Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT00284232
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2006-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Accurate Blood Sugar Results and Education in Type 1 Diabetes
Sponsor:
Helse Stavanger HF
Organization:
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 0,5% 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 \<1,5%
* 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, 1,2,3,6 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 \<1,5%
* 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, 1,2,3,6 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:
False
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?: