zimbie45
12-27-2006, 07:57 AM
Kids aged 8 and older are needed for a nation-wide Randomized Study
of Real-Time Continuous Glucose Monitors in the Management of Type 1
Diabetes.
http://www.clinicaltrial.gov/ct/show/NCT00406133
( {{{{ click link above to read full details...********)
Home Search Listings Resources Help What's New About
Randomized Study of Real-Time Continuous Glucose Monitors in the Management of Type 1 Diabetes
This study is currently recruiting patients.
Verified by JDRF Artificial Pancreas Project December 2006
Sponsored by: JDRF Artificial Pancreas Project
Information provided by: JDRF Artificial Pancreas Project
ClinicalTrials.gov Identifier: NCT00406133
Purpose
Subjects will be enrolled into the study which consists of two phases:
A 6-month randomized trial comparing a real-time continuous glucose monitor (RT-CGM) group with a control group that will use home glucose meter (HGM) monitoring and have the same number of scheduled phone contacts and visits as the RT-CGM group, followed by:
A 6-month observational study during which the RT-CGM Group continues to use RT-CGM to evaluate whether any beneficial effect seen in the first 6 months is sustained with longer-term use and less intensive contact and the control group initiates RT-CGM use with less intensive contact after the first month than was provided at initiation of RT-CGM use in the RT-CGM group in phase 1.
Condition Intervention Phase
Type 1 Diabetes
Device: FreeStyle Navigator
Device: DexCom STS
Device: Paradigm or Guardian REAL-Time
Phase II
Phase III
MedlinePlus related topics: Diabetes Type 1
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes
...................
Ages Eligible for Study: 8 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
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
HbA1c less than or equal to 10.0%
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)
Exclusion Criteria:
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00406133
Katrina J Ruedy, MSPH 813-975-8690 kruedy@jaeb.org
Judy Jackson 813-975-8690 jjackson@jaeb.org
California
Stanford University, Stanford, California, 94305, United States; Recruiting
Kimberly Caswell, APRN 650-724-1201 kcaswell@stanford.edu
Paula Clinton, RD, CDE (650) 736-2313 pclinton@stanford.edu
Bruce Buckingham, MD, Principal Investigator
Darrell Wilson, MD, Sub-Investigator
Kaiser Permanente, San Diego, California, 92111, United States; Recruiting
Michelle Maeva, RN 858-573-5440 Michelle.L.Maeva@kp.org
Robert Clemons, MD, Principal Investigator
Jean Lawrence, ScD MPH MSSA, Sub-Investigator
University of Southern California, Beverly Hills, California, 90211, United States; Not yet recruiting
Lucy Montoya 323-780-2333 lmontoya@chla.usc.edu
Sara Serafin-Dokhan (323) 780-2459 serafind@usc.edu
Anne Peters, MD, Principal Investigator
Ruchi Mathur, MD, Sub-Investigator
Kathryn M. Graves, MPH, RD, CDE, Sub-Investigator
Colorado
University of Colorado, Aurora, Colorado, 80010, United States; Recruiting
Laurel Messer, RN (303) 724-6742 Laurel.Messer@UCHSC.edu
Victoria Gage, RN (303) 724-6766 Victoria.Gage@UCHSC.edu
Peter Chase, MD, Principal Investigator
Rosanna Fiallo-Scharer, MD, Sub-Investigator
R. Paul Wadwa, MD, Sub-Investigator
Connecticut
Yale University School of Medicine, New Haven, Connecticut, 06520, United States; Recruiting
Brett Ives, ARNP 203-764-6650 brett.ives@yale.edu
Amy Steffen (203) 764-8451 amy.steffen@yale.edu
Stuart Weinzimer, MD, Principal Investigator
William Tamborlane, MD, Sub-Investigator
Florida
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States; Recruiting
Kimberly Englert, RN (904) 858-3056 Kenglert@nemours.org
