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Completed

NCT Number: NCT02601729

Reimbursement Study of Continuous Glucose Monitoring in Belgium

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.

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Key information

Conditions

Diabetes, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evolution over time of HbA1c

    Time frame: between 12 months before and 24 months after start RT-CGM

Secondary outcomes

  1. The number of hospitalizations because of hypoglycemia and/or ketoacidosis

    Time frame: between 12 months before and 24 months after start RT-CGM

  2. The number of severe hypoglycemic events

    Time frame: between 12 months before and 24 months after start RT-CGM

  3. The number of hypoglycemic coma

    Time frame: between 12 months before and 24 months after start RT-CGM

  4. The number of hypoglycemia with seizure

    Time frame: between 12 months before and 24 months after start RT-CGM

  5. The number of hypoglycemia with need of glucagon

    Time frame: between 12 months before and 24 months after start RT-CGM

  6. The number of hypoglycemic events needing help from ambulance personnel

    Time frame: between 12 months before and 24 months after start RT-CGM

  7. Change in utilization of RT-CGM (= % use of RT-CGM)

    Time frame: between 12 months before and 24 months after start RT-CGM

  8. Number of days absent from on work or school

    Time frame: between 12 months before and 24 months after start RT-CGM

  9. Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire for adults

    Time frame: between start of RT-CGM and 24 months after start RT-CGM

    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))

  10. Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry for adults

    Time frame: between start of RT-CGM and 24 months after start RT-CGM

    Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 52 (very worried))

  11. Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire for adults

    Time frame: between start of RT-CGM and 24 months after start RT-CGM

    Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))

  12. Quality of life measured by the Diabetes Quality of Life for Youth for children

    Time frame: between start of RT-CGM and 24 months after start RT-CGM

    Quality of life measured by the Diabetes Quality of Life for Youth

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Clinical Impact of RT-CGM Reimbursement in Belgium: a Multicenter Real-life Observational Study

Acronym: RESCUE

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 10, 2015
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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