Diabetes Mellitus Type 2 With HypoglycemiaNCT05461716
Incidence of Hypoglycaemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring
An observational study of Diabetes Mellitus Type 2 With Hypoglycemia, run by George E. Dafoulas at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2 With Hypoglycemia
- What is being tested?
- periodic use of Continuous Glucose Monitoring (CGM)
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the Primary Care Services or the Outpatient Department of the Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Alexandra Bargiota contact
Greece1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Metabolic Diseases, University Hospital of Larisa
Larissa, Thessaly, 41110
George E. Dafoulas, +306957830903, gdafoulas@med.uth.gr
Alexandra Bargiota, abargio@med.uth.gr
About this study
Official title: 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).
Read the 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).
- Being tested
- periodic use of Continuous Glucose Monitoring (CGM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of hypoglycaemic events
Measured: 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
Measured: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Glycaemic control (Time in Range)
Measured: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
EQ5D (Generic HRQL)
Generic Health Related Quality of Life (HRQL)
Measured: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Problem Areas in Diabetes scale - PAID (Disease specific HRQL)
Measured: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Assess the risk of hypoglycemia with Hypoglycemia Patient Questionnaire
Measured: 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
Measured: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 With HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George E. Dafoulas
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Research and Technology Hellas, University of Ioannina
- Responsible party
- Sponsor-investigator, George E. Dafoulas, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461716
- Sponsor's protocol ID
- 857223-UC3GR
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The IPD are going to be shared within the provisions of the European Commission Grant Agreement and Consortium Agreement of the Study
Publications
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.
PubMed 26254702Seaquist 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.
PubMed 23589542
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hypoglycemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus: Continuous Glucose Monitoring vs. Self-Monitored Blood Glucose
- ClinicalTrials.gov ID
- NCT05461716
- Acronym / sponsor ID
- 857223-UC3GR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- George E. DafoulasUniversity, hospital or other
- Collaborators
- Centre for Research and Technology Hellas, University of Ioannina
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Primary Care Services or the Outpatient Department of the Hospital
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | – |
Primary outcome
Detection of hypoglycaemic events
Time frame: frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
6 secondary outcomes
Glucose Management Indicator (GMI) correlation with HbA1c
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Glycaemic control (Time in Range)
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
EQ5D (Generic HRQL)
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Problem Areas in Diabetes scale - PAID (Disease specific HRQL)
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Assess the risk of hypoglycemia with Hypoglycemia Patient Questionnaire
Time frame: 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
Time frame: 12 weeks self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Background: PubMed 26254702Pazos-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.
- Background: PubMed 23589542Seaquist 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.
- Individual participant dataSharing planned: No. The IPD are going to be shared within the provisions of the European Commission Grant Agreement and Consortium Agreement of the Study
Related trials for Diabetes Mellitus Type 2 With Hypoglycemia
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Recruiting
Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App
Diabetes (DM), Diabetes Mellitus
Not yet recruitingPhase 1/2
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
Diabete Mellitus, Diabete Type 1
RecruitingPhase 2
A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus
Type II Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Bargiota contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 With Hypoglycemia, run by George E. Dafoulas at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George E, Dafoulas (+306957830903, gdafoulas@med.uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of hypoglycaemic events (time frame: frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.