Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362193
Status:
COMPLETED
Last Update Posted:
2010-02-15
First Post:
2006-08-07
Brief Title:
Glycemic Relapse Prevention Maintenance Dose Assessment
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Longitudinal Diabetes Care A Randomized Controlled Trial to Prevent Glycemic Relapse
Status:
COMPLETED
Status Verified Date:
2010-02
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 purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse
Detailed Description:
Recent large randomized controlled trials have proven that tight glycemic control reduces the microvascular and macrovascular complications of diabetes Reduction of these complications also leads to a great cost savings to healthcare and society However it has been difficult to translate the success of these large randomized control trials to everyday practice A recent cross-sectional analysis of 95 clinicians revealed only 405 of type 2 diabetes patients had a glycated hemoglobin HbA1c less than 7 The disparity of care between the large trials and a primary care office is largely due to the difference in resources available in the typical medical office Practical sustainable ways of maintaining tight glycemic control are needed in everyday practice
While diabetes improvement programs are successful in acutely lowering HbA1c the long-term effectiveness of these programs is disappointing Approximately 40 of those who return to routine care after completing an intensive diabetes improvement program experience a relapse in their glycemic control within one year Some proportion of the relapse is likely due to a patients inability to maintain adherence to key self-care behaviors - diet exercise self-monitoring of blood glucose and medication regimen
The purpose of this study is to better understand prevention of glycemic relapse The primary aim of this study is to assess the relative effectiveness of three management approaches varying in frequency for preventing glycemic relapse after glycemic control has been achieved through participation in an intensive diabetes improvement program This study will determine the optimal frequency of intervention needed to prevent glycemic relapse in patients with type 2 diabetes The authors hypothesize that high intensity intervention will lead to a decrease in glycemic relapse in a dose dependent fashion
While diabetes improvement programs are successful in acutely lowering HbA1c the long-term effectiveness of these programs is disappointing Approximately 40 of those who return to routine care after completing an intensive diabetes improvement program experience a relapse in their glycemic control within one year Some proportion of the relapse is likely due to a patients inability to maintain adherence to key self-care behaviors - diet exercise self-monitoring of blood glucose and medication regimen
The purpose of this study is to better understand prevention of glycemic relapse The primary aim of this study is to assess the relative effectiveness of three management approaches varying in frequency for preventing glycemic relapse after glycemic control has been achieved through participation in an intensive diabetes improvement program This study will determine the optimal frequency of intervention needed to prevent glycemic relapse in patients with type 2 diabetes The authors hypothesize that high intensity intervention will lead to a decrease in glycemic relapse in a dose dependent fashion
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 |
|---|---|---|---|
| P60DK020593 | NIH | None | httpsreporternihgovquickSearchP60DK020593 |