DysglycemiaAGSNCT03306810
Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service
A study testing AG service in people with Dysglycemia and Arthroplasty Complications, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysglycemia, Arthroplasty Complications
- What is being tested?
- AG service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFinland
- Study dates
- 26 Sep 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged > 18 years
- Elective knee and hip arthroplasty patients
Who cannot join
- Patients who are incompetent to give informed consent
- Patients who are incompetent to assess their Quality-of-Life personally
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Päijät-Häme Central Hospital
Lahti, 15850
Marianne Ylikoski, MD, +358447195268, marianne.ylikoski@phhyky.fi
Raine Tiihonen, MD, PhD, +3584406151, raine.tiihonen@phhyky.fi
About this study
Official title: Recognition and Treatment of Dysglycemia in Elective Knee and Hip Arthroplasties. AGS - Acute Glucose Service
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.
Read the detailed description
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.
- Conditions
- Dysglycemia, Arthroplasty Complications
- Being tested
- AG service
- Keywords
- Perioperative complications, Dysglycemia management team, Nurse Practitioner, Hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG serviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AG service | Active comparator | 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. Receives: Other: AG service |
| Without AG service | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Improved survival
Measured: 1-5 years
Secondary outcomes (1)
Complications
Less complications after AG-service
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start26 Sep 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marjo Soini, Joint Authority for Päijät-Häme Social and Health Care
- Investigators
- Marianne Ylikoski, MD, Principal investigator, Päijät Häme Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306810
- Sponsor's protocol ID
- Q321dnro 47/17
- Acronym
- AGS
- Status last verified
- Oct 2017
- First submitted
- 19 Sep 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ylikoski M, Jokinen JJ, Lahtela J, Kauppi MJ, Huhtala H, Immonen H, Tiihonen R. Perioperative hyperglycaemia in elective arthroplasties. Should we do better? Acta Anaesthesiol Scand. 2020 Oct;64(9):1253-1261. doi: 10.1111/aas.13666. Epub 2020 Jul 30.
PubMed 32615649
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognition and Treatment of Dysglycemia in Elective Knee and Hip Arthroplasties. AGS - Acute Glucose Service
- ClinicalTrials.gov ID
- NCT03306810
- Acronym / sponsor ID
- AGS / Q321dnro 47/17
- Conditions
- Dysglycemia, Arthroplasty Complications
- Keywords
- Perioperative complications, Dysglycemia management team, Nurse Practitioner, Hospital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AG service | Active comparator | Other: AG serviceIn 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. |
| Without AG service | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged > 18 years
- Elective knee and hip arthroplasty patients
Key exclusion criteria (2 listed)
- Patients who are incompetent to give informed consent
- Patients who are incompetent to assess their Quality-of-Life personally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG serviceThe 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. | Other | AG service |
Primary outcome
Survival
Time frame: 1-5 years
Improved survival
1 secondary outcome
Complications
Time frame: 1-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Derived from this study: PubMed 32615649Ylikoski M, Jokinen JJ, Lahtela J, Kauppi MJ, Huhtala H, Immonen H, Tiihonen R. Perioperative hyperglycaemia in elective arthroplasties. Should we do better? Acta Anaesthesiol Scand. 2020 Oct;64(9):1253-1261. doi: 10.1111/aas.13666. Epub 2020 Jul 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Ylikoski, MD principal investigator
Päijät Häme Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AG service in people with Dysglycemia and Arthroplasty Complications, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Ylikoski, MD (+358447195268, marianne.ylikoski@phhyky.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03306810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.