Most people with diabetes receive their diabetes care in a primary care/family medicine clinical setting (50% of adults with type 1 and 90% of all people with type 2).

A large percentage of those patients use traditional insulin pumps to manage their condition. And, while the technology offers effective treatment for diabetes – it does require significant work on behalf of the healthcare team and the patient. The healthcare team must take time to calculate and input many insulin rates and ratios, and patients must learn to calculate carbohydrates and input the grams of carbohydrates into the system prior to eating, as well as learn how to adjust rates for exercise, illness, stress, and more.

Enter automated insulin delivery (AID) systems. Specifically, the iLet AID system.

“With the iLet, all that is needed is input of the patient’s weight. The iLet then uses three different algorithms to give or withhold insulin based on the blood sugar and the speed at which the blood sugar is rising or falling,” says University of Colorado Department of Family Medicine associate professor and founder and director of the Primary Care Diabetes Lab, Dr. Tamara Oser.

Dr. Oser says iLet provides the opportunity for more people with diabetes to successfully manage their conditions in consultation with their primary care provider and avoid the need to see a specialist like an endocrinologist.

“The iLet learns what the patient needs and delivers,” says Oser. “Especially in primary care practices, where only 36% have a diabetes care and education specialist even part-time, this is crucially important. Most primary care practices do not have the workflow or resources to start traditional insulin pumps.”

With that said, Oser and her colleague and husband, Dr. Sean Oser, are undertaking a study of iLet in primary care settings.

It is called, PREPARE 4 AID: Primary Care Pragmatic Real World Experience for Automated Insulin Delivery.

“This is a three-year, $4.5 million study that will consist of a randomized controlled trial of 140 people with insulin-treated diabetes (type 1 or type 2 diabetes) randomized to the iLet AID system or their standard care for 3 months, followed by an observational extension of 3 months more in which all participants will use the iLet AID system,” says Oser.

The trial itself is intended to replicate as closely as possible what the primary care experience and effort would be in ordering this system and starting it with patients for clinical use.

The plan is to recruit and onboard 100-110 participants through the CU site at the Primary Care Diabetes Lab, while partners at Massachusetts General Hospital plan to recruit an additional 30-40 participants – with the first patients enrolled in late Winter 2023 or early Spring 2024.

    
                Dr. Tamara Oser                                             Dr. Sean Oser                 

Learn more about the University of Colorado Primary Care Diabetes Lab.