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Diabetes MellitusPhase 4NCT00069602

Assessing Continuous Glucose Monitors in Healthy Children

A Phase 4 study testing Continuous Glucose Monitoring System (CGMS) and GlucoWatch G2TM Biographer (GW2B) in people with Diabetes Mellitus, run by Jaeb Center for Health Research at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to… Read more about this study

Who is it for?
Ages 7 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
Continuous Glucose Monitoring System (CGMS) and GlucoWatch G2TM Biographer (GW2B)
Type of treatment
Medical device
How many people
20 participants
Where
6 sitesUnited States
Study dates
Aug 2002to Nov 2002
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Weight >= 16.0 kg (35 lbs)
  • Body mass index between the 10th to 90th percentile for age and sex
  • HbA1c within normal limits
  • Hematocrit within normal limits

Who cannot join

  • History of diabetes
  • History of positive islet cell antibody testing
  • Family history of Type 1 or Type 2 diabetes in a sibling or parent
  • Medication use of any type in the 7 days prior to study entry
  • Skin abnormalities contraindicating device use

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Barbara Davis Center for Childhood Diabetes, University of Colorado

    Denver, Colorado, 80262

  • Department of Pediatrics, University of Iowa Carver College of Medicine

    Iowa City, Iowa, 52242

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • Department of Pediatrics, Yale University School of Medicine

    New Haven, Connecticut, 06519

  • Division of Pediatric Endocrinology and Diabetes, Stanford University

    Stanford, California, 94305-5208

  • Jaeb Center for Health Research

    Tampa, Florida, 33647

Other trials in United States

About this study

Official title: DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children

Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose levels in children.

Read the detailed description

The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate.

The study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to 17 years old) who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families. Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations.

Being tested
Continuous Glucose Monitoring System (CGMS), GlucoWatch G2TM Biographer (GW2B)
Keywords
Continuous Glucose Monitoring Devices, Blood glucose profiles in normal children, Blood glucose profiles in non-diabetic children
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose Monitoring System (CGMS)Device

  • GlucoWatch G2TM Biographer (GW2B)Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of the GlucoWatch G2 Biographer and CGMS sensors

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2003 (estimated)
  2. Study startAug 2002
  3. Study completionNov 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069602
Sponsor's protocol ID
DirecNet 002
Other IDs
HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915
Status last verified
Sep 2016
First submitted
29 Sep 2003
Last updated
5 Sep 2016
Results posted
No

Publications

  • Mauras N, Beck R, Ruedy K, Booth A, Weinzimer S, and the Diabetes Research in Children Network (DirecNet) Study Group. The Physiological Variations of Plasma Glucose Concentrations in Healthy, Non-Diabetic Children: Use of Continuous Glucose Sensors. Pediatr Res 2003 Apr;53(4Pt 2):1A-669A

  • Weinzimer S, Beck R, Ruedy K, Booth A, Boland E, and the Diabetes Research in Children Network (DirecNet) Study Group. Mealtime Glycemic Excursions in Pediatric Subjects with Type 1 Diabetes Mellitus (T1DM): The DirecNet Experience.Pediatr Res 2003 Apr;53(4Pt2):1A-669A

  • Tsalikian E, Beck R, Ruedy K, Booth A, Tansey M, and the Diabetes Research in Children Network (DirecNet) Study Group. Glycemic Pattern of Insulin Induced Hypoglycemia in Pediatric Subjects with Type 1 Diabetes Mellitus (T1DM): The DirecNet Experience. Pediatr Res 2003 Apr;53(4Pt2):1A-669A

  • Buckingham B, Beck R, Tamborlane W, Ruedy K, Boland E, Chase P, Wysocki T, Tsalikian E, Wilson D, Mauras N, Weinzimer D, Tansey M, Fiallo-Scharer R, Booth A, Kollman C, and the Diabetes Research In Children Network (DirecNet) Study Group. Diabetes Research in Children Network (DirecNet) Accuracy Study of the Continuous Glucose Monitoring System (CGMS) and GlucoWatch® G2™ Biographer (GWB) in Children with Type 1 Diabetes-A CRC-based Study. Diabetes 2003 Jun;52 Suppl 1:A36.

  • Wilson D, Buckingham B, Beck R, Ruedy K, Kollman C, Tsalikian E, Wysocki T, Weinzimer S, Chase P, and the Diabetes Research in Children Network (DirecNet) Study Group. A 5-center CRC-based Study of the Accuracy of the GlucoWatch®G2™ Biographer in Children and Adolescents with Type 1 Diabetes. Diabetes 2003 Jun;52 Suppl 1:A101.

  • Boland E, Weinzimer S, Beck R, Ruedy K, Kollman C, Buckingham B, Chase P, Tansey M, Mauras N, and the Diabetes Research In Children Network (DirecNet) Study Group. Performance of the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) in Children with T1DM in the DirecNet Accuracy Study. Diabetes 2003 Jun;52 Suppl 1:A90.

  • Fiallo-Scharer R, Chase P, Beck R, Ruedy K, Booth A, Wysocki T, Boland E, Buckingham B, Tsalikian E, and the Diabetes Research In Children Network (DirecNet) Study Group. Performance of the One Touch Ultra at Different Glucose Levels in Three Age Groups of Children with T1DM in the CRC-DirecNet Accuracy Study. Diabetes 2003 Jun;52 Suppl 1:A562.

  • Mauras N, Beck RW, Ruedy KJ, Kollman C, Tamborlane WV, Chase HP, Buckingham BA, Tsalikian E, Weinzimer S, Booth AD, Xing D; Diabetes Research in Children Network (DirecNet) Accuracy Study. Lack of accuracy of continuous glucose sensors in healthy, nondiabetic children: results of the Diabetes Research in Children Network (DirecNet) accuracy study. J Pediatr. 2004 Jun;144(6):770-5. doi: 10.1016/j.jpeds.2004.03.042.

    PubMed 15192625

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Continuous Glucose Monitoring System (CGMS) and GlucoWatch G2TM Biographer (GW2B) in people with Diabetes Mellitus, run by Jaeb Center for Health Research at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of the GlucoWatch G2 Biographer and CGMS sensors. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00069602, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016; AzTrials last refreshed its copy on 1 Nov 2026.

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