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Lo studio clinico NCT00406133 per Diabete 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. | ||
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Randomized Study of Real-Time Continuous Glucose Monitors (RT-CGM) in the Management of Type 1 Diabetes Fase III 451 Randomizzato
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La sperimentazione clinica NCT00406133 è stata uno studio interventistico di Fase III condotto per esaminare il trattamento per Diabete di tipo 1, attualmente completato. Avviato il 1 dicembre 2006, ha previsto l'arruolamento di 451 partecipanti. Sotto la guida di Jaeb Center for Health Research, si è concluso il 1 febbraio 2009. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 14 aprile 2017.
Sommario breve
Subjects with intensively-treated type 1 diabetes and glycated hemoglobin (HbA1c) 7.0%-10.0% in 3 age groups (>25, 15-24, 8-14) will be randomized to a continuous glucose monitoring (CGM) group or control group. The primary outcome is change in HbA1c after 26 weeks. A parallel randomized trial is being conducted for a second cohort with HbA1c <7.0% that will follow an identical protocol to that of the first cohort ...Mostra di più
Descrizione dettagliata
- On the day of enrollment, a glycated hemoglobin (HbA1c) level will be obtained, psychosocial questionnaires will be completed, and instructions will be given for use of the real time continuous glucose monitoring device (RT-CGM). The study personnel will supervise the subject or parent inserting the RT-CGM sensor in the clinic and will instruct the subject or parent to insert a second sensor at home as needed. To ...
Titolo ufficiale
A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) in the Management of Type 1 Diabetes
Patologie
Diabete di tipo 1Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- 2006-2402
Numero NCT
Data di inizio (effettiva)
2006-12
Ultimo aggiornamento pubblicato
2017-04-14
Data di completamento (stimata)
2009-02
Arruolamento (previsto)
451
Tipo di studio
Interventistico
FASE
Fase III
Stato
Completato
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Nessun interventoStandard intensive glucose monitoring Patients in the control group were given blood glucose meters and test strips and asked to perform home blood glucose monitoring at least four times daily. | N.D. |
Comparatore attivoContinuous Glucose Monitoring (CGM) Patients in the CGM group were instructed to use the CGM device on a daily basis and to verify the accuracy of the glucose measurement with a home blood glucose meter (provided by the study) before making management decisions (as per the regulatory labeling of the devices). | Monitoraggio continuo del glucosio Daily use of a continuous glucose monitor |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c >=7.0% Cohort) | The primary outcome was the Change in glycated hemoglobin (HbA1c) from baseline to 26 weeks, as determined by a central laboratory (for the cohort with baseline HbA1c \>=7.0% cohort). | Baseline and 26 weeks |
Time With Glucose Level <=70 mg/dL (for the Cohort With Baseline HbA1c <7.0%) | The primary outcome was the change in the time per day with glucose values \<=70mg/dL comparing baseline sensor values with those obtained following the 26-week visit. | Baseline and 26 weeks |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Severe Hypoglycemia (for the Cohort With Baseline HbA1c >=7.0% Cohort) | Measure of the number of severe hypoglycemic events in the cohort with baseline HbA1c \>=7.0% cohort | Baseline and 26 weeks |
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range. | Baseline and 26 weeks |
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort) | Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range. | Baseline and 26 weeks |
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c >=7.0% Cohort | Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range. | Baseline and 26 weeks |
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=70 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL) | Baseline and 26 weeks |
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c >=7.0%) | Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=50 mg/dL) | Baseline and 26 weeks |
Glucose (mg/dl) at Baseline and 26 Weeks (for Cohort With Baseline HbA1c >=7.0%) | Glucose variability was assessed by computing the absolute rate of change. | Baseline and 26 weeks |
Change in Glycated Hemoglobin (HbA1c) From Baseline to 26 Weeks in the Continuous Glucose Monitoring (CGM) and Control Groups (for the Cohort With Baseline HbA1c <7.0% Cohort) | The secondary outcome was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks in the Continuous Glucose Monitoring (CGM) and Control groups (for the cohort with baseline HbA1c \<7.0% cohort), as determined by a central laboratory. | Baseline and 26 weeks |
Minutes Per Day of Continuous Glucose Monitoring (CGM) Glucose Values 71-180 mg/dL (for Cohort With Baseline HbA1c <7.0%) | Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range. | Baseline and 26 weeks |
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >180 mg/dL (for Cohort With Baseline HbA1c <7.0%) | Data regarding CGM were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range. | Baseline and 26 weeks |
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values >250 mg/dL (for the Cohort With Baseline HbA1c <7.0% Cohort | Data regarding continuous glucose monitoring were obtained after completion of the 26-week visit with the use of an unblinded device in the RT-CGM group and a blinded device in the Control group. Measure consists of minutes/day in range. | Baseline and 26 weeks |
