Diabetic NephropathiesNCT03334318
PERL Continuous Glucose Monitoring (CGM) Study
An observational study of Diabetic Nephropathies, run by Joslin Diabetes Center at 19 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Mean blood glucose, Blood glucose CV and % time 70-180 mg/dL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 1 Oct 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants of the PERL Clinical Trial
Who may be able to join
- Being an active participant in the PERL clinical trial
Who cannot join
- Having completed PERL Visit 16
- Pregnancy
- History of skin reactions in relation to the application of Abbott Freestyle Libre Pro
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites
Brehm Center for Diabetes Research / University of Michigan
Ann Arbor, Michigan, 48105
Emory University - Grady Memorial Hospital
Atlanta, Georgia, 30303
Barbara Davis Center / University of Colorado Denver
Aurora, Colorado, 80045
Joslin Diabetes Center
Boston, Massachusetts, 02215
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
UT Southwestern Dallas
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
University of Minnesota
Minneapolis, Minnesota, 55455
ICAHN School of Medicine at Mount Sinai
New York, New York, 10029
Virginia Mason Medical Center
Seattle, Washington, 98101
University of Washington
Seattle, Washington, 98105
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Washington University
St Louis, Missouri, 63110
SUNY Upstate Medical University
Syracuse, New York, 13210
Albert Einstein College of Medicine / Montefiore Medical Center
The Bronx, New York, 10461
Canada4 sites
Unversity of Calgary
Calgary, Alberta, T2T 5C7
University of Alberta
Edmonton, Alberta, T6G2E1
University of Toronto
Toronto, Ontario, M5T-3L9
BC Diabetes
Vancouver, British Columbia, V5Y 3W2
About this study
Official title: 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.
Read the 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
- 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).
- 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.
- To assess the relationship between CGM-measured glycemic parameters and HbA1c at various levels of renal function.
- To compare the effects of CGM metrics on the PERL renal endpoint and the corresponding effect of HbA1c.
- 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
- Being tested
- Mean blood glucose, Blood glucose CV, % time 70-180 mg/dL, % time below 54 mg/dL, % time above 180 mg/dL
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mean blood glucoseOther
Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
Blood glucose CVOther
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/dLOther
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/dLOther
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/dLOther
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/dLOther
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)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)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)Other
High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
AllopurinolDrug
Oral allopurinol tablets administered in the PERL Clinical Trial
PlaceboDrug
Oral placebo tablets administered in the PERL Clinical Trial
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol-treated | Participants in the PERL Clinical Trial (NCT02017171) randomized to allopurinol Receives: 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; Other: % time above 250 mg/dL; Other: 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 Receives: 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; Other: % time above 250 mg/dL; Other: MAGE (Mean amplitude of glucose excursions); Other: LBGI (Low Blood Glucose Index); Other: HBGI (High Blood Glucose Index); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 164 of the PERL trial
Secondary outcomes (16)
HbA1c at week 80 of the PERL trial
Hba1c value at week 80 of the PERL trial
Measured: Week 80 of the PERL Trial
HbA1c at week 96 of the PERL trial
Hba1c value at week 96 of the PERL trial
Measured: Week 96 of the PERL Trial
HbA1c at week 112 of the PERL trial
Hba1c value at week 112 of the PERL trial
Measured: Week 112 of the PERL Trial
HbA1c at week 128 of the PERL trial
Hba1c value at week 128 of the PERL trial
Measured: Week 128 of the PERL Trial
HbA1c at week 142 of the PERL trial
Hba1c value at week 142 of the PERL trial
Measured: Week 142 of the PERL Trial
HbA1c at week 156 of the PERL trial
Hba1c value at week 156 of the PERL trial
Measured: Week 156 of the PERL Trial
HbA1c at week 164 of the PERL trial
Hba1c value at week 164 of the PERL trial
Measured: Week 164 of the PERL Trial
Mean blood glucose
Mean of blood glucose values measured by continuous glucose monitoring
Measured: From week 80 to week 164 of the PERL trial
CV (coefficient of variation) of blood glucose
Coefficient of variation of blood glucose values measured by continuous glucose monitoring
Measured: From week 80 to week 164 of the PERL trial
% time 70-180 mg/dL
Percentage of time with blood glucose in the 70-180 mg/dL range (as measured by continuous glucose monitoring)
Measured: From week 80 to week 164 of the PERL trial
% time below 54 mg/dL
Percentage of time with blood glucose below 54 mg/dL (as measured by continuous glucose monitoring)
Measured: From week 80 to week 164 of the PERL trial
% time above 180 mg/dL
Percentage of time with blood glucose above 180 mg/dL (as measured by continuous glucose monitoring)
Measured: From week 80 to week 164 of the PERL trial
% time above 250 mg/dL
Percentage of time with blood glucose above 250 mg/dL (as measured by continuous glucose monitoring)
Measured: 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
Measured: From week 80 to week 164 of the PERL trial
LBGI (Low blood glucose index)
Low blood glucose index based on blood glucose values measured by continuous glucose monitoring
Measured: From week 80 to week 164 of the PERL trial
HBGI (High blood glucose index)
High blood glucose index based on blood glucose values measured by continuous glucose monitoring
Measured: From week 80 to week 164 of the PERL trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Oct 2017
- Primary completion31 Aug 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, University of Minnesota, University of Colorado, Denver, University of Michigan, Northwestern University, Albert Einstein College of Medicine, Washington University School of Medicine, University of Washington, Providence Medical Research Center
- Responsible party
- Principal investigator, Alessandro Doria, Joslin Diabetes Center
- Investigators
- Alessandro Doria, MD PhD MPH, Principal investigator, Joslin Diabetes CenterIrl Hirsch, MD, Principal investigator, University of WashingtonJanet McGill, MD, Principal investigator, Washington University, St. Louis, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334318
- Sponsor's protocol ID
- 2018PG-T1D014
- Status last verified
- Mar 2022
- First submitted
- 23 Oct 2017
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERL (Preventing Early Renal Loss in Diabetes) Continuous Glucose Monitoring (CGM) Study
- ClinicalTrials.gov ID
- NCT03334318
- Acronym / sponsor ID
- 2018PG-T1D014
- Conditions
- Diabetic Nephropathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, University of Minnesota, University of Colorado, Denver, University of Michigan, Northwestern University, Albert Einstein College of Medicine, Washington University School of Medicine, University of Washington, Providence Medical Research Center
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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).
