Secondary Care - Continuous Glucose Monitoring (SC-COSMO)

Continuous Glucose Monitoring in Patients With Diabetes Mellitus Type 2 in Secondary Care

Introduction and objective: The current state of glucose monitoring includes the use of A1C, self-monitoring of blood glucose (SMBG), and continuous glucose monitoring (CGM). CGM technology has got the potential to revolutionize diabetes care in the near future striving to optimal diabetes management and tight glucose control. Until very recently, this determination could only be achieved by the attainment of multiple capillary blood glucose determinations each day and/or measuring hemoglobin A1C. Those methods are not accurate in cases of unrecognized hypoglycemia, unrecognized nighttime events or in cases of large swings in blood glucose. Our aim is to analyze the benefit of tracking patterns of glucose values by using professional CGM technology used for "blinded" collection of glucose data retrospectively in patients with T2DM in secondary care- diabetologist clinic.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: continuous glucose monitoring (CGM) iPro™2 Medtronic

Detailed Description

STUDY DESIGN: An observational, multicenter, cross-sectional study. A total of 20 diabetologist from four Croatian regions will recruit up to ten subjects of both sexes from May 2018 till the end of May 2019, diagnosed with type 2 diabetes mellitus at least one year prior to study entry, aged ≥40 years, with only basal insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and hemoglobin A1c findings. Sociodemographic, laboratory (HbA1c, fasting and postprandial glucose, total cholesterol, and high density cholesterol, and low density cholesterol, triglyceride and serum creatinine) and habits data will be collected.

SETTING: Totally 100 of patients will be included. At diabetologist office each patient wear the device (iPro™2 Medtronic) subcutaneously for up to 7-days and return it to the office for download. Patients only see the CGM data after it's been analyzed by the healthcare professional. A CGM device is to be set and take off by the diabetologist. Before the study start all diabetologist who are not familiar to the method will have a short education. Study period is seven days and includes screening before study entry and two visits. On Day 1, after screening and signing the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary with four daily standard SMBG along with the data on eating, physical exercise, drugs. On Day 7, CGM device is taken off and the data from iPro2 is uploaded to PC. At the end, each patient fills a short query on satisfaction while wearing CGM.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10 000
    • University Hospital Centre Zagreb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days to 1 week (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Totally 100 of patients with type 2 diabetes mellitus diagnosed at least one year prior to study entry, aged ≥40 years, both sexes, treated in secondary care, with no insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and A1C findings will be included.

Description

Inclusion Criteria:

• T2DM diagnosed at least one year prior to study entry
• Only basal insulin in therapy
• Patients' ability to understand and answer the questionnaire by themselves
• Signed informed consent

Exclusion Criteria:

• Known coagulopathy
• Oral anticoagulants in therapy
• Skin disease that enables continuous glucose monitor device application
• Febrile illness
• Patient's inability to physically visit a general practitioners office
• Patient's inability to answer the questionnaire by themselves

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic variability	Glycemic variability measured by continuous glucose monitor devicein individuals with type 2 diabetes mellitus in secondary care	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypogliaemia	Hypogliaemia measured by continuous glucose monitor device in individuals with type 2 diabetes mellitus in secondary care	7 days

Collaborators and Investigators

• Sponsor: Croatian Society for Endocrinology and Diabology
• Collaborators: Takeda

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2018
• Primary Completion (ACTUAL): August 25, 2021
• Study Completion (ACTUAL): August 25, 2021

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (ACTUAL): April 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 11, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: hypoglycemia; continuous glucose monitoring; glycemic variability
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Program CGM u bolesnika T2DM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No