Minutes Per Day Continuous Glucose Monitoring (CGM) Glucose Values <=50 mg/dL (for Cohort With Baseline HbA1c <7.0%) | Data regarding continuous glucose monitoring in both groups after the 26-week visit were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=50 mg/dL) | Baseline and 26 weeks |
Absolute Rate of Change (mg/dl/Min) at 26 Weeks (for Cohort With Baseline HbA1c <7.0%) | Glucose variability was assessed by computing the absolute rate of change. | Baseline and 26 weeks |
Quality of Life | Hypoglycemia Fear Survey Total Score Average score of all items giving equal weight to each item. Scale 0-100 with higher score denoting more fear or more likely to avoid low blood glucose. | 26 weeks |
Cost-effectiveness of CGM. | Estimated total costs divided by estimated Quality-Adjusted Life Weeks (QALW) calculated per group | 26 weeks |
QALW | Quality Adjusted Life Weeks: We collected experienced utility data by eliciting time tradeoff (TTO) utilities for overall experience. Patients were asked to consider their current state of health in comparison to life in perfect health. Experienced utilities were elicited at baseline, 13 weeks, and 26 weeks. For children aged \<18 years, parents served as surrogates. The total quality-adjusted life weeks (QALWs) were calculated as the area under the quality-of-life time trends under each arm. | 26 weeks |
Total Costs: Direct and Indirect Costs | Investigators reported time spent with patients on CGM training and diabetes management excluding research time. Adult patients (or caregivers of children) self-reported health service utilization including routine office visits, after-hours clinic visits, emergency room visits, 911 calls, and hospitalizations. The daily cost of CGM technology was calculated based on FDA recommended frequency of sensor replacement and the expected frequency of receiver and transmitter replacement. The costs of the three devices used during the trial were averaged to arrive at a daily cost of CGM of $13.85. This daily cost was multiplied by the reported weekly use of CGM to arrive at an overall cost of CGM technology. Indirect costs: self-reported number of hours devoted to diabetes care per day, number of days missed from work or school due to diabetes, and number of days of work underperformance. Unit costs available at: http://care.diabetesjournals.org/cgi/content/full/dc09-2042/DC1 (Table 1). | 26 weeks |
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
8 Years
Sessi idonei
Tutti
Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
Age >8 years
Glycated hemoglobin(HbA1c) 7.0%-10.0% for the primary cohort and <7.0% for the secondary cohort
- The DCA2000 or comparable point of care device will be used to assess eligibility.
Insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) and has been stable for the last two months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)
- Subjects using premixed fixed doses of insulin at the time of enrollment will not be eligible
Subject (and parent/guardian for children) understands the study protocol and agrees to comply with it
Subjects >9 years old and primary care giver (i.e., parent or guardian if subject is a minor) comprehend written English or Spanish
- This requirement is due to the fact that the questionnaires to be used as outcome measures do not have validated versions in other languages.
- Spanish-speaking subjects will be enrolled only if a RT-CGM device that functions in Spanish and has a User Guide in Spanish is available.
No expectation that subject will be moving out of the area of the clinical center during the next year, unless the move will be to an area served by another study center.
Informed Consent Form signed by the subject (or parent/guardian if subject is a minor, with subject signing the Child Assent Form)
The presence of a significant medical disorder or use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
The presence of any of the following diseases:
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
- Cystic fibrosis
Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
Inpatient psychiatric treatment in the past 6 months (if the subject is a minor, for either the subject or the subject's primary care giver).
Home use of RT-CGM in past 6 months
- Use of a CGMS or GlucoWatch does not exclude subjects from enrollment
Participation in an intervention study (including psychological studies) in past 6 weeks.
Another member of the same household is participating in this study.
For females, pregnant or intending to become pregnant during the next year Pregnancy is an exclusion because of uncertainty about the lag between interstitial fluid glucose and blood glucose during pregnancy, which might affect the accuracy of the sensor. Subjects who become pregnant during the study will be discontinued from the study.
Jaeb Center for Health ResearchJDRF Artificial Pancreas ProjectNessun dato di contatto
11 Centri dello studio in 1 paesi
California
University of Southern California, Beverly Hills, California, 90211, United States
Kaiser Permanente, San Diego, California, 92111, United States
Stanford University, Stanford, California, 94305, United States
Colorado
University of Colorado, Aurora, Colorado, 80010, United States
Connecticut
Yale University School of Medicine, New Haven, Connecticut, 06520, United States
Florida
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States
Iowa
Children's Hospital of Iowa, Iowa City, Iowa, 52242, United States
Massachusetts
Joslin Diabetes Center - Adults, Boston, Massachusetts, 02215, United States
Joslin Diabetes Center - Children, Boston, Massachusetts, 02215, United States
Washington
University of Washington, Seattle, Washington, 98105, United States