Joe Permuy, RN, MSN (904) 858-3122 jpermuy@nemours.org
Tim Wysocki, PhD, ABPP, Principal Investigator
Nelly Mauras, MD, Sub-Investigator
Larry Fox, MD, Sub-Investigator
J. Atilio Canas, MD, Sub-Investigator
Priscilla Gagliardi, MD, Sub-Investigator
Robert Olney, MD, Sub-Investigator
Iowa
Children's Hospital of Iowa, Iowa City, Iowa, 52242, United States; Recruiting
Julie Coffey, MSN, ARNP 319-353-6070 julie-coffey@uiowa.edu
Joanne Cabbage (319) 353-6070 joanne-cabbage@uiowa.edu
Eva Tsalikian, MD, Principal Investigator
Michael Tansey, MD, Sub-Investigator
Massachusetts
Joslin Diabetes Center - Children, Boston, Massachusetts, 02215, United States; Recruiting
Kerry Milaszewski, RN, CDE 617-732-2603 Kerry.Milaszewski@joslin.harvard.edu
Margie Lawlor, MS, CDE (617) 732-2603 Margie.Lawlor@joslin.harvard.edu
Lori Laffel, MD, Principal Investigator
Jamie Redgrave, MD, Sub-Investigator
Korey Hood, PhD, Sub-Investigator
Joslin Diabetes Center - Adults, Boston, Massachusetts, 02215, United States; Recruiting
Astrid Atakov-Castillo 617-264-2767 astrid.atakov-castillo@joslin.harvard.edu
Stacey O'Donnell (617) 732-2699 stacey.o'donnell@joslin.harvard.edu
Howard Wolpert, MD, Principal Investigator
Washington
University of Washington, Seattle, Washington, 98105, United States; Recruiting
Kathleen Fitzpatrick, RN, MN, CDE 206-598-4882 kfitzpat@u.washington.edu
Dori Khakpour dorik@u.washington.edu
Irl Hirsch, MD, Principal Investigator
Lisa Gilliam, MD, PhD, Sub-Investigator
Sayed Sadrzadeh, MD, Sub-Investigator
Study chairs or principal investigators
Roy W Beck, MD, PhD, Study Director, Jaeb Center for Health Research
Lori Laffel, MD, Study Chair, Joslin Diabetes Center
William Tamborlane, MD, Study Chair, Yale University
More Information
Study ID Numbers: 2006-2402
Last Updated: December 11, 2006
Record first received: November 30, 2006
ClinicalTrials.gov Identifier: NCT00406133
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-12-26
of Real-Time Continuous Glucose Monitors in the Management of Type 1
Diabetes.
http://www.clinicaltrial.gov/ct/show/NCT00406133
( {{{{ click link above to read full details...********)
Home Search Listings Resources Help What's New About
Randomized Study of Real-Time Continuous Glucose Monitors in the Management of Type 1 Diabetes
This study is currently recruiting patients.
Verified by JDRF Artificial Pancreas Project December 2006
Sponsored by: JDRF Artificial Pancreas Project
Information provided by: JDRF Artificial Pancreas Project
ClinicalTrials.gov Identifier: NCT00406133
Purpose
Subjects will be enrolled into the study which consists of two phases:
A 6-month randomized trial comparing a real-time continuous glucose monitor (RT-CGM) group with a control group that will use home glucose meter (HGM) monitoring and have the same number of scheduled phone contacts and visits as the RT-CGM group, followed by:
A 6-month observational study during which the RT-CGM Group continues to use RT-CGM to evaluate whether any beneficial effect seen in the first 6 months is sustained with longer-term use and less intensive contact and the control group initiates RT-CGM use with less intensive contact after the first month than was provided at initiation of RT-CGM use in the RT-CGM group in phase 1.
Condition Intervention Phase
Type 1 Diabetes
Device: FreeStyle Navigator
Device: DexCom STS
Device: Paradigm or Guardian REAL-Time
Phase II
Phase III
MedlinePlus related topics: Diabetes Type 1
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Randomized Clinical Trial to Assess the Efficacy of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes
...................
