NCT05461716

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

12 months

First QC Date

July 12, 2022

Last Update Submit

July 13, 2022

Conditions

Diabetes Mellitus Type 2 With Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Detection of hypoglycaemic events

    frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks

Secondary Outcomes (6)

  • 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)

    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

  • +1 more secondary outcomes

Interventions

periodic use of Continuous Glucose Monitoring (CGM)DEVICE

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology and Metabolic Diseases, University Hospital of Larisa

Larissa, Thessaly, 41110, Greece

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26254702BACKGROUND

  • 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.

    PMID: 23589542BACKGROUND

Central Study Contacts

George E, Dafoulas

CONTACT

+306957830903gdafoulas@med.uth.gr

Alexandra Bargiota

CONTACT

abargio@med.uth.gr

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 18, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

The IPD are going to be shared within the provisions of the European Commission Grant Agreement and Consortium Agreement of the Study

Locations

GR(1)