Reimbursement Study of Continuous Glucose Monitoring in Belgium

NCT02601729 | Completed

• 1 other identifier: CGM-RESCUE
• Study Type: observational
• Target: 589
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes, Type 1

Keywords

Type 1 diabetes; real-time continuous glucose monitoring; observational study; insulin pump; Belgium

Outcome Measures

Primary Outcomes (1)

• Evolution over time of HbA1c

  between 12 months before and 24 months after start RT-CGM

Secondary Outcomes (12)

• The number of hospitalizations because of hypoglycemia and/or ketoacidosis

  between 12 months before and 24 months after start RT-CGM

• The number of severe hypoglycemic events

  between 12 months before and 24 months after start RT-CGM

• The number of hypoglycemic coma

  between 12 months before and 24 months after start RT-CGM

• The number of hypoglycemia with seizure

  between 12 months before and 24 months after start RT-CGM

• The number of hypoglycemia with need of glucagon

  between 12 months before and 24 months after start RT-CGM

Study Arms (2)

RT-CGM population

Prospective data collection during standardized clinical follow-up and from filled out questionnaires.

Pump only population

Retrospective data collection on demographic and clinical characteristics.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead

Related Publications (4)

• De Meulemeester J, Charleer S, Visser MM, De Block C, Mathieu C, Gillard P. The association of chronic complications with time in tight range and time in range in people with type 1 diabetes: a retrospective cross-sectional real-world study. Diabetologia. 2024 Aug;67(8):1527-1535. doi: 10.1007/s00125-024-06171-y. Epub 2024 May 24.

  PMID: 38787436 DERIVED

• 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.

  PMID: 36275049 DERIVED

• 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.

  PMID: 33067260 DERIVED

• 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.

  PMID: 29342264 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Pieter Gillard

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 10, 2015
• Study Start: September 1, 2014
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06