Ages Eligible for Study: 8 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
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
HbA1c less than or equal to 10.0%
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)
Exclusion Criteria:
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00406133
Katrina J Ruedy, MSPH 813-975-8690 kruedy@jaeb.org
Judy Jackson 813-975-8690 jjackson@jaeb.org
California
Stanford University, Stanford, California, 94305, United States; Recruiting
Kimberly Caswell, APRN 650-724-1201 kcaswell@stanford.edu
Paula Clinton, RD, CDE (650) 736-2313 pclinton@stanford.edu
Bruce Buckingham, MD, Principal Investigator
Darrell Wilson, MD, Sub-Investigator
Kaiser Permanente, San Diego, California, 92111, United States; Recruiting
Michelle Maeva, RN 858-573-5440 Michelle.L.Maeva@kp.org
Robert Clemons, MD, Principal Investigator
Jean Lawrence, ScD MPH MSSA, Sub-Investigator
University of Southern California, Beverly Hills, California, 90211, United States; Not yet recruiting
Lucy Montoya 323-780-2333 lmontoya@chla.usc.edu
Sara Serafin-Dokhan (323) 780-2459 serafind@usc.edu
Anne Peters, MD, Principal Investigator
Ruchi Mathur, MD, Sub-Investigator
Kathryn M. Graves, MPH, RD, CDE, Sub-Investigator
Colorado
University of Colorado, Aurora, Colorado, 80010, United States; Recruiting
Laurel Messer, RN (303) 724-6742 Laurel.Messer@UCHSC.edu
Victoria Gage, RN (303) 724-6766 Victoria.Gage@UCHSC.edu
Peter Chase, MD, Principal Investigator
Rosanna Fiallo-Scharer, MD, Sub-Investigator
R. Paul Wadwa, MD, Sub-Investigator
Connecticut
Yale University School of Medicine, New Haven, Connecticut, 06520, United States; Recruiting
Brett Ives, ARNP 203-764-6650 brett.ives@yale.edu
Amy Steffen (203) 764-8451 amy.steffen@yale.edu
Stuart Weinzimer, MD, Principal Investigator
William Tamborlane, MD, Sub-Investigator
Florida
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States; Recruiting
Kimberly Englert, RN (904) 858-3056 Kenglert@nemours.org
Joe Permuy, RN, MSN (904) 858-3122 jpermuy@nemours.org
Tim Wysocki, PhD, ABPP, Principal Investigator
Nelly Mauras, MD, Sub-Investigator
Larry Fox, MD, Sub-Investigator
J. Atilio Canas, MD, Sub-Investigator
Priscilla Gagliardi, MD, Sub-Investigator
Robert Olney, MD, Sub-Investigator
Iowa
Children's Hospital of Iowa, Iowa City, Iowa, 52242, United States; Recruiting
Julie Coffey, MSN, ARNP 319-353-6070 julie-coffey@uiowa.edu
Joanne Cabbage (319) 353-6070 joanne-cabbage@uiowa.edu
Eva Tsalikian, MD, Principal Investigator
Michael Tansey, MD, Sub-Investigator
Massachusetts
Joslin Diabetes Center - Children, Boston, Massachusetts, 02215, United States; Recruiting
Kerry Milaszewski, RN, CDE 617-732-2603 Kerry.Milaszewski@joslin.harvard.edu
Margie Lawlor, MS, CDE (617) 732-2603 Margie.Lawlor@joslin.harvard.edu
Lori Laffel, MD, Principal Investigator
Jamie Redgrave, MD, Sub-Investigator
Korey Hood, PhD, Sub-Investigator
Joslin Diabetes Center - Adults, Boston, Massachusetts, 02215, United States; Recruiting
Astrid Atakov-Castillo 617-264-2767 astrid.atakov-castillo@joslin.harvard.edu
Stacey O'Donnell (617) 732-2699 stacey.o'donnell@joslin.harvard.edu
Howard Wolpert, MD, Principal Investigator
Washington
University of Washington, Seattle, Washington, 98105, United States; Recruiting
Kathleen Fitzpatrick, RN, MN, CDE 206-598-4882 kfitzpat@u.washington.edu
Dori Khakpour dorik@u.washington.edu
Irl Hirsch, MD, Principal Investigator
Lisa Gilliam, MD, PhD, Sub-Investigator
Sayed Sadrzadeh, MD, Sub-Investigator
Study chairs or principal investigators
Roy W Beck, MD, PhD, Study Director, Jaeb Center for Health Research
Lori Laffel, MD, Study Chair, Joslin Diabetes Center
William Tamborlane, MD, Study Chair, Yale University
More Information
Study ID Numbers: 2006-2402
Last Updated: December 11, 2006
Record first received: November 30, 2006
ClinicalTrials.gov Identifier: NCT00406133
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-12-26