lazarus_11With an additional four clinical trials now available for patients with diabetes or prediabetes – including novel studies focused on pregnant women and African Americans – The Ohio State University continues to break new ground in battling a disease that now affects one in 10 Americans.

Improving outcomes among pregnant women with type 1 diabetes

In collaboration with University of Colorado, clinicians in Ohio State’s Division of Endocrinology, Diabetes and Metabolism have begun enrolling patients in a first-of-its-kind study investigating the safety and efficacy of an automated insulin delivery system. The Pregnancy Intervention with a Closed-Loop System (PICLS) trial will evaluate pregnant women with type 1 diabetes who receive hybrid closed-loop therapy via a pump that automatically adjusts insulin in response to feedback from a continuous glucose monitor.

“In our efforts to manage diabetes throughout pregnancy, lowering glucose to the recommended targets can lead to significant hypoglycemia,” says endocrinologist Elizabeth Buschur, MD, Ohio State’s principal investigator. “We’ll compare maternal and fetal outcomes among patients who received hybrid closed-loop therapy versus sensor-augmented pump therapy, as well as differences in safety, indices of glycemic variability, device satisfaction and quality of life.”

This study, which is funded by the Juvenile Diabetes Research Foundation, is open to pregnant women prior to nine weeks gestation who have type 1 diabetes.

Evaluating mindfulness-based cognitive therapy for diabetic patients with depression

Another study underway at Ohio State is examining the effects of mindfulness-based cognitive therapy (MBCT) on both depression symptoms and diabetes control.

“One out of two patients seen in our diabetes center has comorbid mood disorder along with diabetes,” says Joshua J. Joseph, MD, who is co-leading the project alongside psychologist Sophie Lazarus, PhD. “MBCT is an evidence-based group treatment that utilizes Eastern meditative practices and cognitive-behavioral principles. It’s been shown to reduce the risk of depressive relapses but has not been studied extensively in diabetes.”

Patients who enroll in the study will undergo an eight-week MBCT program that addresses their depression and diabetes.

Exploring a signaling pathway’s impact on hypertension and diabetes

In addition to co-directing the MBCT study, Dr. Joseph is principal investigator of a clinical trial that aims to understand the role of the renin-angiotensin-aldosterone system (RAAS) in African Americans with prediabetes.

“Fifty percent of African Americans will develop diabetes during their lifetime, and another 50% are currently living with hypertension,” Dr. Joseph says. “Population health studies have shown that the RAAS, a signaling pathway responsible for regulating the body's blood pressure, may be a driver of both diabetes and cardiovascular disease in African Americans.”

The randomized controlled trial – which is funded by the National Institute of Diabetes and Digestive and Kidney Diseases, and The Robert Wood Johnson Foundation – will examine blood pressure, central aortic pressure, pancreatic beta cell function and insulin resistance over six months in African Americans with prediabetes. Dr. Joseph and his team will compare outcomes among patients prescribed a medication targeting the RAAS and those prescribed a placebo.

Investigating beta cell replacement

Ohio State researchers are also participating in an early human study evaluating the safety and efficacy of an implantable pod that’s designed to provide all elements of an endocrine pancreas. Patients with type 1 diabetes and hypoglycemia unawareness, a major risk factor for life-threatening hypoglycemia, may be eligible for enrollment.

Helping assess a new implantable glucose monitor

In August 2019, Ohio State was selected to participate in a post-approval clinical study to evaluate the world’s first implantable continuous glucose monitor. 

“Continuous glucose monitoring has proven benefits for people with diabetes, but it’s underutilized for a variety of reasons including cost and convenience,” says Kathleen Dungan, MD, director of the endocrine clinical trials unit in Ohio State’s Division of Endocrinology, Diabetes and Metabolism. 

“Historically, sensors were inserted with a subcutaneous filament connected to an external transmitter and needed to be exchanged every one or two weeks,” adds Dr. Dungan. “Some patients found them impractical, while others experienced skin irritation or their sensor fell out prematurely.”

The new, fully implantable device, which was approved by the Food and Drug Administration in 2018, can be placed right in the office and exchanged every 90 days. The small sensor continuously measures glucose levels and sends information to a mobile app to alert users if their glucose levels are too high or too low.

Ohio State clinicians will soon begin assessing the long-term safety and effectiveness of this device over repeat insertion and removal cycles.

For more information about diabetes clinical trials at Ohio State, contact amber.anaya@osumc.edu.

Read more featured stories