Fuzzy Logic Automated Insulin Regulation

Summary

Adolescents and young adults with type 1 diabetes often have a difficult time achieving good glucose control, which is so important in reducing the risk for diabetes complications. Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is still a need for many individuals to further improve glucose levels without causing low blood glucose levels (hypoglycemia) or adding to the daily burden of living with diabetes. Today an insulin pump can receive glucose readings from a continuous glucose monitor and adjust the insulin delivery in an attempt to keep glucose levels in a more optimal range. These systems are called hybrid closed loop (HCL). This means that much of the insulin delivery is automated, yet the patient still interacts regularly with the system, particularly to help determine the insulin dose to deliver to cover a meal. Results of early studies using HCL systems in adolescents and adults with type 1 diabetes are encouraging.

The objective of this study is to compare the efficacy and safety of the automated insulin delivery (AID) system with proportional integral-derivative (PID) algorithm (Minimed 670G 3.0 HCL) to an AID system with combined PID and Fuzzy Logic Algorithm (Minimed 670G 4.0 Advanced Hybrid Closed-Loop (AHCL)). The trial will test the hypothesis that the Minimed AHCL can reduce daytime hyperglycemia, currently the biggest challenge for AID systems, without increasing hypoglycemia.

Up to 124 adolescents and young adults (ages 14-\<30) will be recruited to test each system for three months in a randomized crossover trial. Investigators will compare how effective each hybrid closed loop system is at preventing high blood glucose readings during the day. The investigators will also evaluate the safety of each system and how participants adjust to the daily use of the technology.

Conditions

• Type 1 Diabetes Mellitus

Interventions

DEVICE

MedtronicMinimed 670G 3.0 hybrid closed loop system

The components of the intervention are the insulin pump with insulin delivery algorithm (PID).

DEVICE

Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.

The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Medtronic

  collaborator INDUSTRY

• Jaeb Center for Health Research

  collaborator OTHER

• Schneider Children's Medical Center, Israel

  collaborator OTHER

• University of Ljubljana

  collaborator OTHER

• Yale University

  collaborator OTHER

• Joslin Diabetes Center

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Stanford University

  collaborator OTHER

• International Diabetes Center at Park Nicollet

  collaborator OTHER

• Kinderkrankenhaus auf der Bult

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• HealthPartners Institute

  lead OTHER

Principal Investigators

• Richard Bergenstal, MD · International Diabetes Center, HealthPartners Institute

• Moshe Phillip, MD · Schneider Children's Medical Center, Israel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

14 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-03

Primary Completion

2020-04-20

Completion

2020-04-20

FDA Device

Yes

Countries

• United States
• Germany
• Israel
• Slovenia

Study Locations