Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284232
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2006-01-27
Brief Title:
Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
Sponsor:
Helse Stavanger HF
Organization:
Helse Stavanger HF
Study Overview
Official Title:
Randomized Controlled Trial Studying the Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2015-07
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:
A randomized controlled trial in patients with type 1 diabetes assessing the metabolic effects of accurate blood sugar results and education A systematic approach in self-monitoring blood glucose will improve metabolic control in type 1 diabetes patients Education in SMBG combined with a high analytical quality instrument for SMBG introduced in a systematic and thorough way will improve HbA1c by 05 and keep it over a period of 9 months
Detailed Description:
Written informed consent 130 patients with type 1 diabetes to be included
age 18-70
HbA1c of 8 or higher variation in HbA1c over the last 18 months sholuld be 15
Treated with multiple insulin injections or insulin pumps
Variation in weight less than 5kg within last year
Using SMBG on a daily basis
Mental capacity and stability to participate
No hypoglycemia unawareness
No likelihood that patient will drop out or not perform according to protocol
Continious recruitment from the outpatient clinic at Stavanger University Hospital from October 2004-October 2005
9 months follow-up
Possible 12 month extension after initial
Intervention group receives new SMBG instrument education and advice on treatment changes at baseline 1236 and 9 months Control group continues regular care following national guidelines of Norway This includes visits usually every 3-6 months at the outpatient clinic and possibly with their GP in addition
age 18-70
HbA1c of 8 or higher variation in HbA1c over the last 18 months sholuld be 15
Treated with multiple insulin injections or insulin pumps
Variation in weight less than 5kg within last year
Using SMBG on a daily basis
Mental capacity and stability to participate
No hypoglycemia unawareness
No likelihood that patient will drop out or not perform according to protocol
Continious recruitment from the outpatient clinic at Stavanger University Hospital from October 2004-October 2005
9 months follow-up
Possible 12 month extension after initial
Intervention group receives new SMBG instrument education and advice on treatment changes at baseline 1236 and 9 months Control group continues regular care following national guidelines of Norway This includes visits usually every 3-6 months at the outpatient clinic and possibly with their GP in addition
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