Clinical trial NCT05461716: Incidence of Hypoglycaemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring
Official title: Incidence of Hypoglycemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus: Continuous Glucose Monitoring vs. Self-Monitored Blood Glucose
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus Type 2 With Hypoglycemia
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: Centre for Research and Technology Hellas
name: University of Ioannina
First posted: 2022-07-18
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from the Primary Care Services or the Outpatient Department of the Hospital

Brief 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Detection of hypoglycaemic events
timeFrame: frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Secondary outcomes:
measure: Glucose Management Indicator (GMI) correlation with HbA1c
timeFrame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
measure: Glycaemic control (Time in Range)
timeFrame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
measure: EQ5D (Generic HRQL)
timeFrame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
measure: Problem Areas in Diabetes scale - PAID (Disease specific HRQL)
timeFrame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
measure: Assess the risk of hypoglycemia with Hypoglycemia Patient Questionnaire
timeFrame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
measure: Registry of hypoglycaemia events in patients with T2DM treated with insulin and insulin secretagogues
timeFrame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Department of Endocrinology and Metabolic Diseases, University Hospital of Larisa
state: Thessaly
Study officials:
References:
citation: 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.
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.