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Diabetes Mellitus, Insulin-DependentPhase 4NCT00069628

Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer

A Phase 4 study testing GlucoWatch® G2™ Biographer (GW2B) and Continuous Glucose Monitoring System (CGMS) in people with Diabetes Mellitus, Insulin-Dependent, 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

This study will evaluate the safety and effectiveness of a continuous glucose monitor in children with Type 1 diabetes mellitus (T1DM). 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, Insulin-Dependent
What is being tested?
GlucoWatch® G2™ Biographer (GW2B) and Continuous Glucose Monitoring System (CGMS)
Type of treatment
Medical device
How many people
200 participants
Where
6 sitesUnited States
Study dates
Jul 2003to Nov 2004
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

  • Clinical diagnosis of type 1 diabetes
  • Insulin therapy (either a pump or at least 2 injections per day) for at least one year prior to study entry
  • HbA1c between 7.0 and 11.0%
  • Stable insulin regimen for the 2 months prior to study entry and 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)
  • Agree to comply with study requirements, including the performance of at least 4 fingerstick glucose checks a day using a home glucose monitor
  • Comprehend written English
  • Female participants must not intend to become pregnant during the next 6 months
  • Plan to remain in the area of the clinical center during the next 6 months

Who cannot join

None listed.

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 Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer in the Management of Type 1 Diabetes in Children

This study will evaluate the safety and effectiveness of a continuous glucose monitor in children with Type 1 diabetes mellitus (T1DM).

Read the detailed description

Intensive control of blood glucose levels has been shown to substantially prevent or delay complications of T1DM in adolescents and adults. The major limitation to implementation of intensive glycemic control is hypoglycemia. Younger children may be at increased risk for hypoglycemia, and the risk/benefit ratio of intensive glycemic control may be less favorable in this population. The Diabetes Research in Children Network (DirecNet) was established to evaluate the feasibility and effectiveness of intensive glycemic control in children with T1DM.

This study is designed to evaluate glycemic control, hypoglycemia, and quality of life when using a GlucoWatch G2TM Biographer (GW2B) versus standard care. Children in the study will use the GW2B in their home environment in order to assess if the GW2B can help to safely lower blood sugar levels (as measured by the glycosylated hemoglobin test), to learn how using the GW2B affects the daily lives of children with diabetes, and to find out if there are any drawbacks to using the GlucoWatch.

As part of the study, participants in the intervention group will also use a second glucose monitoring device called the Continuous Glucose Monitoring System (CGMS). The CGMS will be inserted at baseline and at Months 3 and 6; it will be worn for three days after each visit. The CGMS will be used to measure changes in biochemical hypoglycemia.

Participants at five participating centers will include a total of 200 children and adolescents with type 1 diabetes. Of the 200 children, 100 will be randomized to wear the GW2B and 100 will be randomized to usual care without GW2B. Each patient will be provided with a personal computer for weekly downloading of data and completion of questionnaires regarding hypoglycemia. Phone contacts will be made with the patients after Weeks 1, 2, and 4, then every 4 weeks to review their diabetes management. At Months 3, 6, 9 and 12, a follow-up visit will be performed to measure HbA1c. The CGMS sensor will be inserted to assess hypoglycemia at baseline and Months 3 and 6. At the 6-month follow-up visit, psychosocial questionnaires will also be administered.

Being tested
GlucoWatch® G2™ Biographer (GW2B), Continuous Glucose Monitoring System (CGMS)
Keywords
Diabetes Mellitus, Insulin-Dependent, Type 1 Diabetes, Diabetes in Children, Continuous Glucose Monitoring Devices
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • GlucoWatch® G2™ Biographer (GW2B)Device

  • Continuous Glucose Monitoring System (CGMS)Device

What is being measured

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

  1. HbA1c value obtained 6 months after randomization

Secondary outcomes (4)

  1. Number of hypoglycemic events during 6 months

  2. Diabetes Worry Scale at 6 months

  3. PedsQL Diabetes Module at 6 months

  4. Diabetes Self Management Profile at 6 months

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 startJul 2003
  3. Study completionNov 2004

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
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069628
Sponsor's protocol ID
DirecNet 004
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

  • Tansey MJ, Beck RW, Buckingham BA, Mauras N, Fiallo-Scharer R, Xing D, Killman C, Tamborlane WV, Ruedy KJ; Diabetes Research in Children Network (DirecNet) Study Group. Accuracy of the modified Continuous Glucose Monitoring System (CGMS) sensor in an outpatient setting: results from a diabetes research in children network (DirecNet) study. Diabetes Technol Ther. 2005 Feb;7(1):109-14. doi: 10.1089/dia.2005.7.109.

    PubMed 15738708

  • Tamborlane WV, Kollman C, Steffes MW, Ruedy KJ, Dongyuan X, Beck RW, Chase P, Fox LA, Wilson DM, Tsalikian E; Diabetes Research in Children Network (DirecNet) Study Group. Comparison of fingerstick hemoglobin A1c levels assayed by DCA 2000 with the DCCT/EDIC central laboratory assay: results of a Diabetes Research in Children Network (DirecNet) Study. Pediatr Diabetes. 2005 Mar;6(1):13-6. doi: 10.1111/j.1399-543X.2005.00088.x.

