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NCT Number: NCT04414280

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven, Leuven, Vlaams-Brabant, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medtronic MiniMed 670G

Device

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 780G

Device

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-IQ

Device

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.

OmniPod 5

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. HbA1c

    Time frame: from before start to 4, 8, 12 and 24 months after start

    HbA1c

  11. Mean glucose concentration

    Time frame: from before start to 4, 8, 12 and 24 months after start

    Mean glucose concentration

  12. 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)

  13. Glucose management indicator

    Time frame: from before start to 4, 8, 12 and 24 months after start

    Glucose management indicator

  14. Glycemic risk index

    Time frame: from before start to 4, 8, 12 and 24 months after start

    Glycemic risk index

  15. 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))

  16. 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"))

  17. 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))

  18. 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))

  19. 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))

  20. 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))

  21. 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))

  22. 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))

  23. 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)

  24. 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))

  25. 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))

  26. 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

  27. 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)

  28. 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

Other outcomes

  1. Severe hypoglycemia

    Time frame: from before start to 4, 8, 12 and 24 months after start

    Frequency of severe hypoglycemia

  2. Diabetic ketoacidosis

    Time frame: from before start to 4, 8, 12 and 24 months after start

    Frequency of diabetic ketoacidosis

  3. 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

  4. 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))

  5. (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

  6. 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)

  7. Change in body weight (kilograms)

    Time frame: from before start to 4, 8, 12 and 24 months after start

    Change in body weight (kilograms)

  8. Time in Manual Mode

    Time frame: only measured at month 4, 8, 12 and 24 after start

    Percentage of time spent in Manual Mode

  9. Time in Auto Mode

    Time frame: only measured at month 4, 8, 12 and 24 after start

    Percentage of time spent in Auto Mode

  10. 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))

  11. Patients who stop

    Time frame: only measured at stop

    Number of patients who stop with hybrid closed-loop therapy

  12. 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)

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: INRANGE

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jun 4, 2020
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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