Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service (AGS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03306810|
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
AGS (Acute Glucose Service ) is an inpatient glucose management service consisting of Nurse Practitioner and physician. Team manages not - consulted- based preoperative assessment, perioperative glucose control, patient education and supervision, but also transition of care postoperatively. The goal is to detect and treat dysglycemias , but also provide an active and constantly ongoing education to other hospital teams.
AGS improves better overall- survival of arthroplastic patients and is an effective way to recognize and treat dysglycemias and to organize constantly ongoing education.
|Condition or disease||Intervention/treatment||Phase|
|Dysglycemia Arthroplasty Complications||Other: AG service||Not Applicable|
600 elective knee and hip arthroplastic patients are collected. 200 patients before AG- service will be compared to 400 patients after AGS. The latter group is divided to two 200 patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may be contacted by phone). Patients are followed up up to 5 years. Controls will be held after 3 months, 1 year and 5 years after operation including B-Hba1c, 15 D Quality of life assessment and patient interview.
There are several aims of the team and study: to detect, diagnose and optimize treatment (including medication) of diabetic/ dysglycemic patients from preoperative assessment 1 week before operation to postoperative care. With blood glucose target 42 - 86 mmol/mol results better overall survival, lesser complications (i.e. infections, cardiovascular or renal complications) and shorter length of hospital stay. Other aim is to find undiagnosed diabetics or those at risk of developing diabetes. One aim is to find risk factors, which lead to stress hyperglycemia during perioperative period or diabetes in 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recognition and Treatment of Dysglycemia in Elective Knee and Hip Arthroplasties. AGS - Acute Glucose Service|
|Actual Study Start Date :||September 26, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2025|
Active Comparator: AG service
In the "Active Comparator Arm": Screening, follow-up and treatment of dysglycemias in the elective orthopedic prosthetic surgery (knee / hip) patients in the Päijät-Häme Central hospital will be optimized and individualized in the patients in personal manner.
Other: AG service
The AG service group is divided to two 200 patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may be contacted by phone). Patients are followed up up to 5 years.
No Intervention: Without AG service
In the "No intervention Arm": Screening, follow-up and treatment of dysglycemias in the elective orthopedic prosthetic surgery (knee / hip) patients follows the current protocol of Päijät-Häme Central hospital.
- Survival [ Time Frame: 1-5 years ]Improved survival
- Complications [ Time Frame: 1-5 years ]Less complications after AG-service
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306810
|Contact: Marianne Ylikoski, MDemail@example.com|
|Contact: Raine Tiihonen, MD, PhDfirstname.lastname@example.org|
|Päijät-Häme Central Hospital||Recruiting|
|Lahti, Finland, 15850|
|Contact: Marianne Ylikoski, MD +358447195268 email@example.com|
|Contact: Raine Tiihonen, MD, PhD +3584406151 firstname.lastname@example.org|
|Principal Investigator:||Marianne Ylikoski, MD||Päijänne Tavastia Central Hospital|