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De klinische studie NCT05461716 voor Diabetes Mellitus Type 2 With Hypoglycemia is onbekend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Incidence of Hypoglycaemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus Based on Continuous Glucose Monitoring 75
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De klinische studie NCT05461716 is een observationeel studie bij Diabetes Mellitus Type 2 With Hypoglycemia met de status onbekend. Het doel is om 75 deelnemers te includeren vanaf 1 januari 2022. De studie wordt geleid door George E. Dafoulas en de voltooiing is gepland op 31 maart 2023. Laatste update op ClinicalTrials.gov: 18 juli 2022.
Beknopte samenvatting
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 ...
Toon meerUitgebreide beschrijving
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 publis...
Toon meerOfficiële titel
Incidence of Hypoglycemia Events in Patients With Stable Insulin-treated Type 2 Diabetes Mellitus: Continuous Glucose Monitoring vs. Self-Monitored Blood Glucose
Aandoeningen
Diabetes Mellitus Type 2 With HypoglycemiaPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- 857223-UC3GR
NCT-ID
Startdatum (Werkelijk)
2022-01-01
Laatste update geplaatst
2022-07-18
Verwachte einddatum
2023-03-31
Inschrijving (Geschat)
75
Studietype
Observationeel
Status
Onbekend
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
N.v.t. | 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 |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Detection of hypoglycaemic events | frequency of hypoglycemia using the 12-week self-monitored blood glucose (SMBG) measurement profile and the 2 CGM weeks |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
40 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
- 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
George E. Dafoulas- Centre for Research and Technology Hellas
- University of Ioannina
Verantwoordelijke instantie
George E. Dafoulas, Sponsor-Onderzoeker, Clinical Research Fellow, University of Thessaly
Centraal Contactpersoon
Contact: George E, Dafoulas, +306957830903, [email protected]
Contact: Alexandra Bargiota, [email protected]
1 Studielocaties in 1 landen
Thessaly
Department of Endocrinology and Metabolic Diseases, University Hospital of Larisa, Larissa, Thessaly, 41110, Greece
George E. Dafoulas, Contact, +306957830903, [email protected]
Alexandra Bargiota, Contact, [email protected]
Rekruterend