Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069615
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2003-09-29
Brief Title:
Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
DirecNet Pilot Study to Evaluate the GlucoWatch G2 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:
Devices such as the GlucoWatch G2 Biographer GW2B which constantly measure blood sugar levels may improve the treatment of Type 1 diabetes mellitus in children This study evaluated the GW2B when used by children in their homes
Detailed Description:
The proper role of the GW2B in the management of Type 1 diabetes in children has not been determined As a prelude to a large-scale randomized clinical trial RCT to compare the effect on glycemic control hypoglycemia and quality of life of using a GW2B versus standard care the DirecNet Study Group conducted a pilot study to assess the feasibility of the protocol planned for the RCT and to collect data on changes in HbA1c frequency of hypoglycemia frequency of skin reactions and quality of life after using the GW2B for three months
Fifteen children and adolescents with Type 1 diabetes participated in this study Each patient was provided with a personal computer for weekly downloading of the GW2B and for completion of questionnaires regarding hypoglycemia and GW2B use Participants received study telephone calls after 1 2 and 4 weeks and every 4 weeks thereafter to review their diabetes management Participants had a follow-up visit at Week 29 The Continuous Glucose Monitoring System was inserted at this visit to assess hypoglycemia over three days A follow-up visit was performed at Week 30 to measure HbA1c and administer psychosocial questionnaires
Fifteen children and adolescents with Type 1 diabetes participated in this study Each patient was provided with a personal computer for weekly downloading of the GW2B and for completion of questionnaires regarding hypoglycemia and GW2B use Participants received study telephone calls after 1 2 and 4 weeks and every 4 weeks thereafter to review their diabetes management Participants had a follow-up visit at Week 29 The Continuous Glucose Monitoring System was inserted at this visit to assess hypoglycemia over three days A follow-up visit was performed at Week 30 to measure HbA1c and administer psychosocial questionnaires
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 |