Pivotal Trial for Tandem’s Predictive Low Glucose Suspend (PLGS) System

By Ben Pallant and Adam Brown

A six-week study of Tandem’s first automated insulin delivery device with Dexcom’s G5 CGM

Clinical Trials Identifier: NCT03195140

Trial Name: Diabetes Pump With Predictive Low Glucose Suspend Pivotal Trial

Diabetes Type: Type 1 diabetes

What it’s testing: This trial is testing Tandem’s upcoming Predictive Low Glucose Suspend (PLGS) System. PLGS technology uses continuous glucose monitor (CGM) readings to predict hypoglycemia (low blood glucose) and take insulin dosing action. When a low is predicted, the pump will suspend basal insulin delivery to prevent or shorten the duration of a hypoglycemia event; once glucose levels start to rise, insulin delivery resumes. Everyone in this study will use Tandem’s t:slim x2 insulin pump (with a built-in PLGS algorithm) and Dexcom’s G5 CGM for six weeks. For three weeks, participants will use the pump and CGM without PLGS turned on, and for the other three weeks, they will use the same system with PLGS enabled. The main goal is to determine whether participants have fewer and/or shorter hypoglycemic events when using Tandem’s PLGS technology.

What it’s measuring: The study is primarily measuring time spent with glucose below 70 mg/dl (hypoglycemia) during the two three-week periods. As secondary measures, the study will also record time spent below 60 mg/dl and 50 mg/dl, number of hypoglycemic events, and time spent above 180 mg/dl and 250 mg/dl.

Why is this new/important: In previous studies, PLGS algorithms have done an excellent job in reducing the occurrence and duration of hypoglycemia. Outcomes are especially impressive overnight when people with diabetes are sleeping and cannot proactively respond to CGM levels. This trial will support an FDA submission of Tandem’s commercial PLGS system – a real product and not a research platform. Tandem hopes to launch its PLGS system in summer 2018.

Trial Length: 6 weeks

Trial Locations: The trial is currently recruiting at locations in New Haven, Connecticut; Aurora, Colorado; and centers in three California cities (Palo Alto, San Diego, and Santa Barbara).

Do you qualify? Select inclusion criteria:

• Age 6 or older (those under 18 years old must be living with one or more parents/guardians committed to participating in training and able to contact the participant in case of an emergency)

• Type 1 diabetes treated with insulin (pump or injections) for at least one year

• No major change in insulin therapy intensity in the last 3 months

Select Exclusion criteria include:

• Need to use acetaminophen (Tylenol or similar) during the study

• Participation in another trial at the time of enrollment or plans to participate in another study during the time period of this study

• Uncontrolled thyroid disease, kidney failure, hemophilia or another major bleeding disorder, or unstable cardiovascular disease.

For a full list of the trial’s inclusion criteria, please visit its webpage here.

Where to get more information: For more information about the trial, please contact Trevor J. Denbo, MS (858-224-6136; tdenbo@tandemdiabetes.com), or Vance Swanson (858-224-6103; vswanson@tandemdiabetes.com)