    PubMed 15787896

  • Chase HP, Beck R, Tamborlane W, Buckingham B, Mauras N, Tsalikian E, Wysocki T, Weinzimer S, Kollman C, Ruedy K, Xing D. A randomized multicenter trial comparing the GlucoWatch Biographer with standard glucose monitoring in children with type 1 diabetes. Diabetes Care. 2005 May;28(5):1101-6. doi: 10.2337/diacare.28.5.1101.

    PubMed 15855573

  • Fiallo-Scharer R; Diabetes Research in Children Network Study Group. Eight-point glucose testing versus the continuous glucose monitoring system in evaluation of glycemic control in type 1 diabetes. J Clin Endocrinol Metab. 2005 Jun;90(6):3387-91. doi: 10.1210/jc.2004-2510. Epub 2005 Mar 22.

    PubMed 15784705

  • Diabetes Research in Children Network (DirecNet) Study Group. Diabetes self-management profile for flexible insulin regimens: cross-sectional and longitudinal analysis of psychometric properties in a pediatric sample. Diabetes Care. 2005 Aug;28(8):2034-5. doi: 10.2337/diacare.28.8.2034. No abstract available.

    PubMed 16043752

  • Diabetes Research in Children Network (DirecNet) Study Group. Youth and parent satisfaction with clinical use of the GlucoWatch G2 Biographer in the management of pediatric type 1 diabetes. Diabetes Care. 2005 Aug;28(8):1929-35. doi: 10.2337/diacare.28.8.1929.

    PubMed 16043734

  • William Tamborlane, Dongyuan Xing, Michael Steffes, Craig Kollman, Katrina Ruedy, Roy Beck, Rosanna Fiallo-Scharer, Larry Fox, Darrell Wilson, Eva Tsalikian, and the Diabetes Research In Children Network (DirecNet) Study Group: Performance of the DCA2000 for Measurement of Hemoglobin A1c Levels in Children with T1DM in a DirecNet Outpatient Clinical Trial. Pediatr Res 2004; 55 (4 Pt 2):138A.

  • Michael Tansey, Roy Beck, Bruce Buckingham, Nelly Mauras, Rosanna Fiallo-Scharer, Dongyuan Xing, Craig Kollman, William Tamborlane, Katrina Ruedy, and the Diabetes Research in Children Network (DirecNet) Study Group: A Comparison of the Original vs. Modified Continuous Glucose Monitoring System (CGMS) Sensor During Using Data from Two DirecNet Studies. Diabetes 2004; 53(Suppl 2):A465.

  • Rosanna Fiallo-Scharer, Dongyuan Xing, Stuart Weinzimer, Bruce Buckingham, Nelly Mauras, Michael Tansey, Roy Beck, Katrina Ruedy, Craig Kollman, William Tamborlane, and the Diabetes Research in Children Network (DirecNet) Study Group: Utility of CGMS as a Measure of Glycemic Control in Children with Type 1 Diabetes (T1DM). Diabetes 2004; 53(Suppl 2):A67.

  • Peter Chase, Dongyuan Xing, Stuart Weinzimer, Bruce Buckingham, Nelly Mauras, Michael Tansey, Roy Beck, Katrina Ruedy, Craig Kollman, William Tamborlane, and the Diabetes Research in Children Network (DirecNet) Study Group: Comparison of 8-point Glucose Testing with Glycemic Control in Children with Type 1 Diabetes (T1DM). Diabetes 2004; 53(Suppl 2):A600.

  • Tim Wysocki, Dongyuan Xing, Rosanna Fiallo-Scharer, Elizabeth Doyle, Jennifer Block, Eva Tsalikian, Roy Beck, Katrina Ruedy, Craig Kollman, William Tamborlane, and the Diabetes Research in Children Network (DirecNet) Study Group: Diabetes Self-Management Profile-Revised for Conventional and Flexible Insulin Regimens. Diabetes 2004; 53(Suppl 2):A436.

  • H. Peter Chase, Roy Beck, William Tamborlane, Bruce Buckingham, Nelly Mauras, Eva Tsalikian, Tim Wysocki, Stuart Weinzimer, Katrina Ruedy, Dongyuan Xing, and the Diabetes Research in Children Network (DirecNet) Study Group: Lack of Effectiveness of the GlucoWatch G2 Biographer in Altering Glycemic Control in Children with Type 1 Diabetes. Diabetes Technol Ther 2005; 7(2):370.

  • Darrell Wilson, Rosanna Fiallo-Scharer, Dongyuan Xing, Tim Wyscoki, Jennifer Block, Stu Weinzimer, Craig Kollman, Roy Beck, Katrina Ruedy, William Tamborlane, and the Diabetes Research in Children Network (DirecNet) Study Group: Reliability of Two Indices of the Biologic Variability in Glycosylation among Children and Adolescents with T1DM. Diabetes 2005; 54(Suppl 1):A454.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing GlucoWatch® G2™ Biographer (GW2B) and Continuous Glucose Monitoring System (CGMS) in people with Diabetes Mellitus, Insulin-Dependent, 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 8 inclusion and 0 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?

HbA1c value obtained 6 months after randomization. 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 NCT00069628, which also lists 13 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.

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