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

May 21, 2026 updated by: prof dr Pieter Gillard, Universitaire Ziekenhuizen KU Leuven

The Impact of Hybrid Closed-loop Insulin Delivery (Medtronic MiniMed 670G and 780G System, Tandem t:Slim X2 Control-IQ, and Omnipod 5) on Glycemic Control and Patient-reported Outcomes in People Living With Type 1 Diabetes: a Multicenter Real-world Observational Study and Safety Study in Young Children (2-6 Years Old) in Belgium

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • AZORG
      • Antwerp, Belgium, 2018
        • GZA Ziekenhuizen - campus Sint-Vincentius
      • Antwerp, Belgium, 2020
        • ZAS - pediatrics
      • Arlon, Belgium, 6700
        • Hôpital d'Arlon
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Bruges, Belgium, 8000
        • AZ Sint-Jan
      • Bruges, Belgium, 8000
        • AZ Sint-Jan - pediatrics
      • Brussels, Belgium, 1070
        • Hôpital Erasme
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St. Luc
      • Brussels, Belgium, 1020
        • Hôpital Universitaire des Enfants Reine Fabiola - pediatrics
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St. Luc - pediatrics
      • Charleroi, Belgium, 6000
        • Grand Hôpital de Charleroi - pediatrics
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Edegem, Belgium, 2650
        • UZ Antwerpen - pediatrics
      • Genk, Belgium, 3600
        • ZOL Sint-Jan
      • Ghent, Belgium, 9000
        • Uz Gent
      • Ghent, Belgium, 9000
        • UZ Gent - pediatrics
      • Hasselt, Belgium, 3500
        • Jessa - pediatrics
      • Hasselt, Belgium, 3500
        • Jessa
      • Jette, Belgium, 1090
        • Uz Brussel
      • Jette, Belgium, 1090
        • UZ Brussel - pediatrics
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - campus kennedylaan
      • Liège, Belgium, 4000
        • CHR Citadelle
      • Liège, Belgium, 4000
        • Clinique CHC MontLégia
      • Liège, Belgium, 4000
        • CHU de Liège - site du Sart Tilman
      • Liège, Belgium, 4000
        • Clinique CHC Montlégia - pediatrics
      • Liège, Belgium, 4030
        • CHR Citadelle - pediatrics
      • Maaseik, Belgium, 3680
        • ZOL Maas en Kempen - pediatrics
      • Mons, Belgium, 7000
        • CHU Helora
      • Ostend, Belgium, 8400
        • AZ Oostende
      • Roeselare, Belgium, 8800
        • AZ Delta
      • Roeselare, Belgium, 8800
        • AZ Delta - pediatrics
      • Sint-Niklaas, Belgium, 9100
        • Vitaz
      • Sint-Niklaas, Belgium, 9100
        • Vitaz - pediatrics
      • Turnhout, Belgium, 2300
        • AZ Turnhout - pediatrics
      • Wilrijk, Belgium, 2610
        • GZA Ziekenhuizen - campus Sint-Augustinus
      • Yvoir, Belgium, 5530
        • CHU UCL Namur - pediatrics
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited at 26 diabetes convention hospitals in Belgium

Description

People with type 1 diabetes, aged 7 years and older who start with the Medtronic MiniMed 670G or 780G system, aged 6 years and older who start with the Tandem t:slim X2 Control-IQ or those aged 2 years and older who start with the Omnipod 5 in the participating centers and who signed informed consent or gave informed assent (pediatrics) are eligible to participate. For the safety study, children with type 1 diabetes aged 2-6 years old who start(ed) with the Medtronic MiniMed 780G system in Manual Mode, whose parents agree to enable Auto Mode (after at least 4 weeks of Manual Mode) and whose parents signed informed consent can be included. Auto Mode enablement is only possible if time since type 1 diabetes diagnosis is at least 6 months.

