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Diabetes, Type 1RESCUENCT02601729

Reimbursement Study of Continuous Glucose Monitoring in Belgium

An observational study of Diabetes, Type 1, run by KU Leuven.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes, Type 1
How many people
589 participants
Where
No sites listed yet
Study dates
Sep 2014to 18 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

About this study

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

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.

Keywords
Type 1 diabetes, real-time continuous glucose monitoring, observational study, insulin pump, Belgium
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02601729
Study groupRoleWhat they receive
RT-CGM populationProspective data collection during standardized clinical follow-up and from filled out questionnaires.
Pump only populationRetrospective data collection on demographic and clinical characteristics.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evolution over time of HbA1c

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

Secondary outcomes (12)

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

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

  2. The number of severe hypoglycemic events

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

  3. The number of hypoglycemic coma

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

  4. The number of hypoglycemia with seizure

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

  5. The number of hypoglycemia with need of glucagon

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

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

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

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

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

  8. Number of days absent from on work or school

    Measured: 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

    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))

    Measured: between start of RT-CGM and 24 months after start RT-CGM

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

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

    Measured: between start of RT-CGM and 24 months after start RT-CGM

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

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

    Measured: between start of RT-CGM and 24 months after start RT-CGM

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

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

    Measured: between start of RT-CGM and 24 months after start RT-CGM

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2015 (estimated)
  2. Study startSep 2014
  3. Primary completion18 Jan 2019
  4. Study completion18 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02601729
Sponsor's protocol ID
CGM-RESCUE
Acronym
RESCUE
Status last verified
Jun 2020
First submitted
9 Nov 2015
Last updated
22 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • Aernouts C, Belde SPW, Lambrechts J, Mertens J, Ledeganck KJ, Francque SM, De Block CEM. Metabolic dysfunction-associated steatotic liver disease is associated with worse time in ranges in type 1 diabetes. Diabetes Obes Metab. 2024 Sep;26(9):3781-3790. doi: 10.1111/dom.15723. Epub 2024 Jun 25.

    PubMed 38924290

  • 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.

    PubMed 38787436

  • 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.

    PubMed 36275049

  • 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.

    PubMed 33067260

  • 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.

    PubMed 29342264

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, Type 1, run by KU Leuven.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution over time of HbA1c (time frame: between 12 months before and 24 months after start RT-CGM). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02601729, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.

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