Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT06311019 (Dia2tech) per Diabete di tipo 2 trattato con insulina è attivo, non in arruolamento. 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
The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections (Dia2tech) 104
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06311019 (Dia2tech) è uno studio interventistico per Diabete di tipo 2 trattato con insulina, attualmente attivo, non in arruolamento. Avviato il 27 febbraio 2024, prevede di arruolare 104 partecipanti. Sotto la guida di Klavs Würgler Hansen, dovrebbe concludersi entro il 1 settembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 7 novembre 2024.
Sommario breve
The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c >53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care.
Descrizione dettagliata
This study is a 12 months open-label randomized controlled trial.
Subjects with basal/bolus insulin treated T2DM and HbA1c >53 mmol/mol are randomized to:
A (control): standard care with disposable insulin pens and fingerprick glucose measurement or B (intervention): Novopen6 for bolus insulin and glucose measurement with Freestyle Libre 2.
Due to the nature of the treatments it is not possible to perform a blind...
Mostra di piùTitolo ufficiale
The Effects of Continuous Glucose Monitoring and Connected Insulin Pens on Glycemic Control in Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections.
Patologie
Diabete di tipo 2 trattato con insulinaAltri ID dello studio
- Dia2tech
- 791572
Numero NCT
Data di inizio (effettiva)
2024-02-27
Ultimo aggiornamento pubblicato
2024-11-07
Data di completamento (stimata)
2025-09-01
Arruolamento (previsto)
104
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Parole chiave
Type 2 diabetes mellitus
Insulin
Continuous glucose monitoring
Connected Pen
Insulin
Continuous glucose monitoring
Connected Pen
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Nessun intervento1 (Standard care) In this arm the patients continue to measure blood glucose with fingerprick and use standard insulin pens | N.D. |
Comparatore attivo2 (CGM and connected pen) In this arm the patients switch from glucose measurement with fingerprick to continuous glucose monitoring and they switch from standard insulin pen for bolusinsulin to connected pen for bolusinsulin | Continuous glucose monitoring and use of connected insulinpen for bolus insulin Continuous glucose monitoring (Abbott Freestyle Libre 2) and use of connected insulinpen (Novopen 6) for bolus insulin |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in Haemoglobin A1c | Change between groups in Haemoglobin A1c (mmol/mol) from baseline to follow-up
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change Time in range | Change in the fraction (%) of glucose values in the range 3.9 to 10.0 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Change in Time above range | Change in The fraction (%) of glucose values in the range \> 10.0 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Change in Time below range | Change in the fraction (%) of glucose values \< 3.9 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Mean glucose | The mean of all glucose values for 14 days measured by Libre Pro IQ.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Standard deviation | The standard deviation of glucose values for 14 days, measured by Libre Pro IQ.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Change in CV | Change in the coefficient of variation (%) for glucose values for 14 days, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Change in Time with rapid glucose change | Change in the time fraction (%) with glucose rate of change \> 1.5 mmol/l/15 min, measured by Libre Pro. A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
IQ for 14 days. | Baseline and follow-up after 12 months |
Change in ARRC | Change in Mean of average absolute change of glucose rate (ml/mol/15 min), measured by Libre Pro IQ for 14 days. A prespecified exploratory analysis is planned for:
male vs. female age \< 65 year vs. age ≥ 65 year baseline HbA1c \< 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for \> 2 meals Number of average views by Libre 2 for the last month \< 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days. | Baseline and follow-up after 12 months |
Fraction of patients with increased number of bolus insulin per day | The fraction of patients increasing from one or two meals with bolus insulin to two or three meals with bolus insulin. | Baseline and follow-up after 12 months |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- - Type 2 DM.
- - HbA1c > 53 mmol/l (7.0 %, estimated average glucose (eAG) 8.6 mmol/l).
- - Contact to diabetes clinic for ≥ 6 months.
- - Insulin treatment ≥ 12 months.
- - Basal insulin and bolus insulin at least for one meal every day.
- - Bolus insulin is insulin aspart.
- - Stable insulin treatment (change 10 % or less) and no introduction of other antihyperglycemic agents (oral or GLP1 analogue) for at least 2 months before randomization.
- - Considered to be technically and intellectually capable of using isCGM and smart pen.
- - Can communicate in Danish.
- - Informed consent including acceptance to share glucose data from the Libreview platforms.
- - The patient has a smart phone suitable for Libre and NOVOpen6 data registration.
- - Individual goal for HbA1c is reached (even if > 53 mmol/mol), i.e. relaxed treatment goals as relevant for fragile patients with severe diabetic complications or comorbidities.
- - Fasting C-peptide < 370 pmol/l.
- - Actual treatment with CGM or previous use of CGM for more than four weeks or < 6 months before recruitment. No actual or previous use of connected pen.
- - One or more severe hypoglycemic episode (assistance of third party) within the previous 12 months.
- - Considered unable to participate due to frequent cancellation of appointments.
- - Ongoing steroid treatment or expected intermittent treatment of more than 14 days' duration.
- - Pregnant or planning pregnancy.
- - Participating in other trials.
- - Clinical conditions interfering with interpretation of HbA1c (phlebectomy, bleeding or haemolytic disorders, erythropoietin treatment, known haemoglobin variants, etc.) or continuous intake of high dose of vitamin C (> 1000 mg), salicylic acid (650 mg daily), Salazopyrin or Dapsone.
- - Allergic reaction to the adhesive used in the isCGM.
Klavs Würgler HansenAarhus University HospitalParte responsabile dello studio
Klavs Würgler Hansen, Promotore-investigatore, Professor, Central Jutland Regional Hospital
Nessun dato di contatto
5 Centri dello studio in 1 paesi
Steno Diabetes Center Aarhus, Aarhus, 8000, Denmark
Gødstrup Regional Hospital, Herning, 7400, Denmark
Horsens Regional Hospital, Horsens, 8700, Denmark
Randers Regional Hospital, Randers, 8900, Denmark
Regional Hospital Silkeborg, Central Jutland Hospital, Silkeborg, 8600, Denmark