The decision about which person with type 1 diabetes to start, is left to the clinical judgement of the treating health care professional.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time in range
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time in range
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent in range (sensor glucose 70-180 mg/dL), with exclusion of the primary endpoint
from before start to 4, 8, 12 and 24 months after start
Time in level 2 hypoglycemia
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent in level 2 hypoglycemia (sensor glucose <54 mg/dL)
from before start to 4, 8, 12 and 24 months after start
Time in level 1 hypoglycemia
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent in level 1 hypoglycemia (sensor glucose <70 mg/dL and ≥54 mg/dL)
from before start to 4, 8, 12 and 24 months after start
Time below range
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent below range (sensor glucose <70 mg/dL)
from before start to 4, 8, 12 and 24 months after start
Time above range
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent above range (sensor glucose >180 mg/dL)
from before start to 4, 8, 12 and 24 months after start
Glycemic variability
Time Frame: from before start to 4, 8, 12 and 24 months after start
Glycemic variability: coefficient of variation (CV), standard deviation (SD) and mean amplitude of glycemic excursions (MAGE)
from before start to 4, 8, 12 and 24 months after start
Mean glucose concentration
Time Frame: from before start to 4, 8, 12 and 24 months after start
Mean glucose concentration
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))
Time Frame: from before start to 4, 8, 12 and 24 months after start for adults
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))
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"))
Time Frame: from before start to 4, 8, 12 and 24 months after start for adults and children
Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))
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))
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))
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))
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, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
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))
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))
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))
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))
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))
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))
from before start to 4, 8, 12 and 24 months after start for adults
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
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
from before start to 4, 8, 12 and 24 months after start for children
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
The Diabetes Quality of Life for Youth (DQOLY) questionnaire
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)
Time Frame: from before start to 4, 8, 12 and 24 months after start for parents
Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)
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
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
from before start to 4, 8, 12 and 24 months after start for parents
Time in tight range
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent in tight range (sensor glucose 70-140 mg/dL)
from before start to 4, 8, 12 and 24 months after start
Time in level 1 hyperglycemia
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent in level 1 hyperglycemia (sensor glucose ≥180 mg/dL and <250 mg/dL)
from before start to 4, 8, 12 and 24 months after start
Time in level 2 hyperglycemia
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent in level 2 hyperglycemia (sensor glucose >250 mg/dL)
from before start to 4, 8, 12 and 24 months after start
Time above 140 mg/dL
Time Frame: from before start to 4, 8, 12 and 24 months after start
Percentage of time spent >140 mg/dL
from before start to 4, 8, 12 and 24 months after start
HbA1c
Time Frame: from before start to 4, 8, 12 and 24 months after start
HbA1c
from before start to 4, 8, 12 and 24 months after start
Glucose management indicator
Time Frame: from before start to 4, 8, 12 and 24 months after start
Glucose management indicator
from before start to 4, 8, 12 and 24 months after start
Glycemic risk index
Time Frame: from before start to 4, 8, 12 and 24 months after start
Glycemic risk index
from before start to 4, 8, 12 and 24 months after start
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
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))
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)
Time Frame: at 4, 8, 12 and 24 months after start of the Medtronic MiniMed 670G and 780G system for adults and children
Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G/780G system (multiple choice)
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))
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, worry (scale: 0 (not worried) - 60 (very worried))
from before start to 4, 8, 12 and 24 months after start for children

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severe hypoglycemia
Time Frame: from before start to 4, 8, 12 and 24 months after start
Frequency of severe hypoglycemia
from before start to 4, 8, 12 and 24 months after start
Diabetic ketoacidosis
Time Frame: from before start to 4, 8, 12 and 24 months after start
Frequency of diabetic ketoacidosis
from before start to 4, 8, 12 and 24 months after start
Hospital visits and/or admissions
Time Frame: from before start to 4, 8, 12 and 24 months after start
Number of hospital visits and/or admissions because of severe hypoglycemia or diabetic ketoacidosis
from before start to 4, 8, 12 and 24 months after start
Work and school absenteeism
Time Frame: from before start to 4, 8, 12 and 24 months after start
Work and school absenteeism (number of days that a patient was unable to attend work/school due to his/her diabetes (excluding consultation))
from before start to 4, 8, 12 and 24 months after start
(Unplanned) contacts with the diabetes team
Time Frame: from before start to 4, 8, 12 and 24 months after start
Frequency of (unplanned) contacts with the diabetes team
from before start to 4, 8, 12 and 24 months after start
Change in total daily dose of insulin (units/day)
Time Frame: from before start to 4, 8, 12 and 24 months after start
Change in total daily dose of insulin (units/day)
from before start to 4, 8, 12 and 24 months after start
Change in body weight (kilograms)
Time Frame: from before start to 4, 8, 12 and 24 months after start
Change in body weight (kilograms)
from before start to 4, 8, 12 and 24 months after start
Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))
Time Frame: at start
Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))
at start
Patients who stop
Time Frame: only measured at stop
Number of patients who stop with hybrid closed-loop therapy
only measured at stop
Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)
Time Frame: only measured at stop
Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)
only measured at stop
Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
from before start to 12 months after start
Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the DIDP-FM questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the DAWN (Diabetes Attitudes, Wishes and Needs) Impact of Diabetes Profile Family Members (DIDP-FM) questionnaire (scale: 0 (less negative impact) - 100 (more negative impact)) Note: only in case of substudy
from before start to 12 months after start
Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
from before start to 12 months after start
Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the DIDP-FM questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the DIDP-FM questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between 'quality of life of T1D patients using hybrid closed-loop therapy' and 'quality of life in partners of T1D patients', both measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Correlation between 'quality of life of T1D patients using hybrid closed-loop therapy' and 'quality of life in partners of T1D patients', both measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between composite endpoint 'HbA1c and time in hypoglycemia <70 mg/dL' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2. Note: substudy only
Time Frame: from before start to 12 months after start
Correlation between composite endpoint 'HbA1c and time in hypoglycemia <70 mg/dL' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between composite endpoint 'HbA1c and time in hypoglycemia <70 mg/dL' and 'quality of life in partners of T1D patients using the hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: substudy only
Time Frame: from before start to 12 months after start
Correlation between composite endpoint 'HbA1c and time in hypoglycemia <70 mg/dL' and 'quality of life in partners of T1D patients using the hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2. Note: substudy only
Time Frame: from before start to 12 months after start
Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
from before start to 12 months after start
Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
Time Frame: from before start to 12 months after start
Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
from before start to 12 months after start
Time in Manual Mode
Time Frame: only measured at month 4, 8, 12 and 24 after start
Percentage of time spent in Manual Mode
only measured at month 4, 8, 12 and 24 after start
Time in Auto Mode
Time Frame: only measured at month 4, 8, 12 and 24 after start
Percentage of time spent in Auto Mode
only measured at month 4, 8, 12 and 24 after start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pieter Gillard, MD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S63351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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