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NCT03334318 · ClinicalTrials.gov registry record
PERL Continuous Glucose Monitoring (CGM) Study
A clinical trial, sponsored by Joslin Diabetes Center.
- Completed
- Registry status
- 175
- Enrollment target
NCT03334318: Completed study, sponsored by Joslin Diabetes Center.
NCT03334318 is a clinical trial that has completed, run by Joslin Diabetes Center. The registered enrollment target is 175 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03334318 has completed, sponsored by Joslin Diabetes Center.
- COMPLETED
- Registry status
- 175 participants
- Enrollment target
Study Summary
Seven-point capillary profiles have shown that mean glucose correlates with both diabetic retinopathy and nephropathy risk. However, there remains great controversy as to whether the degree of variability around mean glucose may also contribute to these microvascular complications. The PERL trial (NCT02017171), testing whether treatment with allopurinol can slow down kidney function loss in type 1 diabetes, provides a unique opportunity to assess the role of glycemic variability in the progression of diabetic kidney disease in individuals who already have mild to moderate kidney disease. By applying Continuous Glucose Monitoring (CGM) in the PERL Study population, the investigators will be able to better understand how metrics of glycemia (mean, time above and below range, and various measures of variability) are associated with renal outcomes in the PERL population as a whole, but also in important subgroups (e.g., albuminuric vs. normoalbuminuric subjects with ongoing GFR decline, allopurinol vs. placebo arms). The nvestigators also aim to obtain precise information on the range of blood glucose corresponding to any given HbA1c value in this population since previous studies generally excluded patients with renal disease.
Primary Outcome
Glomerular filtration rate (GFR) at the end of the PERL trial, measured by the plasma clearance of non-radioactive iohexol (iGFR) and adjusted for the iGFR at baseline.
Interventions
- OTHER Mean blood glucose
- OTHER Blood glucose CV
- OTHER % time 70-180 mg/dL
- OTHER % time below 54 mg/dL
- OTHER % time above 180 mg/dL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2021-12-31 |
What the finished NCT03334318 record still lists
NCT03334318 is an observational study that tracks outcomes without assigning an intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which Mean blood glucose is the first listed.
NCT03334318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03334318 about?
NCT03334318 is a clinical study titled "PERL Continuous Glucose Monitoring (CGM) Study". Seven-point capillary profiles have shown that mean glucose correlates with both diabetic retinopathy and nephropathy risk. However, there remains great controversy as to whether the degree of variability around mean glucose may also contribute to these microvascular complications. The PERL trial (N...
What is the current status of trial NCT03334318?
This trial is currently completed. The enrollment target is 175 participants. The study started on 2017-10-01. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT03334318?
The interventions under investigation include: Mean blood glucose (OTHER), Blood glucose CV (OTHER), % time 70-180 mg/dL (OTHER), % time below 54 mg/dL (OTHER), % time above 180 mg/dL (OTHER).
Who is sponsoring clinical trial NCT03334318?
This trial is sponsored by Joslin Diabetes Center, which has 73 total clinical trials registered on ClinicalTrials.gov.
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