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

Diabetes Mellitus Type 2 With Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461716
• Other study ID #: 857223-UC3GR
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2022
• Source: University of Thessaly
• Contact: George E, Dafoulas
• Phone: +306957830903
• Email: gdafoulas[@]med.uth.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 With Hypoglycemia
• Diabetes Mellitus, Type 2
• Hypoglycemia

Intervention

Device:
• periodic use of Continuous Glucose Monitoring (CGM)
Identification of hypoglycaemia events, based on use of Continuous Glucose Monitoring (CGM) for at least 14days, in subgroups of T2DM patients with high risk of hypoglycaemia

Locations

Country	Name	City	State
Greece	Department of Endocrinology and Metabolic Diseases, University Hospital of Larisa	Larissa	Thessaly

Sponsors (3)

Lead Sponsor	Collaborator
George E. Dafoulas	Centre for Research and Technology Hellas, University of Ioannina

Country where clinical trial is conducted

Greece, 

References & Publications (2)

Pazos-Couselo M, García-López JM, González-Rodríguez M, Gude F, Mayán-Santos JM, Rodríguez-Segade S, Rodríguez-García 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of hypoglycaemic events		frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Secondary	Glucose Management Indicator (GMI) correlation with HbA1c		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Secondary	Glycaemic control (Time in Range)		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Secondary	EQ5D (Generic HRQL)	Generic Health Related Quality of Life (HRQL)	12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Secondary	Problem Areas in Diabetes scale - PAID (Disease specific HRQL)		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Secondary	Assess the risk of hypoglycemia with Hypoglycemia Patient Questionnaire		12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Secondary	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