- 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.
- To assess the relationship between CGM-measured glycemic parameters and HbA1c at various levels of renal function.
- To compare the effects of CGM metrics on the PERL renal endpoint and the corresponding effect of HbA1c.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol-treated | – | 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, Other: % time above 250 mg/dL, Other: MAGE (Mean amplitude of glucose excursions), Other: LBGI (Low Blood Glucose Index), Other: HBGI (High Blood Glucose Index), Drug: AllopurinolParticipants in the PERL Clinical Trial (NCT02017171) randomized to allopurinol |
| Placebo-treated | – | 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, Other: % time above 250 mg/dL, Other: MAGE (Mean amplitude of glucose excursions), Other: LBGI (Low Blood Glucose Index), Other: HBGI (High Blood Glucose Index), Drug: PlaceboParticipants in the PERL Clinical Trial (NCT02017171) randomized to placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the PERL Clinical Trial
Key inclusion criteria (1 listed)
- Being an active participant in the PERL clinical trial
Key exclusion criteria (3 listed)
- Having completed PERL Visit 16
- Pregnancy
- History of skin reactions in relation to the application of Abbott Freestyle Libre Pro
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mean blood glucoseMean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial. | Other | Allopurinol-treated, Placebo-treated |
| Blood glucose CVCoefficient of variation of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial. | Other | Allopurinol-treated, Placebo-treated |
| % time 70-180 mg/dLPercent 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. | Other | Allopurinol-treated, Placebo-treated |
| % time below 54 mg/dLPercent 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. | Other | Allopurinol-treated, Placebo-treated |
| % time above 180 mg/dLPercent 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. | Other | Allopurinol-treated, Placebo-treated |
| % time above 250 mg/dLPercent 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. | Other | Allopurinol-treated, Placebo-treated |
| 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. | Other | Allopurinol-treated, Placebo-treated |
| 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. | Other | Allopurinol-treated, Placebo-treated |
| 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. | Other | Allopurinol-treated, Placebo-treated |
| AllopurinolOral allopurinol tablets administered in the PERL Clinical Trial | Drug | Allopurinol-treated |
| PlaceboOral placebo tablets administered in the PERL Clinical Trial | Drug | Placebo-treated |
Primary outcome
iGFR at the end of the PERL trial
Time frame: Week 164 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.
16 secondary outcomes
HbA1c at week 80 of the PERL trial
Time frame: Week 80 of the PERL Trial
HbA1c at week 96 of the PERL trial
Time frame: Week 96 of the PERL Trial
HbA1c at week 112 of the PERL trial
Time frame: Week 112 of the PERL Trial
HbA1c at week 128 of the PERL trial
Time frame: Week 128 of the PERL Trial
HbA1c at week 142 of the PERL trial
Time frame: Week 142 of the PERL Trial
HbA1c at week 156 of the PERL trial
Time frame: Week 156 of the PERL Trial
HbA1c at week 164 of the PERL trial
Time frame: Week 164 of the PERL Trial
Mean blood glucose
Time frame: From week 80 to week 164 of the PERL trial
CV (coefficient of variation) of blood glucose
Time frame: From week 80 to week 164 of the PERL trial
% time 70-180 mg/dL
Time frame: From week 80 to week 164 of the PERL trial
% time below 54 mg/dL
Time frame: From week 80 to week 164 of the PERL trial
% time above 180 mg/dL
Time frame: From week 80 to week 164 of the PERL trial
% time above 250 mg/dL
Time frame: From week 80 to week 164 of the PERL trial
MAGE (Mean amplitude of glucose excursions)
Time frame: From week 80 to week 164 of the PERL trial
LBGI (Low blood glucose index)
Time frame: From week 80 to week 164 of the PERL trial
HBGI (High blood glucose index)
Time frame: From week 80 to week 164 of the PERL trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Doria, MD PhD MPH principal investigator
Joslin Diabetes Center
Irl Hirsch, MD principal investigator
University of Washington
Janet McGill, MD principal investigator
Washington University, St. Louis, MO
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies, run by Joslin Diabetes Center at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iGFR at the end of the PERL trial (time frame: Week 164 of the PERL trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.