Trial Radar AI | ||
|---|---|---|
De klinische studie NCT03365180 voor Diabetes mellitus, type 2 is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Starter Kit Study in Insulin naïve Patients Fase 2, Fase 3 8
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT03365180 onderzocht behandeling bij Diabetes mellitus, type 2. Deze Fase 2 Fase 3 interventioneel studie is nu afgerond. Er werd gestreefd naar inclusie van 8 deelnemers vanaf 3 januari 2018. De studie werd geleid door Signe Schmidt en was gepland te worden voltooid op 15 januari 2020. Laatste update op ClinicalTrials.gov: 12 februari 2020.
Beknopte samenvatting
The concept consists of an initial period (two weeks) of intensive data capture by use of continuous glucose monitoring (CGM) during basal insulin initiation, followed by a second period (variable duration) of basal insulin titration guided by self monitored blood glucose. Data captured during the first period are used as input to an algorithm that estimates the optimal daily dose for the individual patient. The esti...Toon meer
Officiële titel
Starter Kit Study in Insulin naïve Patients With Type 2 Diabetes
Aandoeningen
Diabetes mellitus, type 2Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- StarterKit2017
NCT-ID
Startdatum (Werkelijk)
2018-01-03
Laatste update geplaatst
2020-02-12
Verwachte einddatum
2020-01-15
Inschrijving (Geschat)
8
Studietype
Interventioneel
FASE
Fase 2
Fase 3
Fase 3
Status
Afgerond
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelThe Starter Kit Algorithm Basal insulin initiation and titration using the Starter Kit Algorithm at two weeks, followed by standard of care titration during the following the next 10 weeks (maximum), or until optimal daily dose is considered identified. | Starter Kit Algorithm Long acting insulin titration to target |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Accuracy of estimate 1 | Accuracy of the estimated optimal daily dose (calculated by the Starter Kit algorithm based on continuous glucose monitoring (CGM) data collected during day 1-14) compared with the observed optimal daily dose in percentage deviation.
In this context, optimal daily dose is the dose considered to keep fasting glucose levels below 6 mmol/L. | through study completion, 12 weeks |
Accuracy of estimate 2 | The number of estimated optimal daily doses by the Starter Kit Algorithm at two weeks that fall within a patient specific confidence interval.
The confidence interval is determined using the Starter Kit Algorithm at the end of study, one interval for each patient.
Upper boundary: the optimal daily dose estimated to bring lowest hour of CGM values within a day to 4.0 mmol/L Lower boundary: the optimal daily dose estimated to bring lowest hour of CGM values within a day to 6.0 mmol/L | through study completion, 12 weeks |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Accuracy of estimate 3 | Accuracy of the estimated optimal daily dose (calculated based on self-monitored blood glucose data collected during day 1-14) compared with the observed optimal daily dose. | through study completion, 12 weeks |
Number of patients in glucose target | Number of participants in target at end of study | through study completion, 12 weeks |
Algorithm deviations | Number of titration algorithm deviations due to risk of hypoglycemia (based on evaluation of CGM data) | 12 weeks (total duration of study) |
Quality of treatment 1 | Qualitative assessment by the investigator of participants who do not reach the observed optimal daily dose within 12 weeks: Frequency of participants who are in need of additional basal insulin to achieve the target blood glucose. | through study completion, 12 weeks |
Quality of treatment 2 | Qualitative assessment by the investigator of participants who do not reach the observed optimal daily dose within 12 weeks: Frequency of participants who are in need of additional drugs to achieve the target blood glucose. | through study completion, 12 weeks |
Number of self-monitored blood glucose values ≤3.9 mmol/L | Number of self-monitored blood glucose values ≤3.9 mmol/L | 12 weeks (total duration of study) |
Number of self-monitored blood glucose values ≤3.0 mmol/L | Number of self-monitored blood glucose values ≤3.0 mmol/L | 12 weeks (total duration of study) |
Severe hypoglycemia | Number of severe hypoglycemic events (defined as severe cognitive impairment requiring external assistance for recovery). | 12 weeks (total duration of study) |
Time spent in hypoglycemia | Time spent in hypoglycemia (\<3.9 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose). | 8 days (first four and last four days of study) |
Time spent in hyperglycemia | Time spent in hyperglycemia (\>10 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose). | 8 days (first four and last four days of study) |
Time spent in normoglycemia | Time spent in normoglycemia (3.9-10.0 mmol/L) assessed by CGM during the first four study days (days without insulin) and the last four study days (days with optimal daily insulin dose). | 8 days (first four and last four days of study) |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Type 2 diabetes
- Age 18-75 years
- HbA1c 53-86 mmol/mol (7.0-10.0%)
- BMI 20-40 kg/m2
- Insulin-naïve
- Willingness to use CGM consistently during the study period and send/receive data and dose advice to/from HCP via a mobile phone
- Signed informed consent prior to any study procedures
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Active proliferative retinopathy
- Mean blood glucose > 15 mmol/l the week prior to screening
- Blood glucose > 20 mmol/l on the screening day
- Non-fasting ketones > 0,5 mmol/l on the screening day
- Use of sulfonylurea within 14 days prior to or during the study period
- Change in other antidiabetic medicine than basal insulin during the study period
- Use of corticosteroids within 30 days prior to or during the study period
- Marked change in lifestyle within 30 days prior to or during the study period as assessed by the investigator
- People with type 2 diabetes that suffer from conditions which make tight diabetes control undesirable, e.g. severe cardiovascular disease, according to the investigator
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- Overall treatment
Signe Schmidt- Technical University of Denmark
- Novo Nordisk131 actieve klinische studies om te verkennen
Verantwoordelijke instantie
Signe Schmidt, Sponsor-Onderzoeker, Principal Investigator, Hvidovre University Hospital
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Hvidovre University Hospital, Hvidovre, 2650, Denmark