PERL Continuous Glucose Monitoring (CGM) Study

NCT ID: NCT03334318

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 175 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-12-31

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.

Detailed 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.

Conditions

Diabetic Nephropathies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Allopurinol-treated

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

Mean blood glucose

Intervention Type: OTHER

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

Blood glucose CV

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Allopurinol

Intervention Type: DRUG

Oral allopurinol tablets administered in the PERL Clinical Trial

Placebo-treated

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

Mean blood glucose

Intervention Type: OTHER

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

Blood glucose CV

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Placebo

Intervention Type: DRUG

Oral placebo tablets administered in the PERL Clinical Trial

Interventions

Mean blood glucose

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

% 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.

Intervention Type: OTHER

% 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.

Intervention Type: OTHER

% 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.

Intervention Type: OTHER

% 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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Allopurinol

Oral allopurinol tablets administered in the PERL Clinical Trial

Intervention Type: DRUG

Placebo

Oral placebo tablets administered in the PERL Clinical Trial

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Northwestern University Feinberg School of Medicine

OTHER

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Providence Medical Research Center

OTHER

Sponsor Role: collaborator

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Doria

Senior Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Doria, MD PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Irl Hirsch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Janet McGill, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University, St. Louis, MO

Locations

Barbara Davis Center / University of Colorado Denver

Aurora, Colorado, United States

Emory University - Grady Memorial Hospital

Atlanta, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Brehm Center for Diabetes Research / University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

ICAHN School of Medicine at Mount Sinai

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Albert Einstein College of Medicine / Montefiore Medical Center

The Bronx, New York, United States

UT Southwestern Dallas

Dallas, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Unversity of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

BC Diabetes

Vancouver, British Columbia, Canada

University of Toronto

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

2018PG-T1D014

Identifier Type: -

Identifier Source: org_study_id