Trials / Completed
CompletedNCT04011683
Hypoglycaemia and Cardiac Arrhythmias in Type 1 Diabetes
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- Steno Diabetes Center Copenhagen · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The investigators hypothesise that patients with type 1 diabetes have clinically relevant, but often unrecognised, episodes of arrhythmias linked to episodes of hypoglycaemia and/or clinically significant fluctuations in plasma glucose.
Detailed description
30 patients with type 1 diabetes will be recruited for a one-year observational study employing CGM (Continuous glucose monitor) and ILR (Implantable loop recorder). Patients will be scheduled for a three-week run-in period to ensure that the implanted ILR provides reliable data. Patient visits are planned for 0, 3, 6, 9, and 12 months and will include clinical examination, blood and urine samples, echocardiography (only first and last visit) and implant/explant of CGM. After 12 months, the participants will continue with an extended observation period of 2 years employing ILR and clinical examination. Device: Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA) Implantation of a loop-recorder Device: Continuous glucose monitoring (Eversense XL, Senseonics, USA) Monitoring with a continuous glucose monitor
Conditions
- Hypoglycemia (Diabetic)
- Hyperglycaemia (Diabetic)
- Arrythmia, Cardiac
- Type 1 Diabetes
- Blood Glucose Fluctuations
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2021-12-20
- Completion
- 2021-12-20
- First posted
- 2019-07-08
- Last updated
- 2022-01-18
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04011683. Inclusion in this directory is not an endorsement.