An observational study in Diabetes Mellitus and Atrial Fibrillation, sponsored by Region Gävleborg. Status unknown at 1 site in Sweden. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-12-30.
Sponsored by Region Gävleborg · Observational
Among 168 studies in Diabetes Mellitus with a site in Sweden — 16 open to participants now, 19 under way, 1 of them phase 3. Diabetes Mellitus · Sweden.
Among the 168 studies in Diabetes Mellitus with a site in Sweden, this one is the 17th largest by planned enrollment of the 35 observational ones, is one of 3 that started in 2021, is one of 36 observational ones, and was the 147th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 600 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →16 of the 168 studies in Diabetes Mellitus with a site in Sweden are open now, in 12 countries. Each count lists the studies.
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 65 Years and older · all sexes.
The full table on the hub →168 studies; the count open now beside each. This study's row is marked.
First in 1989; this study’s year is marked. 3 started in 2021.
Median enrollment 165 across the 132 interventional studies, 500 across the 35 observational. Of the 127 that completed or were terminated, 40 (31%) have results posted.
97 of 168 have an industry lead sponsor. The 10 most frequent:
Region Gävleborg is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
Region Gävleborg has 1 study filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
4 of the studies in Diabetes Mellitus with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05810311Region StockholmThe Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy | 2027-01-01 |
| NCT07426224Folktandvården Stockholms län ABBlood Glucose Screening in Patients With Advanced Periodontits: the Role of Specialist Periodontal Care in Identifying Hyperglycaemia and Supporting Patient Centered Treatment | 2027-03-01 |
| NCT05317130Lund UniversityA Complex Health Promotion Intervention in Parasport - The Safe & Healthy Parasport Project | 2027-09-01 |
| NCT06452654Technical University of MunichAnti-viral Action Against Type 1 Diabetes Autoimmunity | 2027-10 |
Among the 168 studies in Diabetes Mellitus with a site in Sweden, from their registry updates:
Cardiac thromboembolism attributed to atrial fibrillation (AF) constitutes at least one-third of ischemic strokes. Indeed, stroke may be the first manifestation of previously undetected AF. The prevalence is projected to increase 20% the coming decades, especially in age group 65 years and above of age. To add to incidence, the diabetic population have an increased risk yet not properly investigated. In patients with confirmed AF, assessment using the CHA2DS2-VASc score (congestive heart failure, hypertension, age 65 years and above, diabetes mellitus, stroke, vascular disease, age 75 years and above, sexual category), is applied for risk stratification. If the CHA2DS2-VASc score is at least 1, or definitely 2 points typically a non-vitamin K antagonist oral anticoagulant (NOAC) should be prescribed. The chest- and thumb-electrocardiogram (ECG) system Coala Heart Monitor has proven efficacious in detecting AF following recent cryptogenic stroke. This system also showed to be feasible from a patient perspective. Thus, in patients aged 65 years and above with diabetes mellitus at least 2 points are reached. Therefore, patient with these risk factors should be considered for further evaluation for NOAC to prevent stroke, which provides the rational for this study.
Cardiac thromboembolism attributed to atrial fibrillation (AF) constitutes at least one-third of ischemic strokes.The prevalence is projected to increase 20% the coming decades, especially in age group 65 years and above of age. To add to incidence, the diabetic population have an increased risk yet not properly investigated. In patients with confirmed AF, assessment using the CHA2DS2-VASc score (congestive heart failure, hypertension, age 65 years and above, diabetes mellitus, stroke, vascular disease, age 75 years and above, sexual category) , is applied for risk stratification. If the CHA2DS2-VASc score is at least 1, or definitely 2 points typically a Non-vitamin K antagonist Oral AntiCoagulants (NOAC) should be prescribed. The chest- and thumb-electrocardiogram (ECG) system Coala Heart Monitor will be used to detect AF, which showed to be feasible from a patient perspective. Thus, in patients aged 65 years and above with diabetes mellitus at least 2 points are reached. Therefore, patient with these risk factors should be considered for further evaluation for NOAC to prevent stroke, which provides the rational for this study.
Unselected patients with diabetes type 1 or type 2 at an age of 65 years and above.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
thumb- and chest-ECG
Number of participants with the diagnosis of atrial fibrillation
Incidence of atrial fibrillation during the monitoring period
Time frame: 90 days
Patient-reported symptoms (descriptive category variables) of atrial fibrillation using a questionnaire in a digital application
Symptoms (questionnaire with the following categories of answers: palpitation, dizziness, dyspnea, chest pain, other) when atrial fibrillation is diagnosed using the patient report (in the digital application with the mentioned categories of symptoms predefined) at the time of ECG transmission.
Time frame: 90 days
Plan to share: No
Started Sep 2021 (actual). Primary completion is estimated for Apr 2022, 7 months after the start.
Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 175. This study's planned 7 months is below that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Region Gävleborg