Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

175

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach

2 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

Study Start

First participant enrolled

October 1, 2017

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed

15 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed

Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

October 23, 2017

Last Update Submit

March 28, 2022

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

iGFR at the end of the PERL trial
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.
Week 164 of the PERL trial

Secondary Outcomes (16)

HbA1c at week 80 of the PERL trial
Week 80 of the PERL Trial
HbA1c at week 96 of the PERL trial
Week 96 of the PERL Trial
HbA1c at week 112 of the PERL trial
Week 112 of the PERL Trial
HbA1c at week 128 of the PERL trial
Week 128 of the PERL Trial
HbA1c at week 142 of the PERL trial
Week 142 of the PERL Trial
+11 more secondary outcomes

Study Arms (2)

Allopurinol-treated

Participants in the PERL Clinical Trial (NCT02017171) randomized to allopurinol

Other: Mean blood glucoseOther: Blood glucose CVOther: % time 70-180 mg/dLOther: % time below 54 mg/dLOther: % time above 180 mg/dLOther: % time above 250 mg/dLOther: MAGE (Mean amplitude of glucose excursions)Other: LBGI (Low Blood Glucose Index)Other: HBGI (High Blood Glucose Index)Drug: Allopurinol

Placebo-treated

Participants in the PERL Clinical Trial (NCT02017171) randomized to placebo

Interventions

Mean blood glucoseOTHER

Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.