Clinical trial NCT02601729: Reimbursement Study of Continuous Glucose Monitoring in Belgium
Official title: Clinical Impact of RT-CGM Reimbursement in Belgium: a Multicenter Real-life Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes, Type 1
Keywords: Type 1 diabetes
real-time continuous glucose monitoring
observational study
insulin pump
Belgium
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 589
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selected group of type 1 diabetic patients by means of a so-called "CGM convention". In order to be a candidate for reimbursement, patients have to be on an insulin pump and use their RT-CGM device for more than 70 % of the time (see www.riziv.be, Nota CGV 2014/228). Reimbursement via the RT-CGM reimbursement system has been granted for an initial period of three years. As part of the requirements of the current reimbursement system, the Belgian health care authorities demanded for an evaluation after 2 years.

Brief summary: Type 1 diabetes mellitus (T1DM) is an autoimmune disease caused by an immune mediated destruction of the pancreatic β-cells. Once the pancreas has been depleted of a critical mass of β-cells the need for exogenous insulin therapy emerges. Several methods exist to administer insulin. An alternative way to administer insulin is by means of continuous subcutaneous insulin infusions (CSII) or insulin-pump therapy.The frequent execution of self-monitoring of blood glucose (SMBG) accomplished by a capillary finger-stick test is essential in the management of diabetes, but this is very limited and also lacks information about rising or falling trends in the actual glycaemia. A solution for this is the use of a Real-Time Continuous Glucose Monitoring (RT-CGM) device. Contrary to SMBG, RT-CGM measures glycaemia 24 hours a day, provides information about glucose direction and rate of change during multiple days a week. Since September 2014, RT-CGM is reimbursed in Belgium for a selected group of type 1 diabetic patients by means of a so-called "CGM convention". The main objective of the study is to evaluate the impact of real time continuous glucose monitoring reimbursement on real-life clinical care parameters of type 1 diabetic patients in Belgium after 12 and 24 months.


Eligibility criteria: Inclusion Criteria:

* Patients with T1DM included in the RT-CGM reimbursement system and followed in one of 17 diabetes centers.

Exclusion Criteria:

* Patients who are not included in the RT-CGM reimbursement system.

Primary outcomes:
measure: Evolution over time of HbA1c
timeFrame: between 12 months before and 24 months after start RT-CGM
Secondary outcomes:
measure: The number of hospitalizations because of hypoglycemia and/or ketoacidosis
timeFrame: between 12 months before and 24 months after start RT-CGM
measure: The number of severe hypoglycemic events
timeFrame: between 12 months before and 24 months after start RT-CGM
measure: The number of hypoglycemic coma
timeFrame: between 12 months before and 24 months after start RT-CGM
measure: The number of hypoglycemia with seizure
timeFrame: between 12 months before and 24 months after start RT-CGM
measure: The number of hypoglycemia with need of glucagon
timeFrame: between 12 months before and 24 months after start RT-CGM
measure: The number of hypoglycemic events needing help from ambulance personnel
timeFrame: between 12 months before and 24 months after start RT-CGM
measure: Change in utilization of RT-CGM (= % use of RT-CGM)
timeFrame: between 12 months before and 24 months after start RT-CGM
measure: Number of days absent from on work or school
timeFrame: between 12 months before and 24 months after start RT-CGM
measure: Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire for adults
timeFrame: between start of RT-CGM and 24 months after start RT-CGM
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry for adults
timeFrame: between start of RT-CGM and 24 months after start RT-CGM
measure: Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire for adults
timeFrame: between start of RT-CGM and 24 months after start RT-CGM
measure: Quality of life measured by the Diabetes Quality of Life for Youth for children
timeFrame: between start of RT-CGM and 24 months after start RT-CGM
Other outcomes:
Locations:
Study officials:
References:
citation: De Ridder F, Charleer S, Jacobs S, Bolsens N, Ledeganck KJ, Van Aken S, Vanbesien J, Gies I, Casteels K, Massa G, Lysy PA, Logghe K, Lebrethon MC, Depoorter S, Gillard P, De Block C, den Brinker M. Effect of nationwide reimbursement of real-time continuous glucose monitoring on HbA1c, hypoglycemia and quality of life in a pediatric type 1 diabetes population: The RESCUE-pediatrics study. Front Pediatr. 2022 Oct 6;10:991633. doi: 10.3389/fped.2022.991633. eCollection 2022.
citation: Charleer S, De Block C, Nobels F, Radermecker RP, Lowyck I, Mullens A, Scarniere D, Spincemaille K, Strivay M, Weber E, Taes Y, Vercammen C, Keymeulen B, Mathieu C, Gillard P; RESCUE Trial Investigators. Sustained Impact of Real-time Continuous Glucose Monitoring in Adults With Type 1 Diabetes on Insulin Pump Therapy: Results After the 24-Month RESCUE Study. Diabetes Care. 2020 Dec;43(12):3016-3023. doi: 10.2337/dc20-1531. Epub 2020 Oct 16.
citation: Charleer S, Mathieu C, Nobels F, De Block C, Radermecker RP, Hermans MP, Taes Y, Vercammen C, T'Sjoen G, Crenier L, Fieuws S, Keymeulen B, Gillard P; RESCUE Trial Investigators. Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1224-1232. doi: 10.1210/jc.2017-02498.