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Lo studio clinico NCT03445377 (MILLENNIALS) per Diabete mellito di tipo 1 è completato. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS (MILLENNIALS) 32
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La sperimentazione clinica NCT03445377 (MILLENNIALS) è stata uno studio interventistico per Diabete mellito di tipo 1, attualmente completato. Avviato il 16 luglio 2018, prevedeva di arruolare 32 partecipanti. Sotto la guida di Manchester University NHS Foundation Trust, si è concluso il 28 giugno 2020. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 16 marzo 2021.
Sommario breve
The main objective of this study is to determine whether real-time continuous glucose monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (SMBG) in young adults with type 1 diabetes.
Descrizione dettagliata
This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order. Subjects will wear a blinded CGM for a 3-week period during the Control phase. A total of up to 40 subjects (aiming for 30 completed subjects) aged 16 ...Mostra di più
Titolo ufficiale
An Open-label, Single-centre, Randomised, Cross-over Design Feasibility Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Comparison With Self-monitoring of Blood Glucose in Young Adults and Adolescents With Type 1 Diabetes
Patologie
Diabete mellito di tipo 1Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- MILLENNIALS
- R04778
Numero NCT
Data di inizio (effettiva)
2018-07-16
Ultimo aggiornamento pubblicato
2021-03-16
Data di completamento (stimata)
2020-06-28
Arruolamento (previsto)
32
Tipo di studio
Interventistico
FASE
N.D.
Stato
Completato
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
Studio incrociato
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivoReal-time continuous glucose monitoring Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. Training on the use of DEXCOM G5 or similar will be provided by the research team. Competency on the use of the system will be evaluated. Participants will be advised to use real-time CGM continuously for the next 8 weeks. At the end of the first intervention, a blood sample for the measurement of HbA1c will be taken. Validated q...Mostra di più | Real-time continuous glucose monitoring Subjects randomised to Real-time continuous glucose monitoring will be given a Dexcom G5 or similar, training on its use, and HbA1c measurements taken at the start and end of the study. They will also be given validated questionnaires to complete. |
Comparatore placeboSelf-monitoring of blood glucose Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. During the Control Period, masked CGM will be applied for one week, during Week 1, 4 and 8. At the end of this, a blood sample for the measurement of HbA1c will be taken. Validated questionnaires evaluating diabetes-related distress, management and user acceptance will be completed. | Self-monitoring of blood glucose Subjects randomised to self monitoring of blood glucose will be given a masked CGM which will be applied for one week, during Week 1, 4 and 8. HbA1c measurements will be taken at the start and end of the study. They will also be given validated questionnaires to complete. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Sensor Glucose readings within target range | Time spent in the target range of 3.9 to 10mmol/l based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Sensor Glucose readings below target range | Time spent with glucose levels below 3.9 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks |
Sensor Glucose readings above target range | Time spent with glucose levels above 10.0 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks |
HbA1c at 8 weeks | HbA1c at 8 weeks (midway point) | 8 weeks |
Average variation of glucose levels | Average variation of glucose levels | 8 weeks |
Standard deviation variation of glucose levels | Standard deviation variation of glucose levels | 8 weeks |
Coefficient variation of glucose levels | Coefficient variation of glucose levels | 8 weeks |
The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l | The time with sensor glucose levels \< 3.5 mmol/l , 3.0 and \<2.8 mmol/l | 8 weeks |
The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) | The time with glucose levels in the significant hyperglycaemia (glucose levels \> 16.7 mmol/l) | 8 weeks |
AUC of glucose below 3.5mmol/l | AUC (Area under the Curve) of glucose below 3.5mmol/l | 8 weeks |
Total daily insulin dose | Total, basal and bolus insulin dose | 8 weeks |
Criteri di eleggibilità
Età idonea
Bambino, Adulto
Età minima
16 Years
Sessi idonei
Tutti
- Age between 16 - 24 years old (inclusive)
- Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment
- Treated with insulin pump or MDI
- Has a Smart phone compatible with Dexcom G5 or similar
- Willingness to wear study devices
- Willing to follow study specific instructions
- Literate in English
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study
- Untreated celiac disease or hypothyroidism
- Current or planned users of real-time or flash (Libre) glucose monitoring sensors
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers and MAO inhibitors etc.
- Regular use of acetaminophen
- Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
- Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor)
- Lack of reliable telephone facility for contact
- Known or suspected allergy against insulin
- Severe visual impairment
- Severe hearing impairment
- Subject not proficient in English
Manchester University NHS Foundation TrustDexCom, Inc.Nessun dato di contatto
1 Centri dello studio in 1 paesi
Manchester Diabetes Centre, Manchester University NHS Foundation Trust, Manchester, M13 9WL, United Kingdom