The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs
INRANGE
1 other identifier
observational
1,600
1 country
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2020
Longer than P75 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2020
CompletedFirst Submitted
Initial submission to the registry
April 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
May 27, 2026
May 1, 2026
8.1 years
April 10, 2020
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (28)
Time in range
from before start to 4, 8, 12 and 24 months after start
Time in tight range
from before start to 4, 8, 12 and 24 months after start
Time in level 2 hypoglycemia
from before start to 4, 8, 12 and 24 months after start
Time in level 1 hypoglycemia
from before start to 4, 8, 12 and 24 months after start
Time below range
from before start to 4, 8, 12 and 24 months after start
- +23 more secondary outcomes
Other Outcomes (25)
Severe hypoglycemia
from before start to 4, 8, 12 and 24 months after start
Diabetic ketoacidosis
from before start to 4, 8, 12 and 24 months after start
Hospital visits and/or admissions
from before start to 4, 8, 12 and 24 months after start
- +22 more other outcomes
Study Arms (5)
People with type 1 diabetes using Medtronic MiniMed 670G
People with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 670G system (as part of routine clinical practice) in one of the 26 participating centers and who signed informed consent are eligible to participate. The decision about which person to start, is left to the clinical judgement of the treating health care professional.
People with type 1 diabetes using Medtronic MiniMed 780G
People with type 1 diabetes, aged 7 years or older, who start with the Medtronic MiniMed 780G system (as part of routine clinical practice) in one of the 26 participating centers and who signed informed consent are eligible to participate. The decision about which person to start, is left to the clinical judgement of the treating health care professional.
People with type 1 diabetes using Tandem Control-IQ
People with type 1 diabetes, aged 6 years or older, who start with the Tandem Control-IQ system (as part of routine clinical practice) in one of the 26 participating centers and who signed informed consent are eligible to participate. The decision about which person to start, is left to the clinical judgement of the treating health care professional.
Young children (2-6 years) with type 1 diabetes using Medtronic MiniMed 780G
Young children with type 1 diabetes, aged 2-6 years, who start with the Medtronic 780G system (as part of routine clinical practice) in one of the 26 participating centers and whose parents signed informed consent are eligible to participate. The decision about which child to start, is left to the clinical judgement of the treating health care professional.
People with type 1 diabetes using Omnipod 5
People with type 1 diabetes, aged 2 years or older, who start with the Omnipod 5 system (as part of routine clinical practice) in one of the 26 participating centers and who signed informed consent are eligible to participate. The decision about which person to start, is left to the clinical judgement of the treating health care professional.
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.
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.
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.
Eligibility Criteria
Participants will be recruited at 26 diabetes convention hospitals in Belgium
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (38)
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
AZORG
Aalst, 9300, Belgium
GZA Ziekenhuizen - campus Sint-Vincentius
Antwerp, 2018, Belgium
ZAS - pediatrics
Antwerp, 2020, Belgium
Hôpital d'Arlon
Arlon, 6700, Belgium
Imeldaziekenhuis
Bonheiden, 2820, Belgium
AZ Sint-Jan - pediatrics
Bruges, 8000, Belgium
AZ Sint-Jan
Bruges, 8000, Belgium
Hôpital Universitaire des Enfants Reine Fabiola - pediatrics
Brussels, 1020, Belgium
Hôpital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires St. Luc - pediatrics
Brussels, 1200, Belgium
Cliniques Universitaires St. Luc
Brussels, 1200, Belgium
Grand Hôpital de Charleroi - pediatrics
Charleroi, 6000, Belgium
UZ Antwerpen - pediatrics
Edegem, 2650, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
ZOL Sint-Jan
Genk, 3600, Belgium
UZ Gent - pediatrics
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
Jessa - pediatrics
Hasselt, 3500, Belgium
Jessa
Hasselt, 3500, Belgium
UZ Brussel - pediatrics
Jette, 1090, Belgium
UZ Brussel
Jette, 1090, Belgium
AZ Groeninge - campus kennedylaan
Kortrijk, 8500, Belgium
CHR Citadelle
Liège, 4000, Belgium
CHU de Liège - site du Sart Tilman
Liège, 4000, Belgium
Clinique CHC Montlégia - pediatrics
Liège, 4000, Belgium
Clinique CHC Montlégia
Liège, 4000, Belgium
CHR Citadelle - pediatrics
Liège, 4030, Belgium
ZOL Maas en Kempen - pediatrics
Maaseik, 3680, Belgium
CHU Helora
Mons, 7000, Belgium
AZ Oostende
Ostend, 8400, Belgium
AZ Delta - pediatrics
Roeselare, 8800, Belgium
AZ Delta
Roeselare, 8800, Belgium
Vitaz - pediatrics
Sint-Niklaas, 9100, Belgium
VITAZ
Sint-Niklaas, 9100, Belgium
AZ Turnhout - pediatrics
Turnhout, 2300, Belgium
GZA Ziekenhuizen - campus Sint-Augustinus
Wilrijk, 2610, Belgium
CHU UCL Namur - pediatrics
Yvoir, 5530, Belgium
Related Publications (3)
De Meulemeester J, Valgaerts L, Tenoutasse S, Gies I, den Brinker M, Fudvoye J, Mouraux T, Louis J, Lambert S, Van Loocke M, Smeets G, Lemay A, Ryckx S, Depoorter S, Van Aken S, Maris E, Mathieu C, Gillard P, Casteels K. One-year effectiveness and safety in young children aged 2-6 years with type 1 diabetes using an automated insulin delivery system: A real-world prospective cohort study. Diabetes Obes Metab. 2026 Jan;28(1):551-561. doi: 10.1111/dom.70228. Epub 2025 Oct 27.
PMID: 41144887RESULTDe Meulemeester J, Valgaerts L, Massa G, Gies I, Depoorter S, Van Aken S, Chivu O, den Brinker M, Mouraux T, Van Loocke M, Lebrethon MC, Messaaoui A, Lysy P, Dooms L, Mathieu C, Casteels K, Gillard P. Real-World Glycemic and Person-Reported Outcomes After Tandem Control-IQ Initiation in Children With Type 1 Diabetes. J Clin Endocrinol Metab. 2025 Nov 18;110(12):3331-3341. doi: 10.1210/clinem/dgaf265.
PMID: 40333328RESULTDe Meulemeester J, Keymeulen B, De Block C, Van Huffel L, Taes Y, Ballaux D, Spincemaille K, Lapauw B, Vanhaverbeke G, Lowyck I, Vercammen C, Colin IM, Preumont V, Charleer S, Fieuws S, Mathieu C, Gillard P. One-year real-world benefits of Tandem Control-IQ technology on glucose management and person-reported outcomes in adults with type 1 diabetes: a prospective observational cohort study. Diabetologia. 2025 May;68(5):948-960. doi: 10.1007/s00125-025-06366-x. Epub 2025 Feb 11.
PMID: 39934368RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pieter Gillard, MD
UZ Leuven
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
April 10, 2020
First Posted
June 4, 2020
Study Start
March 12, 2020
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
May 27, 2026
Record last verified: 2026-05