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Die klinische Studie NCT03815006 (FLASH-UK) für Diabetes mellitus Typ 1 ist abgeschlossen. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
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Kartenansicht
Flash-glucose Monitoring in Sub-optimally Controlled Type 1 Diabetes (FLASH-UK) 156 Jugendliche Offene Studie Neuartig
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT03815006 (FLASH-UK) untersuchte Diabetes mellitus Typ 1 als interventionsstudie und hat den Status abgeschlossen. Die Studie begann am 9. Januar 2020 mit 156 Teilnehmern. Sie wurde durchgeführt von Manchester University NHS Foundation Trust und am 10. Oktober 2021 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 16. Oktober 2023 aktualisiert.
Kurzbeschreibung
FreeStyle Libre (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days, and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes. The purpose of this study is to determine whether flash glucose monitoring with FSL2 device will i...Mehr anzeigen
Ausführliche Beschreibung
Study Design:
An open-label, multi-centre, randomised, parallel study, in adults and adolescents (16 years and older) with type 1 diabetes and sub-optimal glycaemic control (HbA1c 7.5% to 11%), either on insulin pump treatment or multiple daily injections, contrasting flash glucose monitoring using FreeStyle Libre 2 device with traditional finger-stick glucose monitoring for 24 weeks. Expecting approximately 15% to ...
Mehr anzeigenOffizieller Titel
An Open-label, Multi-centre, Randomised, Parallel Design Study to Assess the Efficacy of Flash Glucose Monitoring in Adults With Sub-optimally Controlled Type 1 Diabetes.
Erkrankungen
Diabetes mellitus Typ 1Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- FLASH-UK
- B00373
NCT-Nummer
Studienbeginn (tatsächlich)
2020-01-09
Zuletzt aktualisiert
2023-10-16
Studienende (vorauss.)
2021-10-10
Geplante Rekrutierung
156
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Abgeschlossen
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellFree Style Libre 2 device At the start, a blood sample will be taken for the measurement of HbA1c. Training and education on the use of FSL2 will be provided by the research team. Participants will be advised to use flash glucose monitoring continuously for the next 24 weeks. | Free Style Libre 2 FreeStyle Libre 2 (FSL2) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D). |
Keine InterventionSelf-monitoring of blood glucose At the start, a blood sample will be taken for the measurement of HbA1c. Masked FSL will be applied for two weeks, during the last two weeks of control period. Education will focus on using fingerstick measurement for treatment optimisation. | Nicht zutreffend |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
HbA1c Level at 24 Weeks | The primary outcome is difference in HbA1c between the two groups at 24 weeks. | 24 weeks |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
HbA1c Level at 12 Weeks | This is the difference in HbA1c between the two groups at 12 weeks | 12 weeks |
Percentage With HbA1c ≤ 53 mmol/Mol (7.0%) at 12 Weeks | This is the comparison between arms of percentage with HbA1c ≤ 53 mmol/mol (7.0%) at 12 weeks | 12 weeks |
Percentage With HbA1c ≤ 53 mmol/Mol (7.0%) at 24 Weeks | This is the comparison between arms of percentage with HbA1c ≤ 53 mmol/mol (7.0%) at 24 weeks | 24 weeks |
Sensor Based - Time Spent in the Target Glucose Range Between 3.9 to 10.0 mmol/l | Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180mg/dl). | 24 weeks |
Sensor Based - Time Spent Below Target Glucose (<3.9mmol/l) | Time spent below target glucose (\<3.9mmol/l) (\<70mg/dl) | 24 weeks |
Sensor Based - Time Spent Above Target Glucose (10.0 mmol/l) | Time spent above target glucose (10.0 mmol/l) (180 mg/dl) | 24 weeks |
Sensor Based - Average Glucose Levels | Average glucose levels | 24 weeks |
Sensor Based - Standard Deviation Glucose Levels | Standard deviation glucose levels | 24 weeks |
Sensor Based - Coefficient of Variation Glucose Levels | Coefficient of variation glucose levels | 24 weeks |
Sensor Based - Time With Sensor Glucose Levels < 3.5 mmol/l | The time with sensor glucose levels \< 3.5 mmol/l (63 mg/dl) | 24 weeks |
Sensor Based - Time With Sensor Glucose Levels < 3.5 mmol/l | The time with sensor glucose levels \< 3.0 (54mg/dl) | 24 weeks |
Sensor Based - Time With Sensor Glucose Levels < 2.8 mmol/l | The time with sensor glucose levels \< 2.8 mmol/l (50 mg/dl) | 24 weeks |
Sensor Based - Time With Sensor Glucose Levels in the Significant Hyperglycaemia | The time with sensor glucose levels in the significant hyperglycaemia (glucose levels \> 16.7 mmol/l) (300mg/dl) | 24 weeks |
Sensor Based - AUC of Glucose Below 3.0mmol/l | AUC of glucose below 3.0mmol/l (54mg/dl) | 24 weeks |
Total Daily Average Insulin Dose | Comparison between arms of Total daily average insulin dose | 24 weeks |
