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

N/AActive Not RecruitingNCT04414280

Universitaire Ziekenhuizen KU Leuven1,150 enrolled

Overview

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 new kinds of insulin pumps on glycemic control and patient-reported outcomes (PROMs) is still unclear. Therefore, this study will evaluate the impact of the Medtronic MiniMed 670G, Medtronic MiniMed 780G and Tandem Control-IQ systems on glycemic control and PROMs in people living with type 1 diabetes under real-life conditions. In a multicenter real-world observational study, 350 adults and 100 children with type 1 diabetes who are treated with each of these systems in one of 17 Belgian centers, will be followed for a period of 24 months. 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.

Study Type

OBSERVATIONAL

Enrollment

1,150

Conditions

Diabetes Mellitus, Type 1

Interventions

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.

Medtronic MiniMed 780GDEVICE

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.

Tandem Control-IQDEVICE

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.

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with type 1 diabetes * patients aged 6 years or older * patients starting with hybrid closed-loop therapy (as part of routine clinical practice) in one of the 17 participating centers. Note: the decision about which patient to start, is left to the clinical judgement of the treating health care professional. * patients who signed informed consent Exclusion Criteria: * patients without type 1 diabetes * patients under 6 years of age * patients not starting with hybrid closed-loop therapy in one of the 17 participating centers * patients who did not sign informed consent

Locations (18)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

OLVZ Aalst

Aalst, Belgium

GZA Ziekenhuizen - campus Sint-Vincentius

Antwerp, Belgium

Hôpital d'Arlon

Arlon, Belgium

Imeldaziekenhuis

Bonheiden, Belgium

AZ Sint-Jan - campus Sint-Jan

Bruges, Belgium

Hôpital Erasme

Brussels, Belgium

UZ Antwerpen

Edegem, Belgium

ZOL - campus Sint-Jan

Genk, Belgium

Jessa Ziekenhuis - campus Salvator

Hasselt, Belgium

...and 8 more locations

Outcomes

Primary Outcomes

Time in range

The evolution of percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start

Time frame: 12 months

Secondary Outcomes

Time in range

Percentage of time spent in range (sensor glucose 70-180 mg/dL), with exclusion of the primary endpoint