The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs

Summary

Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies, the impact of these automated insulin delivery systems on glycemic management and patient-reported outcomes (PROMs) under real-world conditions is still unclear. Therefore, this prospective, multicenter real-world observational study will evaluate the real-world impact of the Medtronic MiniMed 670G, Medtronic MiniMed 780G, Tandem Control-IQ and Omnipod 5 systems, separately, on glycemic management and PROMs in people living with type 1 diabetes and to evaluate the safety of the Medtronic MiniMed 780G in young children with type 1 diabetes (2-6 years old). Participants will be followed in routine clinical practice for a period of 24 months after initiation of the system. The primary endpoint is the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dL) from before start to 12 months after start of hybrid closed-loop therapy.

Since not much is known about the impact of hybrid closed-loop on partners of adults living with type 1 diabetes, an optional substudy (INRANGE-PARTNER) will be performed investigating the quality of life in partners of adults of type 1 diabetes using hybrid closed-loop therapy. More specifically, the substudy will compare the quality of life of partners of type 1 diabetes patients both before and after implementation of hybrid closed-loop therapy.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DEVICE

Medtronic MiniMed 670G

The Medtronic Minimed 670G system is a form of hybrid closed-loop insulin delivery. The Medtronic MiniMed 670G system automatically adjusts basal insulin every five minutes based on CGM readings to reach a glucose target of 120 mg/dL, the SmartGuard Auto Mode. Patients still need to enter their carbohydrate intake and administer meal-time and correction boluses. Before Auto Mode is introduced, the Medtronic MiniMed 670G system has to be worn in Manual Mode. In contrast to Auto Mode, Manual Mode features an insulin stop up to 30 minutes before or when reaching preset low limits (suspend before/on low) and an automatic insulin restart when blood sugar levels recover. During Manual Mode the pump 'becomes familiar with' the daily insulin need of the patient. This information will be used when in Auto Mode.

DEVICE

Medtronic MiniMed 780G

The Medtronic Minimed 780G system differs in several aspects from the MiniMed 670G system. In Auto Mode, the user can choose from two target levels for even more stricter glucose control (100 mg/dL and 120 mg/dL) and correction boluses are now automated without the need of user interaction. When administering meal boluses, no capillary blood glucose value is required. The safety feature to exit from Auto Mode to Manual Mode was too strict in the Minimed 670G. In the Minimed 780G this is more flexible to overcome this frequently reported patient frustration.

DEVICE

Tandem Control-IQ

The Tandem t:slim X2 Control-IQ consists of the Tandem t:slim X2 insulin pump with Control-IQ technology, and integrates with the Dexcom G6 CGM-device via Bluetooth. Blood glucose readings for calibration are not required. The Tandem t:slim X2 Control-IQ automatically adjusts basal insulin based on CGM readings to reach a glucose target range between of 112-160 mg/dL. Patients still need to enter their carbohydrate intake and administer meal-time boluses, but the system automatically increases the basal insulin dose or gives automated correction boluses in case of high blood glucose levels. The technology offers optional settings for sleep and exercise, with different glucose targets in order to match the insulin need during these activities. New versions of the pump software can be downloaded and installed remotely via the user's own computer.

DEVICE

Omnipod 5

The Omnipod® 5 (Insulet Corporation, Acton, MA, USA) consists of the tubeless Omnipod 5 insulin pump system with SmartAdjust™ technology and integrates with the Dexcom G6 and Freestyle Libre 2 plus CGM-device via Bluetooth. The Omnipod 5 system automatically adjusts insulin delivery every 5 minutes based on CGM readings to reach a customizable glucose target between 110-150 mg/dL. People still need to enter their carbohydrate intake and administer meal-time boluses, but the system automatically adjusts insulin delivery in response to predicted glucose levels. The technology offers an Activity feature with a higher glucose target to reduce the risk of hypoglycemia during exercise or other periods of increased insulin sensitivity. As a tubeless patch pump system, insulin delivery is managed directly through the wearable Pod, which is controlled via the dedicated controller or compatible smartphone application.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Pieter Gillard, MD · UZ Leuven

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-12

Primary Completion

2028-04-30

Completion

2028-04-30

FDA Device

Yes

Countries

• Belgium

Study Locations