Daily Average Basal Insulin Dose | Comparison between arms of Daily average basal insulin dose | 24 weeks |
Daily Average Bolus Dose | Comparison between arms of Daily average bolus dose | 24 weeks |
Average Number of Boluses of Rapid Acting Insulin | Average number of boluses of rapid acting insulin per day | 24 weeks |
Number of Freestyle Libre Scans Per Day | Number of Freestyle Libre scans per day in the intervention arm only | 24 weeks |
Frequency of Severe Hypoglycaemic Episodes | Frequency of severe hypoglycaemic episodes as defined by American Diabetes Association | 24 weeks |
Frequency of Significant Ketosis Events | Frequency of significant ketosis events (plasma ketones \>3mmol/l) | 24 weeks |
Nature and Severity of Other Adverse Events | Nature and severity of other adverse events. | 24 weeks |
Type 1 Diabetes Distress Scale Score | Type 1 Diabetes Distress Scale score compared between arms | 24 weeks |
EQ-5D-5L Quality of Life Questionnaire Score | EQ-5D-5L Quality of Life questionnaire | 24 weeks |
Patient Health Questionnaire Score | Patient Health Questionnaire: score of 5-9 would be minimal symptoms. any score large than 20 would be categorised as severe major depression | 24 weeks |
Diabetes Fear of Injecting and Self-Testing Questionnaire Score | Diabetes fear of injecting and self-testing questionnaire: 15 questions, 6 for Fear of Self injecting, 9 for fear of self testing. | 24 weeks |
The Revised Diabetes Eating Problem Survey Score | The revised Diabetes Eating Problem Survey | 24 weeks |
Average Number of Days of Libre Usage Per Week | Average number of days of usage per week | 24 weeks |
Diabetes Treatment Satisfaction Questionnaire Score | Diabetes Treatment Satisfaction Questionnaire | 24 weeks |
Glucose Monitoring Satisfaction Survey Score | Glucose Monitoring Satisfaction Survey: 15 questions ranging from 1-5. | 24 weeks |
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene, Ältere Erwachsene
Mindestalter
16 Years
Zugelassene Geschlechter
Alle
- The participant is ≥16 years old
- The participant has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative if duration of diabetes is < 1 years
- Participant is treated with insulin pump or multiple daily injection for at least 12 weeks and no plans to change treatment modality during next 28 weeks
- The participant is literate in English for safe study conduct
- Screening HbA1c ≥ 7.5% (58.5mmol/mol) and ≤ 11% (97 mmol/mol) based on analysis from local laboratory
- The participant is willing to wear study glucose sensor and scan for glucose levels at regular intervals
- The participant is willing to follow study specific instructions and improve glucose control
- Female participants of child bearing age should be on effective contraception and must have a negative blood or urine pregnancy test at screening.
- The participant adopting a virtual pathway through the trial is able and willing to post study devices, questionnaires and blood collection kits back to the research team or to the laboratory using pre-paid postal services.
- The participant adopting a virtual pathway through the trial has internet connection, appropriate videoconferencing software and supporting devices to undertake video consultations where necessary.
Key exclusion criteria:
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical disease or people with known severe mental illness (psychotic disorder, bipolar disorder, dementia, substance and alcohol dependence, learning disabilities, depression with active suicidal ideation) which are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- Current users of real-time glucose monitoring sensors or flash-glucose monitoring for more than 4 weeks within last 12 weeks
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, SGLT2 inhibitors, GLP-1 agonists, Pramlinatide, non-selective beta-blockers and MAO inhibitors etc.(patients on stable metformin is not an exclusion)
- Known or suspected allergy against insulin
- Severe visual impairment
- Complete loss of hypoglycaemia awareness
- Significant renal impairment eGFR<30 within previous one year or on dialysis or active retinopathy (defined as presence of maculopathy or proliferative changes) as judged by the investigator
- More than one episode of severe hypoglycaemia as defined by American Diabetes Association (30) in preceding 24 weeks
Manchester University NHS Foundation TrustKeine Kontaktdaten vorhanden
8 Studienstandorte in 1 Ländern
Dorset
The Adam Practice, Poole, Dorset, BH16 5PW, United Kingdom
College of Medical and Dental Sciences University of Birmingham, Birmingham, B152TT, United Kingdom
Addenbrooke's Hospital, Cambridge, CB20QQ, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust, Derby, DE223NE, United Kingdom
Ipswich Hospital, Ipswich, IP4 5PD, United Kingdom
Manchester University NHS Foundation Trust, Manchester, M139WL, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, NR47UY, United Kingdom
Queen Alexandra Hospital, Portsmouth, PO63LY, United Kingdom