NCT00760526

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 4, 2013

Completed
Last Updated

October 19, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

September 25, 2008

Results QC Date

October 26, 2012

Last Update Submit

September 2, 2016

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous Glucose Monitor

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events

    26 weeks

Secondary Outcomes (10)

  • Number of Severe Hypoglycemic Events Experienced by Participants

    26 weeks

  • CGM Glucose Values (mg/dL)

    26 weeks

  • Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)

    26 weeks

  • Measures of Variability: Standard Deviation (SD)

    26 weeks

  • Measures of Variability: Mean Absolute Rate of Change

    26 weeks

  • +5 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

continuous glucose monitoring

Device: Continuous glucose monitor

2

ACTIVE COMPARATOR

Standard glucose monitoring with a home glucose meter

Device: Home blood glucose monitor

Interventions

Continuous glucose monitorDEVICE

Daily use of a continuous glucose monitor

Also known as: FreeStyle Navigator, Medtronic Paradigm System
1
Home blood glucose monitorDEVICE

Home monitoring 3 or more times a day

Also known as: FreeStyle meter
2

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
  • Age \>4.0 to \<10.0 years
  • HbA1c \>= 7.0%
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Yale University, School of Medicine

New Haven, Connecticut, 06520, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Children's Hospital of Iowa, Department of Pediatrics

Iowa City, Iowa, 52242, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • Mauras N, Beck R, Xing D, Ruedy K, Buckingham B, Tansey M, White NH, Weinzimer SA, Tamborlane W, Kollman C; Diabetes Research in Children Network (DirecNet) Study Group. 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 aged 4 to <10 years. Diabetes Care. 2012 Feb;35(2):204-10. doi: 10.2337/dc11-1746. Epub 2011 Dec 30.

    PMID: 22210571RESULT

  • Triolo TM, Maahs DM, Pyle L, Slover R, Buckingham B, Cheng P, DiMeglio LA, Bremer AA, Weinzimer SA, Chase HP; Diabetes Research in Children Network (DirecNet) and Type 1 Diabetes TrialNet Study Groups. Effects of Frequency of Sensor-Augmented Pump Use on HbA1c and C-Peptide Levels in the First Year of Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):e61-2. doi: 10.2337/dc15-2201. Epub 2016 Feb 19. No abstract available.

    PMID: 26895885DERIVED

  • Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.

    PMID: 24130350DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Katrina Ruedy
Organization
Jaeb Center for Health Research
direcnet@jaeb.org
813-975-8690

Study Officials

  • Roy W Beck, MD, PhD

    Jaeb Center for Health Research

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

January 1, 2012

Last Updated

October 19, 2016

Results First Posted

December 4, 2013

Record last verified: 2016-09

Locations

US(5)