The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: Tandem Control-IQDevice: Medtronic MiniMed 670GDevice: Medtronic MiniMed 780G
- Registration Number
- NCT04414280
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1150
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description type 1 diabetes patients using Tandem Control-IQ Tandem Control-IQ 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. type 1 diabetes patients using Medtronic MiniMed 670G Medtronic MiniMed 670G 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. type 1 diabetes patients using Medtronic MiniMed 780G Medtronic MiniMed 780G 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method HbA1c from before start to 4, 8, 12 and 24 months after start Change in HbA1c
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)
Number of low glucose events from before start to 4, 8, 12 and 24 months after start 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)
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 \>250 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)
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, worry (scale: 0 (not worried) - 60 (very worried))
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 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)
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 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))
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
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)
Mean glucose concentration from before start to 4, 8, 12 and 24 months after start Mean glucose concentration
Correlation between sex (male/female) and 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 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 educational attainment (measured by a questionnaire with multiple options) 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 cohabitation (yes/no) 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 duration of diabetes (years) 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 chronic diabetic complications (measured by a questionnaire with multiple options) 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 Correlation between total daily dose of insulin (units per day) and change in HbA1c
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))
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)
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"))
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))
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))
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))
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 Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G system (multiple choice)
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 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
Trial Locations
- Locations (18)
AZ Groeninge - campus kennedylaan
🇧🇪Kortrijk, Belgium
CHR de La Citadelle
🇧🇪Liège, Belgium
CHU de Liège - site du Sart Tilman
🇧🇪Liège, Belgium
Az Damiaan
🇧🇪Oostende, Belgium
AZ Delta - campus Wilgenstraat Roeselare
🇧🇪Roeselare, Belgium
GZA Ziekenhuizen - campus Sint-Augustinus
🇧🇪Wilrijk, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
Imeldaziekenhuis
🇧🇪Bonheiden, Belgium
ZOL - campus Sint-Jan
🇧🇪Genk, Belgium
Jessa Ziekenhuis - campus Salvator
🇧🇪Hasselt, Belgium
UZ Brussel
🇧🇪Jette, Belgium
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium
OLVZ Aalst
🇧🇪Aalst, Belgium
GZA Ziekenhuizen - campus Sint-Vincentius
🇧🇪Antwerpen, Belgium
Hôpital d'Arlon
🇧🇪Arlon, Belgium
AZ Sint-Jan - campus Sint-Jan
🇧🇪Brugge, Belgium
Hôpital Erasme
🇧🇪Bruxelles, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium