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

Diabetes Mellitus, Type 1 Clinical Trial

— INRANGE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414280
• Other study ID #: S63351
• Status: Recruiting
• Start date: March 12, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Margaretha M Visser, MD
• Phone: +3216345977
• Email: margaretha.visser[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Medtronic 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.
• Medtronic 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.
• Tandem 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.

Locations

Country	Name	City	State
Belgium	OLVZ Aalst	Aalst
Belgium	GZA Ziekenhuizen - campus Sint-Vincentius	Antwerpen
Belgium	Hôpital d'Arlon	Arlon
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	AZ Sint-Jan - campus Sint-Jan	Brugge
Belgium	Hôpital Erasme	Bruxelles
Belgium	UZ Antwerpen	Edegem
Belgium	ZOL - campus Sint-Jan	Genk
Belgium	Jessa Ziekenhuis - campus Salvator	Hasselt
Belgium	UZ Brussel	Jette
Belgium	AZ Groeninge - campus kennedylaan	Kortrijk
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
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	AZ Nikolaas	Sint-Niklaas
Belgium	GZA Ziekenhuizen - campus Sint-Augustinus	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite endpoint of HbA1c and time in hypoglycemia <70 mg/dl	Composite endpoint of HbA1c and time in hypoglycemia <70 mg/dl	from before start to 4, 8, 12 and 24 months after start
Other	Severe hypoglycemia	Frequency of severe hypoglycemia	from before start to 4, 8, 12 and 24 months after start
Other	Diabetic ketoacidosis	Frequency of diabetic ketoacidosis	from before start to 4, 8, 12 and 24 months after start
Other	Hospital visits and/or admissions	Number of hospital visits and/or admissions because of severe hypoglycemia or diabetic ketoacidosis	from before start to 4, 8, 12 and 24 months after start
Other	Work and school absenteeism	Work and school absenteeism (number of days that a patient was unable to attend work/school due to his/her diabetes (excluding consultation))	from before start to 4, 8, 12 and 24 months after start
Other	(Unplanned) contacts with the diabetes team	Frequency of (unplanned) contacts with the diabetes team	from before start to 4, 8, 12 and 24 months after start
Other	Change in total daily dose of insulin (units/day)	Change in total daily dose of insulin (units/day)	from before start to 4, 8, 12 and 24 months after start
Other	Change in body weight (kilograms)	Change in body weight (kilograms)	from before start to 4, 8, 12 and 24 months after start
Other	Time in Manual Mode	Percentage of time spent in Manual Mode	only measured at month 4, 8, 12 and 24 after start of the Medtronic MiniMed 670G an 780G system
Other	Time in Auto Mode	Percentage of time spent in Auto Mode	only measured at month 4, 8, 12 and 24 after start of the Medtronic MiniMed 670G an 780G system
Other	Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))	Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))	at start
Other	Patients who stop	Number of patients who stop with hybrid closed-loop therapy	only measured at stop
Other	Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)	Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)	only measured at stop
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Other	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	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	from before start to 12 months after start
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean glucose concentration	Mean glucose concentration	from before start to 4, 8, 12 and 24 months after start
Secondary	HbA1c	Change in HbA1c	from before start to 4, 8, 12 and 24 months after start
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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