Clinical trial NCT04414280: The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 1
Keywords: Hybrid closed-loop
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 1150
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited at the Diabetes departments of 17 diabetes convention hospitals in Belgium

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time in range
timeFrame: 12 months
Secondary outcomes:
measure: Time in range
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Time in level 2 hypoglycemia
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Time in level 1 hypoglycemia
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Time below range
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Time above range
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Time in level 1 hyperglycemia
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Glycemic variability
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Mean glucose concentration
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: HbA1c
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Correlation between sex (male/female) and change in HbA1c
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Correlation between educational attainment (measured by a questionnaire with multiple options) and change in HbA1c
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Correlation between cohabitation (yes/no) and change in HbA1c
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Correlation between duration of diabetes (years) and change in HbA1c
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Correlation between chronic diabetic complications (measured by a questionnaire with multiple options) and change in HbA1c
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Correlation between total daily dose of insulin (units per day) and change in HbA1c
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Number of low glucose events
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: 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))
timeFrame: from before start to 4, 8, 12 and 24 months after start for adults
measure: Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))
timeFrame: from before start to 4, 8, 12 and 24 months after start for adults and children
measure: Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))
timeFrame: from before start to 4, 8, 12 and 24 months after start for adults and children
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
timeFrame: from before start to 4, 8, 12 and 24 months after start for adults
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
timeFrame: from before start to 4, 8, 12 and 24 months after start for adults
measure: Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
timeFrame: from before start to 4, 8, 12 and 24 months after start for adults
measure: Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))
timeFrame: from before start to 4, 8, 12 and 24 months after start for adults
measure: Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G system (multiple choice)
timeFrame: at 4, 8, 12 and 24 months after start of the Medtronic MiniMed 670G and 780G system for adults and children
measure: 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))
timeFrame: from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for adults
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))
timeFrame: from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for children
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
timeFrame: from before start to 4, 8, 12 and 24 months after start for children
measure: The Diabetes Quality of Life for Youth (DQOLY) questionnaire
timeFrame: from before start to 4, 8, 12 and 24 months after start for children
measure: Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)
timeFrame: from before start to 4, 8, 12 and 24 months after start for parents
measure: The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents
timeFrame: from before start to 4, 8, 12 and 24 months after start for parents
Other outcomes:
measure: Composite endpoint of HbA1c and time in hypoglycemia <70 mg/dl
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Severe hypoglycemia
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Diabetic ketoacidosis
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Hospital visits and/or admissions
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Work and school absenteeism
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: (Unplanned) contacts with the diabetes team
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Change in total daily dose of insulin (units/day)
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Change in body weight (kilograms)
timeFrame: from before start to 4, 8, 12 and 24 months after start
measure: Time in Manual Mode
timeFrame: only measured at month 4, 8, 12 and 24 after start of the Medtronic MiniMed 670G an 780G system
measure: Time in Auto Mode
timeFrame: only measured at month 4, 8, 12 and 24 after start of the Medtronic MiniMed 670G an 780G system
measure: Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))
timeFrame: at start
measure: Patients who stop
timeFrame: only measured at stop
measure: Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)
timeFrame: only measured at stop
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
measure: 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
timeFrame: from before start to 12 months after start
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Aalst
country: Belgium
facility: OLVZ Aalst
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen - campus Sint-Vincentius
city: Arlon
country: Belgium
facility: Hôpital d'Arlon
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brugge
country: Belgium
facility: AZ Sint-Jan - campus Sint-Jan
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Genk
country: Belgium
facility: ZOL - campus Sint-Jan
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - campus Salvator
city: Jette
country: Belgium
facility: UZ Brussel
city: Kortrijk
country: Belgium
facility: AZ Groeninge - campus kennedylaan
city: Liège
country: Belgium
facility: CHR de La Citadelle
city: Liège
country: Belgium
facility: CHU de Liège - site du Sart Tilman
city: Oostende
country: Belgium
facility: Az Damiaan
city: Roeselare
country: Belgium
facility: AZ Delta - campus Wilgenstraat Roeselare
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen - campus Sint-Augustinus
Study officials:
affiliation: UZ Leuven
name: Pieter Gillard, MD
role: PRINCIPAL_INVESTIGATOR
References: