Status:
COMPLETED
Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested in Patients With Type 1 Diabetes and Renal Impairment
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Diabetes Mellitus Complication
Renal Impairment
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The study aims to evaluate the accuracy of two commercial glucose monitoring systems in patients with type 1 or type 2 diabetes and renal impairment, including patients with or without dialysis. Patie...
Detailed Description
Continuous glucose monitoring (CGM) and Flash glucose monitoring (FGM) are tools today mainly used in the treatment of patients with type 1 diabetes. Both glucose monitors are subcutaneous tissue sens...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Type 1 or type 2 diabetes with renal impairment and eGFR \<30 ml/min measured within the last three months.
- Adult patients, age 18 or older and \<80 years.
- Written Informed Consent
- Exclusion criteria:
- Pregnancy
- Patients with severe cognitive dysfunction or other disease which makes glucose monitoring use difficult.
- Patients requiring continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during the duration because it disturbs the interpretation of blood glucose levels estimated by the Dexcom G5. However, other pain killers can be used throughout the study period.
- Current CGM or FGM use.
- History of allergic reaction to any of the CGM or FGM materials or adhesives in contact with the skin.
- History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
- Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
- Patients with renal impairment and eGFR greater or equal to 30 ml/min estimated by the MDRD formula.
Exclusion
Key Trial Info
Start Date :
May 5 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03378271
Start Date
May 5 2016
End Date
December 31 2022
Last Update
February 29 2024
Active Locations (1)
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1
NU-Hospital Group
Uddevalla, Sweden, 45180