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.
Study Type
OBSERVATIONAL
Enrollment
1,600
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.
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.
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.
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.
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
AZORG
Aalst, Belgium
GZA Ziekenhuizen - campus Sint-Vincentius
Antwerp, Belgium
ZAS - pediatrics
Antwerp, Belgium
Hôpital d'Arlon
Arlon, Belgium
Imeldaziekenhuis
Bonheiden, Belgium
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
Time in range
Percentage of time spent in range (sensor glucose 70-180 mg/dL), with exclusion of the primary endpoint
Time frame: from before start to 4, 8, 12 and 24 months after start
Time in tight range
Percentage of time spent in tight range (sensor glucose 70-140 mg/dL)
Time frame: from before start to 4, 8, 12 and 24 months after start
Time in level 2 hypoglycemia
Percentage of time spent in level 2 hypoglycemia (sensor glucose \<54 mg/dL)
Time frame: from before start to 4, 8, 12 and 24 months after start
Time in level 1 hypoglycemia
Percentage of time spent in level 1 hypoglycemia (sensor glucose \<70 mg/dL and ≥54 mg/dL)
Time frame: from before start to 4, 8, 12 and 24 months after start
Time below range
Percentage of time spent below range (sensor glucose \<70 mg/dL)
Time frame: from before start to 4, 8, 12 and 24 months after start
Time above range
Percentage of time spent above range (sensor glucose \>180 mg/dL)
Time frame: from before start to 4, 8, 12 and 24 months after start
Time in level 1 hyperglycemia
Percentage of time spent in level 1 hyperglycemia (sensor glucose ≥180 mg/dL and \<250 mg/dL)
Time frame: from before start to 4, 8, 12 and 24 months after start
Time in level 2 hyperglycemia
Percentage of time spent in level 2 hyperglycemia (sensor glucose \>250 mg/dL)
Time frame: from before start to 4, 8, 12 and 24 months after start
Time above 140 mg/dL
Percentage of time spent \>140 mg/dL
Time frame: from before start to 4, 8, 12 and 24 months after start
HbA1c
HbA1c
Time frame: from before start to 4, 8, 12 and 24 months after start
Mean glucose concentration
Mean glucose concentration
Time frame: from before start to 4, 8, 12 and 24 months after start
Glycemic variability
Glycemic variability: coefficient of variation (CV), standard deviation (SD) and mean amplitude of glycemic excursions (MAGE)
Time frame: from before start to 4, 8, 12 and 24 months after start
Glucose management indicator
Glucose management indicator
Time frame: from before start to 4, 8, 12 and 24 months after start
Glycemic risk index
Glycemic risk index
Time frame: from before start to 4, 8, 12 and 24 months after start
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))
Time frame: from before start to 4, 8, 12 and 24 months after start for adults
Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))
Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (\<4 times "R"))
Time frame: from before start to 4, 8, 12 and 24 months after start for adults and children
Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))
Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))
Time frame: from before start to 4, 8, 12 and 24 months after start for adults and children
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
Time frame: from before start to 4, 8, 12 and 24 months after start for adults
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
Time frame: from before start to 4, 8, 12 and 24 months after start for adults
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
Time frame: from before start to 4, 8, 12 and 24 months after start for adults
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))
Time frame: from before start to 4, 8, 12 and 24 months after start for adults
Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))
Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))
Time frame: from before start to 4, 8, 12 and 24 months after start for adults
Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G/780G system (multiple choice)
Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G/780G system (multiple choice)
Time frame: at 4, 8, 12 and 24 months after start of the Medtronic MiniMed 670G and 780G system for adults and children
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))
Time frame: from before start to 4, 8, 12 and 24 months after start for children
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
Time frame: from before start to 4, 8, 12 and 24 months after start for children
The Diabetes Quality of Life for Youth (DQOLY) questionnaire
The Diabetes Quality of Life for Youth (DQOLY) questionnaire
Time frame: from before start to 4, 8, 12 and 24 months after start for children
Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)
Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)
Time frame: from before start to 4, 8, 12 and 24 months after start for parents
The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents
The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents
Time frame: from before start to 4, 8, 12 and 24 months after start for parents
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AZ Sint-Jan - pediatrics
Bruges, Belgium
AZ Sint-Jan
Bruges, Belgium
Hôpital Universitaire des Enfants Reine Fabiola - pediatrics
Brussels, Belgium
Hôpital Erasme
Brussels, Belgium
...and 28 more locations