Pivotal Trial for New Closed Loop System Seeks Type 1 Participants

By Kara Miecznikowski and Jamie Kurtzig

This study, now recruiting 350 participants, will examine the safety of the MiniMed 780G Advanced Hybrid Closed Loop System in people with type 1 diabetes (7+ Years)

Clinical Trials Identifier: NCT03959423

Trial name: Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects

Diabetes type: Type 1

What the trial is testing:

This three-month pivotal trial will test the safety of the next-gen MiniMed 780G in people with type 1 diabetes. The MiniMed 780G will improve on several features of the current 670G hybrid closed loop system: adding automatic correction boluses for high blood sugars, a time-in-range goal greater than 80%, an adjustable target glucose level of 100 mg/dl (versus the current “less aggressive” goal of 120 mg/dl), Bluetooth connectivity (for remote monitoring, wireless data upload), pump software updating from home (in-warranty upgrades), and simplifying the ability to stay in Auto Mode (goal of 99% time spent in closed loop). Auto Mode is when the closed loop system senses your glucose level and automatically adjusts basal insulin doses to bring you to toward the target glucose level. The CGM sensor will still require two fingerstick calibrations per day.

What the trial is measuring:

The trial will measure change in A1C and change in percent time in range (70-180 mg/dL) over a three-month period. The study will also measure the number of instances of hypoglycemia (less than 70 mg/dl) and diabetic ketoacidosis (DKA). Want to know more about time-in-range? See here!

Why is this new/important?

As a pivotal trial, the results from this study will be submitted to the FDA to support approval of the 780G, which aims to launch by June 2020. The new 780G will be an additional option to Tandem’s upcoming Control-IQ system (launch expected by the end of 2019, pending approval). We imagine Medtronic will have an upgrade program that allows in-warranty 670G users to get on the 780G – this information is not yet available.

In a small study presented as a poster at the 2019 ADA Scientific Sessions, the MiniMed 780G was rated by 100% of the 12 participants as the best device they had ever used. The 780G was shown to be safe, improve blood sugar, and simplify diabetes management, even when users forgot to administer a bolus of insulin at mealtime or the carb counting was inaccurate.

Trial length: 3 months

Trial locations: Recruiting locations include cities in California, Colorado, Georgia, Idaho, Minnesota, Washington. Click here for more details.

Would you like to take part? Selection eligibility criteria include:

• 7 to 75 years of age
• Diagnosis of type 1 diabetes
•  A1C below 10%
• Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
• Must have had pump therapy for greater than six months prior to screening (with or without CGM experience)
• See all eligibility criteria here.

Where to get more information:

Contact: Thomas Troub at thomas.troub@medtronic.com or Melissa Vella at melissa.vella@medtronic.com.