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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Collaborator: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00760526 |
Purpose
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 8 years of age with type 1 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 |
Device: Continuous glucose monitor |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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) |
| Estimated Enrollment: | 140 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Use of continuous glucose monitor for 12 months
|
Device: Continuous glucose monitor
Daily use of a continuous glucose monitor
|
|
2: No Intervention
Standard glucose monitoring with a home glucose meter for 6 months, then use of a continuous glucose monitor for the second 6 months
|
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.
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.
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:
Eligibility| Ages Eligible for Study: | 4 Years to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol:
Contacts and Locations| Contact: Katrina J Ruedy, MSPH | (813) 975-8690 | direcnet@jaeb.org |
| Contact: Judy Jackson | (813) 975-8690 |
| United States, California | |
| Stanford University Medical Center | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Kimberly Caswell, APRN BC 650-724-1201 kcaswell@stanford.edu | |
| Contact: Kari Benassi, RN, NP (650) 736-8948 karis@stanford.edu | |
| Principal Investigator: Bruce Buckingham, MD | |
| Sub-Investigator: Darrell Wilson, MD | |
| United States, Connecticut | |
| Yale University, School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Brett Ives, ARNP 203-764-6650 brett.ives@yale.edu | |
| Contact: Lori Carria (203) 737-3595 Lori.carria@yale.edu | |
| Principal Investigator: Stuart Weinzimer, MD | |
| Sub-Investigator: William Tamborlane, MD | |
| United States, Florida | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Kim Englert, BSN, RN 904-858-3056 Kenglert@nemours.org | |
| Principal Investigator: Nelly Mauras, MD | |
| Sub-Investigator: Larry Fox, MD | |
| United States, Iowa | |
| Children's Hospital of Iowa, Department of Pediatrics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Julie Coffey, MSN, ARNP 319-353-6070 julie-coffey@uiowa.edu | |
| Principal Investigator: Eva Tsalikian, MD | |
| Sub-Investigator: Michael Tansey, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Lucy Levandoski, PA-C 314-286-1107 Levandoski_l@kids.wustl.edu | |
| Contact: Melanee Coleman, RN, MSN (314) 286-1107 Coleman_m@kids.wustl.edu | |
| Principal Investigator: Neil White, MD, CDE | |
| Sub-Investigator: Ana Maria Arbelaez, MD | |
| Study Chair: | Roy W Beck, MD, PhD | Jaeb Center for Health Research |
More Information
| Responsible Party: | Jaeb Center for Health Research ( Roy Beck, MD, PhD ) |
| Study ID Numbers: | DirecNet 011, HD041919-01,, HD041915-01,, HD041890,, HD041918-01,, HD041908-01,, HD041906-01,, M01 RR00069,, RR00059,, RR 06022,, RR00070-41 |
| Study First Received: | September 25, 2008 |
| Last Updated: | April 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00760526 History of Changes |
| Health Authority: | United States: Federal Government |
|
Continuous Glucose Monitor |
|
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |