid arthritis, inflammatory bowel disease, and T1D. In T1D, immune cells called T lymphocytes attack and destroy insulin-secreting pancreatic beta cells and the pancreas stops producing insulin, the hormone that controls blood sugar levels.

“Although it might be an ultimately unsuccessful attempt of the pancreas to limit the adaptive T cell response responsible for destroying beta cells, this finding that the ductal cells are capable of playing this suppressive role towards autoimmune T cell responses is unprecedented,” said co-senior author Klaus Kaestner, PhD, the Thomas and Evelyn Suor Butterworth Professor in Genetics. “Our study shows that these cells, which had never previously been linked to immunity, may change themselves to protect the pancreas.”

Established in 2016, the Human Pancreas Analysis Program (HPAP) is supported by a $28 million grant from the National Institutes of Health with major contributions from Penn, the University of Florida and Vanderbilt University. The HPAP, which is co-directed by Kaestner and Ali Naji MD, PhD, the J. William White Professor of Surgical Research, started collecting pancreatic tissues from hundreds of deceased organ donors diagnosed with T1D. Because many T1D patients harbor beta cell autoantibodies called Glutamic Acid Decarboxylase (GAD) in their bloodstream years before clinical diagnosis, HPAP also collects samples from autoantibody-positive donors, who are at risk for developing T1D but have not received that diagnosis.

“Our study took those quality tissue samples and created high-resolution measurements of millions of cells from patients at various stages of T1D progression, resulting in a single-cell atlas of pancreatic islets,” said co-senior author R. Babak Faryabi, PhD, an assistant professor of Pathology and Laboratory Medicine and a core member of Epigenetics Institute at Penn.

Blood tests to check for levels of GAD are common for patients with, or at risk for, T1D, and doctors use it as a diagnostic tool. Another finding of this study is the new understanding of what is happening on a molecular level in the pancreas and how it correlates to the findings of the GAD test.

“Our study is the first to show that even when a person is not clinically considered to have T1D, high levels detected in their GAD test indicate large-scale transcriptional remodeling of their beta cells,” said Naji, a study co-senior author. “It solidifies to clinicians to closely monitor patients with increasing levels of GAD, as we now know what cellular and molecular changes are in motion in relation to those levels.”

Although researchers do not yet know whether these transcriptional changes are contributing to or are consequences of disease pathogenesis, the discovery of molecular phenotypic changes in pancreatic cells of autoantibody-positive individuals advances the understanding of early pancreatic changes occurring in T1D, and sets the course for continued research in this area.

Source:

University of Pennsylvania School of Medicine

Journal reference:

Fasolino, M., et al. (2022) Single-cell multi-omics analysis of human pancreatic islets reveals novel cellular states in type 1 diabetes. Nature Metabolism. doi.org/10.1038/s42255-022-00531-x.