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

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)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

HbA1c [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severe hypoglycemia [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Percentage of sensors values in range (71 mg/dL to 180 mg/dL) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Biochemical hypoglycemia (percentage of sensor values </= 70 mg/dL [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Measures of variability: mean amplitude of glycemic excursions (MAGE), SD, mean absolute rate of changes [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Parental quality of life measures [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	4 Years to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
Age >4.0 to <10.0 years
HbA1c > 7.5%
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:

Diabetes diagnosed <6 months of age
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 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)
Home use of CGM in past 6 months.
Participation in an intervention study (including psychological studies) in past 6 weeks.
Another member of the same household is participating in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760526

Contacts

Contact: Katrina J Ruedy, MSPH	(813) 975-8690	direcnet@jaeb.org
Contact: Judy Jackson	(813) 975-8690

Locations

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

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

Investigators

Study Chair:

Roy W Beck, MD, PhD

Jaeb Center for Health Research

More Information

No publications provided

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

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Continuous Glucose Monitor

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 05, 2009