PERL Continuous Glucose Monitoring (CGM) Study

Diabetic Nephropathies Clinical Trial

Official title:

PERL (Preventing Early Renal Loss in Diabetes) Continuous Glucose Monitoring (CGM) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334318
• Other study ID #: 2018PG-T1D014
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies

Intervention

Other:
• Mean blood glucose
Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
• Blood glucose CV
Coefficient of variation of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
• % time 70-180 mg/dL
Percent of time with blood glucose in the 70-180 mg/dL range as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
• % time below 54 mg/dL
Percent of time with blood glucose below 54 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
• % time above 180 mg/dL
Percent of time with blood glucose above 180 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
• % time above 250 mg/dL
Percent of time with blood glucose above 250 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
• MAGE (Mean amplitude of glucose excursions)
Mean amplitude of glucose excursions as measured by continuous glucose monitoring as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
• LBGI (Low Blood Glucose Index)
Low blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
• HBGI (High Blood Glucose Index)
High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Drug:
• Allopurinol
Oral allopurinol tablets administered in the PERL Clinical Trial
• Placebo
Oral placebo tablets administered in the PERL Clinical Trial

Locations

Country	Name	City	State
Canada	Unversity of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	University of Toronto	Toronto	Ontario
Canada	BC Diabetes	Vancouver	British Columbia
United States	Brehm Center for Diabetes Research / University of Michigan	Ann Arbor	Michigan
United States	Emory University - Grady Memorial Hospital	Atlanta	Georgia
United States	Barbara Davis Center / University of Colorado Denver	Aurora	Colorado
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Albert Einstein College of Medicine / Montefiore Medical Center	Bronx	New York
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	UT Southwestern Dallas	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Minnesota	Minneapolis	Minnesota
United States	ICAHN School of Medicine at Mount Sinai	New York	New York
United States	Washington University	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Providence Sacred Heart Medical Center	Spokane	Washington
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (10)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Albert Einstein College of Medicine, Feinberg School of Medicine, Northwestern University, Providence Medical Research Center, The Leona M. and Harry B. Helmsley Charitable Trust, University of Colorado, Denver, University of Michigan, University of Minnesota, University of Washington, Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c at week 80 of the PERL trial	Hba1c value at week 80 of the PERL trial	Week 80 of the PERL Trial
Secondary	HbA1c at week 96 of the PERL trial	Hba1c value at week 96 of the PERL trial	Week 96 of the PERL Trial
Secondary	HbA1c at week 112 of the PERL trial	Hba1c value at week 112 of the PERL trial	Week 112 of the PERL Trial
Secondary	HbA1c at week 128 of the PERL trial	Hba1c value at week 128 of the PERL trial	Week 128 of the PERL Trial
Secondary	HbA1c at week 142 of the PERL trial	Hba1c value at week 142 of the PERL trial	Week 142 of the PERL Trial
Secondary	HbA1c at week 156 of the PERL trial	Hba1c value at week 156 of the PERL trial	Week 156 of the PERL Trial
Secondary	HbA1c at week 164 of the PERL trial	Hba1c value at week 164 of the PERL trial	Week 164 of the PERL Trial
Secondary	Mean blood glucose	Mean of blood glucose values measured by continuous glucose monitoring	From week 80 to week 164 of the PERL trial
Secondary	CV (coefficient of variation) of blood glucose	Coefficient of variation of blood glucose values measured by continuous glucose monitoring	From week 80 to week 164 of the PERL trial
Secondary	% time 70-180 mg/dL	Percentage of time with blood glucose in the 70-180 mg/dL range (as measured by continuous glucose monitoring)	From week 80 to week 164 of the PERL trial
Secondary	% time below 54 mg/dL	Percentage of time with blood glucose below 54 mg/dL (as measured by continuous glucose monitoring)	From week 80 to week 164 of the PERL trial
Secondary	% time above 180 mg/dL	Percentage of time with blood glucose above 180 mg/dL (as measured by continuous glucose monitoring)	From week 80 to week 164 of the PERL trial
Secondary	% time above 250 mg/dL	Percentage of time with blood glucose above 250 mg/dL (as measured by continuous glucose monitoring)	From week 80 to week 164 of the PERL trial
Secondary	MAGE (Mean amplitude of glucose excursions)	Mean amplitude of glucose excursions as measured by continuous glucose monitoring	From week 80 to week 164 of the PERL trial
Secondary	LBGI (Low blood glucose index)	Low blood glucose index based on blood glucose values measured by continuous glucose monitoring	From week 80 to week 164 of the PERL trial
Secondary	HBGI (High blood glucose index)	High blood glucose index based on blood glucose values measured by continuous glucose monitoring	From week 80 to week 164 of the PERL trial