Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069628
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2003-09-29
Brief Title:
Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
DirecNet Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer in the Management of Type 1 Diabetes in Children
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and effectiveness of a continuous glucose monitor in children with Type 1 diabetes mellitus T1DM
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 riskbenefit 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HD041915 | None | None | None |
| HD041890 | None | None | None |
| HD041919-01 | None | None | None |
| HD041908-01 | None | None | None |
| HD041906-01 | None | None | None |
| HD041918-01 | None | None | None |