Incidence of Hypoglycaemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring

Incidence of Hypoglycemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus: Continuous Glucose Monitoring vs. Self-Monitored Blood Glucose

Certain groups of patients with Type 2 Diabetes Mellitus (T2DM) appear to have higher risk of hypoglycaemia. Periodic use of Continuous Glucose Monitoring (CGM), has been suggested as a method to detect hypoglycaemia events in certain subgroups of patients with high risk of hypoglycaemia.

The aim of the present study is to contribute to the identification of subgroups of T2DM patients with high risk of hypoglycemia events, based on periodic use of Continuous Glucose Monitoring (CGM).

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus Type 2 With Hypoglycemia
• Intervention / Treatment: Device: periodic use of Continuous Glucose Monitoring (CGM)

Detailed Description

Some studies successfully achieved standard glycemic targets without increased hypoglycaemia in older adults and other groups of patients with high risk of hypoglycaemia events.

However these trials usually exclude adults with poor health and comorbidities, when they support the concept that intensive strategies for selected individuals can be effective and safe. The compendium of results from these and other published analyses suggests that although some patients may benefit from tighter targets, many are unable to reach these targets, and aggressive therapy may be harmful to some patients without the benefit of reducing complications.

Although avoidance of hypoglycaemia is a critical treatment strategy, overall glucose control remains an important goal. The present treatment guidelines fail to locate the proper subgroup of patients with Type 2 Diabetes Mellitus (T2DM), that could be benefited of glycemic control balanced with the adverse effects of glucose-lowering medications and a patient's age, overall health status, and functional and intellectual capacity. The aim of the present study is to contribute to the identification of subgroups of T2DM patients with high risk of hypoglycemia events, based on periodic use of Continuous Glucose Monitoring (CGM).

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: George E, Dafoulas; Phone Number: +306957830903; Email: gdafoulas@med.uth.gr
• Study Contact Backup: Name: Alexandra Bargiota; Email: abargio@med.uth.gr

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • Recruiting
      • Department of Endocrinology and Metabolic Diseases, University Hospital of Larisa
      • Contact: Alexandra Bargiota; Email: abargio@med.uth.gr
      • Contact: George E. Dafoulas; Phone Number: +306957830903; Email: gdafoulas@med.uth.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients from the Primary Care Services or the Outpatient Department of the Hospital

Description

Inclusion Criteria:

• being older than 40 years of age
• having type 2 diabetes for at least 1 year
• being on insulin therapy for at least 3 months before recruitment
• having the ability to perform self-monitoring
• being able to wear a CGM system during 2 weeks
• having a stable metabolic situation, defined as having no need to add new treatments or make any changes in insulin dosage of more than 10% in the preceding 2 months

Exclusion Criteria:

• Having severe hearing or vision problems or any other acute or chronic condition that would limit the ability of the user to participate in the study
• Being institutionalised or person not capable of giving consent
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection of hypoglycaemic events	frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Management Indicator (GMI) correlation with HbA1c		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Glycaemic control (Time in Range)		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
EQ5D (Generic HRQL)	Generic Health Related Quality of Life (HRQL)	12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Problem Areas in Diabetes scale - PAID (Disease specific HRQL)		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Assess the risk of hypoglycemia with Hypoglycemia Patient Questionnaire		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Registry of hypoglycaemia events in patients with T2DM treated with insulin and insulin secretagogues		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks

Collaborators and Investigators

• Sponsor: George E. Dafoulas
• Collaborators: University of Ioannina; Centre for Research and Technology Hellas

Publications and helpful links

General Publications

• Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013 May;36(5):1384-95. doi: 10.2337/dc12-2480. Epub 2013 Apr 15.
• Pazos-Couselo M, Garcia-Lopez JM, Gonzalez-Rodriguez M, Gude F, Mayan-Santos JM, Rodriguez-Segade S, Rodriguez-Garcia J, Casanueva F. High incidence of hypoglycemia in stable insulin-treated type 2 diabetes mellitus: continuous glucose monitoring vs. self-monitored blood glucose. Observational prospective study. Can J Diabetes. 2015 Oct;39(5):428-33. doi: 10.1016/j.jcjd.2015.05.007. Epub 2015 Aug 5.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
• Other Study ID Numbers: 857223-UC3GR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The IPD are going to be shared within the provisions of the European Commission Grant Agreement and Consortium Agreement of the Study

Drug and device information, study documents

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