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Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM

2 settembre 2016 aggiornato da: Jaeb Center for Health Research

A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds)

The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

On the day of enrollment, a hemoglobin A1c level will be obtained, and potential subjects will be evaluated for study eligibility through the elicitation of a medical history and performance of a physical examination by a study investigator.

The subject will return for a second visit about 6 weeks after the enrollment visit. At this visit, quality of life questionnaires will be completed and a CGM sensor will be inserted. The monitor will be blinded so that the glucose values cannot be seen. The parent will be instructed on insertion, calibration, and care of the CGM.

The subject will return for a randomization visit 14 to 28 days after the blinded CGM was initiated.

  • Subjects who have been compliant with use of the CGM and HGM will be randomized to one of two treatment groups: CGM Group or Control Group
  • For the CGM Group, the CGM, HGM, and pump data (if applicable) will be reviewed and changes will be made to diabetes management as needed. Parents will be taught to use the protocol-developed instructions for changes to diabetes management to be used in real time based on CGM and HGM data. Instructions for downloading the CGM and HGM will be provided to subjects with a home computer.
  • For the Control Group, a HGM and test strips will be provided. The HGM and pump data (if applicable) will be reviewed and changes will be made in diabetes management as needed. The blinded CGM data will be downloaded but will not be reviewed by study personnel until the end of the first 6 months of the study. Parents will be taught to use the protocol-developed instructions for how to make changes to diabetes management based on HGM data.

Both groups will have follow-up visits at 1,4,8,13,19, and 26 weeks (+/- 1 week) plus one contact between each visit (including one phone contact between the second visit and the one week visit) to review their diabetes management.

  • Both groups will download device data on a weekly basis (if the subject has a computer). Subjects with email access will be instructed to email the downloaded data to the clinical center prior to each phone contact.
  • For both groups, at each visit, the HGM and pump (if applicable) will be downloaded and for the CGM group, the CGM will be downloaded.

In the 13th and 26th weeks, the Control Group will use a blinded CGM for one week. The CGM Group will continue to use the blinded CGM. The Control Group will return the blinded CGM to the clinic after a week. The data will be reviewed by personnel who are not involved in the care of the subject to determine if additional blinded sensor data are needed. The blinded data will not be reviewed by the study personnel for management decisions until the end of the first 6 months of the study.

Following the 26-week visit:

  • Subjects in the RT-CGM Group will continue to use the CGM.
  • Subjects in the Control Group will be provided with a CGM and sensors after the week of blinded use and will have visits after 1 week and 4 weeks, with a phone contact during the first and second weeks.
  • Both groups will have visits after 13 weeks and 26 weeks

Tipo di studio

Interventistico

Iscrizione (Effettivo)

146

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Stanford, California, Stati Uniti, 94305
        • Stanford University Medical Center
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
        • Yale University, School of Medicine
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32207
        • Nemours Children's Clinic
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • Children's Hospital of Iowa, Department of Pediatrics
    • Missouri
      • St. Louis, Missouri, Stati Uniti, 63110
        • Washington University School of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 4 anni a 9 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
  2. Age >4.0 to <10.0 years
  3. HbA1c >= 7.0%
  4. Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three 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)

Exclusion Criteria:

  1. Diabetes diagnosed <6 months of age
  2. 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.

  3. The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol:

    • Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
    • Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not exclude subjects from enrollment)
  4. Home use of CGM in past 6 months.
  5. Participation in an intervention study (including psychological studies) in past 6 weeks.
  6. Another member of the same household is participating in this study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 1
continuous glucose monitoring
Dispositivo: Monitoraggio continuo del glucosio
Uso quotidiano di un monitor continuo del glucosio
Altri nomi:
  • FreeStyle Navigator
  • Medtronic Paradigm System
Comparatore attivo: 2
Standard glucose monitoring with a home glucose meter
Dispositivo: Home blood glucose monitor
Home monitoring 3 or more times a day
Altri nomi:
  • FreeStyle meter

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events
Lasso di tempo: 26 weeks
26 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Severe Hypoglycemic Events Experienced by Participants
Lasso di tempo: 26 weeks
26 weeks
CGM Glucose Values (mg/dL)
Lasso di tempo: 26 weeks
Percentage of sensors values in range (71 mg/dL to 180 mg/dL)
26 weeks
Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)
Lasso di tempo: 26 weeks
CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.
26 weeks
Measures of Variability: Standard Deviation (SD)
Lasso di tempo: 26 weeks
standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.
26 weeks
Measures of Variability: Mean Absolute Rate of Change
Lasso di tempo: 26 weeks
mean absolute rate of change
26 weeks
Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)
Lasso di tempo: 26 weeks
Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55
26 weeks
Parental Quality of Life Measures: Hypoglycemia Fear Survey
Lasso di tempo: 26 weeks
The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0-100 with higher score denoting more fear. The results reported below are the values at 26 weeks.
26 weeks
Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)
Lasso di tempo: 26 weeks
The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.
26 weeks
Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale
Lasso di tempo: 26 weeks
The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1-4. Higher score denotes fewer problems in the past month.
26 weeks
Parental Quality of Life Measures: CGM Satisfaction Scale
Lasso di tempo: 26 weeks

Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)

JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679-684
26 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Jaeb Center for Health Research

Collaboratori

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigatori

  • Cattedra di studio: Roy W Beck, MD, PhD, Jaeb Center for Health Research

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2010

Completamento primario (Effettivo)

1 giugno 2011

Completamento dello studio (Effettivo)

1 gennaio 2012

Date di iscrizione allo studio

Primo inviato

25 settembre 2008

Primo inviato che soddisfa i criteri di controllo qualità

25 settembre 2008

Primo Inserito (Stima)

26 settembre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 ottobre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 settembre 2016

Ultimo verificato

1 settembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DirecNet 011
  • M01RR000069 (Sovvenzione/contratto NIH degli Stati Uniti)
  • HD041919-01,
  • HD041915-01,
  • HD041890,
  • HD041918-01,
  • HD041908-01,
  • HD041906-01,
  • RR00059,
  • RR 06022,
  • RR00070-41

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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