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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Medtronic MiniMed 670G
* Device: Medtronic MiniMed 780G
* Device: Tandem Control-IQ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 1 diabetes patients using Medtronic MiniMed 670G<br>Patients 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 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional. | Device: Medtronic MiniMed 670G<br>* 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.<br>|
| type 1 diabetes patients using Medtronic MiniMed 780G<br>Patients with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 780G system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional. | Device: Medtronic MiniMed 780G<br>* 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.<br>|
| type 1 diabetes patients using Tandem Control-IQ<br>Patients 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 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional. | Device: Tandem Control-IQ<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in range | 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 | 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 | 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 | 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 | Percentage of time spent above range (sensor glucose >180 mg/dL) | 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 >250 mg/dL) | 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) | from before start to 4, 8, 12 and 24 months after start | 
| Mean glucose concentration | Mean glucose concentration | from before start to 4, 8, 12 and 24 months after start | 
| HbA1c | Change in HbA1c | from before start to 4, 8, 12 and 24 months after start | 
| Correlation between sex (male/female) and change in HbA1c | Correlation between sex (male/female) and change in HbA1c | from before start to 4, 8, 12 and 24 months after start | 
| Correlation between educational attainment (measured by a questionnaire with multiple options) and change in HbA1c | Correlation between educational attainment (measured by a questionnaire with multiple options) and change in HbA1c | from before start to 4, 8, 12 and 24 months after start | 
| Correlation between cohabitation (yes/no) and change in HbA1c | Correlation between cohabitation (yes/no) and change in HbA1c | from before start to 4, 8, 12 and 24 months after start | 
| Correlation between duration of diabetes (years) and change in HbA1c | Correlation between duration of diabetes (years) and change in HbA1c | from before start to 4, 8, 12 and 24 months after start | 
| Correlation between chronic diabetic complications (measured by a questionnaire with multiple options) and change in HbA1c | Correlation between chronic diabetic complications (measured by a questionnaire with multiple options) and change in HbA1c | from before start to 4, 8, 12 and 24 months after start | 
| Correlation between total daily dose of insulin (units per day) and change in HbA1c | Correlation between total daily dose of insulin (units per day) and change in HbA1c | from before start to 4, 8, 12 and 24 months after start | 
| Number of low glucose events | Number of low glucose events (LGE, defined as sensor glucose values ≤54 mg/dL for at least 15 minutes, preceded by at least 30 minutes with sensor glucose values >54 mg/dL) | 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)) | 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)) | 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)) | 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)) | 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)) | 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)) | 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)) | 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 system (multiple choice) | Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G system (multiple choice) | at 4, 8, 12 and 24 months after start of the Medtronic MiniMed 670G and 780G system for adults and children | 
| 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)) | from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for adults | 
| 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)) | from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ 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)) | 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 | 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) | 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 | from before start to 4, 8, 12 and 24 months after start for parents | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hybrid closed-loop