Advanced Hybrid Closed-Loop Pivotal Safety Study

Bruce Bode, MD

ADA 2020 - Oral session

2 minute listen
5 minute read

Key messages

  • The automated Advanced Hybrid Closed-Loop system was effective in reducing mean HbA1c even in a well-controlled population of patients with type 1 diabetes.
  • No safety or device related issues were found in this 90-day trial.
  • 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

  • The automated Advanced Hybrid Closed-Loop system was effective in reducing mean HbA1c even in a well-controlled population of patients with type 1 diabetes.
  • No safety or device related issues were found in this 90-day trial.

Background

What do we already know about this topic?

  • The MINIMED Advanced Hybrid Closed-Loop (AHCL) system is an automated system for insulin delivery in persons with type 1 diabetes (T1D).
  • It is designed to maximize the glucose time in range (TIR) of 70-180 mg/dL.
  • The system auto basal adjusts every 5 minutes to target 100 or 120 mg/dL.

How was this study conducted?

  • The AHCL study investigated the use of the system.
  • The trial enrolled 157 individuals with T1D who were on pump therapy with or without continuous glucose monitoring.
  • Descriptive glycemic endpoints were used.
  • After the run-in patients were allocated to a glucose set point of 100 or 120 mg/dL for 45 days, and then crossed over to either 100 or 120 mg/dL.

Findings

What does this study add?

  • AHCL therapy improved mean HbA1c from 7.5% to 7.0%.
  • Almost twice as many patients achieved an HbA1c≤7.0% with AHCL therapy vs. baseline.
  • More participants achieved a TIR70-180 ≥70%.
  • This further increased for all groups at the basal target set point of 100 mg/dL.
  • There were no events of diabetic ketoacidosis, severe hypoglycemia during the study phase, serious or unanticipated adverse device effects.

Perspectives

How does this study impact clinical practice?

  • AHCL therapy achieved high %TIR with low %TBR (time below range) in this study in patients with T1D.
  • With a set point of 100 mg/dL and an AIT (active insulin time) setting of 2-3 hours, nearly 80% of participants achieved a TIR70-180 >70% without an increase in hypoglycemia.
  • AHCL therapy further improved glycemia control.

Perspectives

How does this study impact clinical practice?

  • AHCL therapy achieved high %TIR with low %TBR (time below range) in this study in patients with T1D.
  • With a set point of 100 mg/dL and an AIT (active insulin time) setting of 2-3 hours, nearly 80% of participants achieved a TIR70-180 >70% without an increase in hypoglycemia.
  • AHCL therapy further improved glycemia control.

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

Bruce Bode, MD
Atlanta Diabetes Associates, Atlanta, GA, 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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