Diabetes Mellitus, Type 1
Conditions
Keywords
hybrid closed-loop therapy, real-world, automated insulin delivery
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.
Interventions
DEVICEMedtronic 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.
DEVICEMedtronic 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.
DEVICETandem 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.
DEVICEOmnipod 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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 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
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 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 |
| Time in tight range | 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) |
| Time in level 2 hypoglycemia | 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) |
| Time in level 1 hypoglycemia | 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) |
| Time below range | from before start to 4, 8, 12 and 24 months after start | Percentage of time spent below range (sensor glucose \<70 mg/dL) |
| Time above range | from before start to 4, 8, 12 and 24 months after start | Percentage of time spent above range (sensor glucose \>180 mg/dL) |
| Time in level 1 hyperglycemia | 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) |
| Time in level 2 hyperglycemia | 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) |
| Time above 140 mg/dL | from before start to 4, 8, 12 and 24 months after start | Percentage of time spent \>140 mg/dL |
| HbA1c | from before start to 4, 8, 12 and 24 months after start | HbA1c |
| Mean glucose concentration | from before start to 4, 8, 12 and 24 months after start | Mean glucose concentration |
| Glycemic variability | 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) |
| Glucose management indicator | from before start to 4, 8, 12 and 24 months after start | Glucose management indicator |
| Glycemic risk index | from before start to 4, 8, 12 and 24 months after start | Glycemic risk index |
| 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 | 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)) |
| 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 Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (\<4 times "R")) |
| 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 | Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware)) |
| 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, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour)) |
| 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 | Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried)) |
| 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 | Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed)) |
| 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 the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction)) |
| 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 | 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)) |
| 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 | Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G/780G system (multiple choice) |
| 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 | 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, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour)) | 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)) |
| The Diabetes Quality of Life for Youth (DQOLY) questionnaire | from before start to 4, 8, 12 and 24 months after start for children | The Diabetes Quality of Life for Youth (DQOLY) questionnaire |
| 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 | Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes) |
| 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 | The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORPieter Gillard, MD
UZ Leuven
Outcome results
None listed