FLAIR—An NIDDK-Sponsored International, Multisite Randomized Crossover Trial of AHCL vs. 670G

Richard M. Bergenstal, MD

ADA 2020 - Oral session

2 minute listen
6 minute read

Key messages

  • In this first comparative trial of approved devices for automated insulin delivery, Advanced Hybrid Closed-Loop was superior to MINIMED 670G in reducing daytime hyperglycemia without increasing hypoglycemia.
  • Both systems were safe.
  • Advanced Hybrid Closed-Loop was superior to 670G for 24-hour glucose time in range of 70-180 mg/dL, reducing HbA1c and overall treatment satisfaction.
  • Background

    What do we already know about this topic?
  • Findings

    What does this study add?
  • Perspectives

    How does this study impact clinical practice?
  • Expert commentary

    by Amy Sanghavi Shah, MD, MS

Key messages

  • In this first comparative trial of approved devices for automated insulin delivery, Advanced Hybrid Closed-Loop was superior to MINIMED 670G in reducing daytime hyperglycemia without increasing hypoglycemia.
  • Both systems were safe.
  • Advanced Hybrid Closed-Loop was superior to 670G for 24-hour glucose time in range of 70-180 mg/dL, reducing HbA1c and overall treatment satisfaction.

Background

What do we already know about this topic?

  • Automated insulin delivery consists of a pump, connected continuous glucose monitoring, and automated dosing algorithm.
  • No prior study has a commercially approved automated insulin delivery arm.

How was this study conducted?

  • This trial (NCT03040414) compared the Advanced Hybrid Closed-Loop (AHCL) system to 670G.
  • Patients were randomized to one of the devices for 12 weeks and then crossed over to the other device for another 12 weeks.
  • 111 people (adolescents and young adults, age 14 to 29) with type 1 diabetes of seven international diabetes centers completed the trial; mean HbA1c was 7.9% at baseline.

Findings

What does this study add?

  • Compared to baseline (42%), glucose time >180 mg/dL during daytime decreased to 37% and 34% with 670G and AHCL, respectively.
  • Glucose profiles were consistently lower with AHCL vs. 670G.
  • TIR (time in range)70-180 was 63% with 670G and 67% with AHCL compared to 57% at baseline; time >180 mg/dL was 34% with 670G and 31% with AHCL vs. 41% at baseline.
  • Changes in TIR were seen across all age groups, baseline HbA1c, and previous use of technology.
  • Compared to a baseline of 7.9%, HbA1c decreased to 7.6% and 7.4% with 670G and AHCL, respectively.
  • Patient reported satisfaction significantly favored AHCL over 670G.
  • Safety analyses have shown 6 events for 670G (3 hyperglycemia or ketosis related to insulin pump problem; 1 hyperglycemia or ketosis not related to insulin pump problem; 2 other serious adverse events), and 3 for AHCL (1 severe hypoglycemia; 2 hyperglycemia or ketosis related to insulin pump problem).

Perspectives

How does this study impact clinical practice?

  • AHCL was superior to 670G in reducing daytime hyperglycemia by -3% points, without increasing hypoglycemia.
  • Both systems were safe regarding severe hypoglycemia and diabetic ketoacidosis.
  • AHCL was superior to 670G for 24 TIR70-180.
  • HbA1c was reduced by 0.5% with AHCL and by 0.3% with 670G.
  • AHCL was superior to 670G in overall treatment satisfaction.

Perspectives

How does this study impact clinical practice?

  • AHCL was superior to 670G in reducing daytime hyperglycemia by -3% points, without increasing hypoglycemia.
  • Both systems were safe regarding severe hypoglycemia and diabetic ketoacidosis.
  • AHCL was superior to 670G for 24 TIR70-180.
  • HbA1c was reduced by 0.5% with AHCL and by 0.3% with 670G.
  • AHCL was superior to 670G in overall treatment satisfaction.

This is a highlights summary of an oral session given at the ADA 2020 - 80th Scientific Sessions and presented by:

Richard M. Bergenstal, MD
International Diabetes Center, Minneapolis, Minnesota, MN, USA

The content is produced by Infomedica, the official reporting partner of ADA 2020 Virtual Meeting. The summary text was drafted by Patrick Moore, PhD, and reviewed by Marco Gallo, MD, an independent external expert, and approved by Dana M. Dabelea, MD, PhD, the scientific editor of the program.

The presenting authors of the original session had no part in the creation of this conference highlights summary.

In addition, an expert commentary on the topic has been provided by:

Amy Sanghavi Shah, MD, MS
Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Amy Sanghavi Shah, MD, MS
Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Dr. Shah is an Associate Professor in the Division of Endocrinology at Cincinnati Children's Hospital Medical Center.



Diabetes
Clinical Diabetes/Therapeutics


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