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De klinische studie NCT04630925 (INDIGO) voor Type 1 diabetes mellitus, Type 2 diabetes mellitus, Diabetes mellitus is beëindigd. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Universiteit van AarhusIn-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B 1
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De klinische studie NCT04630925 (INDIGO) is een interventioneel studie bij Type 1 diabetes mellitus, Type 2 diabetes mellitus, Diabetes mellitus met de status beëindigd. Het doel is om 1 deelnemers te includeren vanaf 4 januari 2021. De studie wordt geleid door de Universiteit van Aarhus en de voltooiing is gepland op 16 november 2022. Laatste update op ClinicalTrials.gov: 21 november 2022.
Beknopte samenvatting
The aim of the study is to investigate the applicability of a Flash glucose monitoring sensor (Freestyle Libre, isCGM) for in-hospital glucose monitoring in patients with diabetes and hypoglycemia (<3,9 mmol/l) during the hospitalization
Uitgebreide beschrijving
All patients who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by a trained clinical diabetes specialist and a trained study nurse (study personnel) for glucose management during their hospitalization. All patients included in the study will receive a Freestyle Libre isCGM. The patients will be randomized to control (blinded isCGM glucose values t...Toon meer
Officiële titel
In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B
Aandoeningen
Type 1 diabetes mellitusType 2 diabetes mellitusDiabetes mellitusAndere studie-ID's
- INDIGO
- 1-10-72-188-20, B
NCT-ID
Startdatum (Werkelijk)
2021-01-04
Laatste update geplaatst
2022-11-21
Verwachte einddatum
2022-11-16
Inschrijving (Geschat)
1
Studietype
Interventioneel
FASE
N.v.t.
Status
Beëindigd
Trefwoorden
Hypoglycemia
Continuous glucose monitoring
Hospitalization
Continuous glucose monitoring
Hospitalization
Primaire doel
Overige
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Actieve comparatorisCGM-arm CGM data will be viewed real-time and used to adjust diabetes treatment | isCGM As previously described |
Geen interventiePOC-arm POC glucose readings are used to adjust diabetes treatment. CGM data are blinded to all and only gathered for comparison purposes to intervention group. | N.v.t. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Glucose time in range (3,9-10 mmol/l) (% pr day) | Glucose time in range (3,9-10 mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) (% pr day) | 2-14 days |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Mean glucose (mmol/l) isCGM versus POC PG | Mean glucose (mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
Glycemic variability; coefficient of variation (CV) and standard deviation (SD) | CV and SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
Number and duration of events with hypoglycemia (<3 mmol/L and <3,9 mmol/l) (time in hypoglycemia) | Number and duration of events with hypoglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
Time in hyperglycemia (>10 mmol/l) | Time in hyperglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) undetected with POC PG (use of data from blinded CGM in control group) | 2-14 days | |
Daily total insulin dosage (IE) | Daily total insulin dosage (IE) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
Time with active isCGM | Time with active isCGM (%) in intervention group | 2-14 days |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Expected length of hospital stay of at least 48 hours
- Diagnosed with diabetes
- Literate in Danish
- In-hospital hypoglycemia with at least one POC glucose < 3,9 mmol/l (current hospitalization)
- In-hospital treatment with insulin or sulfonylurea
- Admission to Department of Gastrointestinal Surgery or Department of Heart-, Lung-, and Vascular surgery, both at Aarhus University Hospital, Denmark.
- Pregnancy
- Patient unable to provide informed consent
- Patient unable to use mobile phone for reading isCGM sensor
- Known allergy to adhesives
- Anticipated MRI during the hospital admission
- Patients using CGM prior to hospital admission
Universiteit van Aarhus305 actieve klinische studies om te verkennenAarhus University HospitalVerantwoordelijke instantie
Julie Støy, Hoofdonderzoeker, Clinical diabetes specialist, University of Aarhus
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Aarhus university hospital, Aarhus, 8200, Denmark