PERL Continuous Glucose Monitoring (CGM) Study



Status:Recruiting
Conditions:Diabetic Neuropathy
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 70
Updated:3/1/2019
Start Date:October 1, 2017
End Date:August 31, 2019
Contact:Sara Vecchi
Email:perlstudy@joslin.harvard.edu
Phone:(617) 309-4506

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PERL (Preventing Early Renal Loss in Diabetes) 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 (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.

Participants who consent to the study will have an Abbott Freestyle Libre Pro sensor placed
on the back of their upper arm at their first PERL visit after this ancillary study has begun
and at all subsequent PERL Visits. The sensor will be continuously worn by participants for
14 days. At the end of the 14 days, the sensor will be removed and mailed by the participant
to the Coordinating center. Since subjects are at various stages of the PERL protocol, the
number of remaining visits at which the CGM will be applied will vary among subjects.

STUDY AIMS

1. To assess the effect of glycemic variability, as measured by the coefficient of
variation of CGM glucose (CV, the ratio of standard deviation and the mean of CGM
glucose values), on the PERL renal functional endpoint (iohexol GFR at the end of
study).

2. To assess the effect of other glycemic parameters measured by CGM (mean glucose, % time
70-180 mg/dL, % time below 54 mg/dL, % time below 70 mg/dL, % time above 180 mg/dL, %
time above 250 mg/dL, mean amplitude of glucose excursions [MAGE], low blood glucose
index [LBGI], high blood glucose index [HBGI]) on the PERL renal functional endpoint.

3. To assess the relationship between CGM-measured glycemic parameters and HbA1c at various
levels of renal function.

4. To compare the effects of CGM metrics on the PERL renal endpoint and the corresponding
effect of HbA1c.

5. To assess the effect of allopurinol treatment on all of the different glycemic metrics
including HbA1c, CV, etc. and on their association with the PERL renal endpoint.

Inclusion Criteria:

• Being an active participant in the PERL clinical trial

Exclusion Criteria:

- Having completed PERL Visit 16

- Pregnancy

- History of skin reactions in relation to the application of Abbott Freestyle Libre Pro
We found this trial at
16
sites
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Principal Investigator: Alessandro Doria, MD PhD MPH
Phone: 617-309-2406
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Maria Luiza Caramori, MD, PhD
Phone: 612-626-3286
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Ian de Boer, MD
Phone: 206-685-4633
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Ann Arbor, Michigan 48105
Principal Investigator: Rodica Pop-Busui, MD, PhD
Phone: 734-936-8656
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Atlanta, Georgia
Principal Investigator: Guillermo Umpierrez, MD
Phone: 404-616-3951
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Aurora, Colorado 80045
Principal Investigator: Sarit Polsky, MD
Phone: 303-724-8369
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Bronx, New York 10461
Principal Investigator: Jill Crandall, MD
Phone: 718-405-8271
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Calgary, Alberta
Principal Investigator: Ronald Sigal, MD MPH
Phone: (403) 955-8119
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Mark Molitch, MD
Phone: 312-503-2873
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Dallas, Texas 75390
Principal Investigator: Ildiko Lingvay, MD MPH
Phone: 214-648-2515
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Detroit, Michigan 48202
Principal Investigator: Arti Bhan, MD
Phone: (313) 916-3906
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Carol Levy, MD
Phone: 212-241-9089
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Saint Louis, Missouri 63110
Principal Investigator: Janet McGill, MD
Phone: 314-362-8606
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Grace Lee, MD
Phone: 206-223-6169
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Spokane, Washington 99204
Principal Investigator: Katherine R. Tuttle, MD
Phone: 509-474-4962
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750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Ruth Weinstock, MD
Phone: 315-464-9006
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