End Stage Kidney DiseaseNCT05741489
Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
A study testing Continuous glucose monitoring (CGM) in people with End Stage Kidney Disease, run by Emory University at 4 sites in United States.
Trial summary
Twenty participants with end stage kidney disease (ESKD) and burnt-out diabetes, and 20 non-diabetic participants with ESKD will wear a continuous glucose monitoring (CGM) device for 10 days to see if the use of CGM is a better tool to assess glycemic control than glycosylated hemoglobin (HbA1c) in patients with ESKD… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease
- What is being tested?
- Continuous glucose monitoring (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Aug 2022to 9 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis treatment for more than 3 months
- HbA1c less than 6.5% at the first clinic visit
- Willing to wear a CGM for 10 days
Who cannot join
- Have used insulin or any diabetes treatment during the last 3 months
- Be pregnant or plan to become pregnant during the study
- Known allergy to medical-grade adhesives
- Taking acetaminophen (more than 1 gram every six hours) or hydroxyurea (may interfere with sensor membrane)
- Current or anticipated use of stress steroid doses (prednisone </= 5 mg or its equivalent is allowed)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory Dialysis at Northside
Atlanta, Georgia, 30318
Emory Dialysis at Greenbriar
Atlanta, Georgia, 30331
Emory Dialysis at Candler
Decatur, Georgia, 30034
About this study
Twenty participants with end stage kidney disease (ESKD) and burnt-out diabetes, and 20 non-diabetic participants with ESKD will wear a continuous glucose monitoring (CGM) device for 10 days to see if the use of CGM is a better tool to assess glycemic control than glycosylated hemoglobin (HbA1c) in patients with ESKD on dialysis.
Read the detailed description
More than 37 million adults, or 14.7% of all Americans aged 18 and older, are living with diabetes. Controlling hyperglycemia is foundational to diabetes management and is necessary to reduce the risks of chronic diabetes complications and death. Diabetic nephropathy accounts for great morbidity, as diabetes is the number one cause of chronic kidney disease (CKD) and end stage kidney disease (ESKD) in the United States. It is estimated that diabetes affects up to 40% of patients with ESKD.
Assessment of glucose control in patients with advanced CKD/ESKD is complex due to changes in glucose homeostasis, potential effects on assays of glycemia, and altered pharmacokinetics of diabetes medications. Glycosylated hemoglobin (HbA1c) has been the gold standard to assess glycemic control in patients with diabetes. HbA1c reflects the average glycemic value over approximately 3 months. Although HbA1c is associated with chronic complications of diabetes in patients with normal kidney function, its predictive value is uncertain in patients with ESKD or estimated glomerular filtration rate (eGFR) <30 ml/min. HbA1c reliability in ESKD is reduced because of anemia, shortened erythrocyte lifespan, protein-energy wasting, and malnutrition-inflammation cachexia syndrome, among others. To overcome the limitations of HbA1c, alternative methods to assess long-term glycemic control have been proposed including fructosamine and glycated albumin. Fructosamine measures ketoamines formed by non-enzymatic glycation of serum proteins. It is a useful index for glycemic control over the prior 2 to 4 weeks, and some studies have reported that fructosamine more accurately reflects blood glucose control than HbA1c in anemic patients with ESKD on dialysis. However, there may be falsely low readings in the presence of hypoalbuminemia due to protein-energy wasting and in peritoneal dialysis due to dialysate protein loss. Glycated albumin is a useful marker reflecting glycemic control over the prior 2 to 4 weeks. In patients with ESKD, glycated albumin more rapidly reflects the status of blood glucose control than HbA1c. Like fructosamine, there is potential for falsely low readings in patients with peritoneal dialysis with dialysate protein losses and hypoalbuminemia.
Continuous glucose monitoring (CGM) technology in the outpatient setting has transformed glucose monitoring for diabetes self-management, providing more comprehensive glycemic control data than intermittent point-of-care capillary blood glucose monitoring and HbA1c.
Once progressed to ESKD, up to one fourth of patients experience resolution of their hyperglycemia, as defined by an HbA1c level of less than 6.5%, and consequently are no longer on antidiabetic agents and insulin. This phenomenon is known as "burnt-out diabetes" which is likely due to various underlying factors, including but not limited to, malnutrition, reduced clearance and degradation of insulin, decreased kidney gluconeogenesis, and accumulation of uremic toxins. These patients are likely at a greater risk of morbidity and mortality and an increased risk of hypoglycemic episodes. There is a need for further research in patients with ESKD to establish what is the most appropriate tool to assess glycemic control in those with 'burnt-out diabetes'.
This study will use CGM to measure patients' glucose with real-time levels as opposed to relying on surrogate markers like HbA1c. These results can give insight into the reality of glycemic control in these patients and can impact the best monitoring and treatment for patients with burnt-out diabetes. It is not known if patients with burnt-out diabetes have complete normoglycemia or if they may have episodes of (untreated) hyperglycemia, which may be associated with poor outcomes. The researchers of this study will compare glycemic control by CGM in patients with burnt-out diabetes and non-diabetic patients with ESKD.
- Conditions
- End Stage Kidney Disease
- Being tested
- Continuous glucose monitoring (CGM)
- Keywords
- Burnt-out diabetes, Dialysis, End stage renal disease, Kidney failure
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring (CGM)Device
Also called Dexcom G6 CGM
The Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants will wear the CGM with the display off for 10 days while continuing their routine dialysis sessions.
| Study group | Role | What they receive |
|---|---|---|
| ESKD with Burnt-out Diabetes | Experimental | Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. Receives: Device: Continuous glucose monitoring (CGM) |
| ESKD without Diabetes | Experimental | Non-diabetic participants with ESKD wearing a CGM for 10 days. Receives: Device: Continuous glucose monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Time in Range (TIR) Between 70-180 mg/dL
Glycemic control is measured as the percentage of time that blood glucose levels are in the range of 70 and 180 mg/dL, as measured by CGM.
Measured: Up to 10 days
Percent of Time Above Range (Blood Glucose >180 mg/dL)
Glycemic control is assessed a the percentage of time in hyperglycemia, defined as the time above range (TAR) with blood glucose measurements >180 mg/dL, as measured by CGM.
Measured: Up to 10 days
Percent of Time Above Range (Blood Glucose >250 mg/dL)
Glycemic control is assessed a the percentage of time in hyperglycemia, defined as the time above range (TAR) with blood glucose measurements >250 mg/dL, as measured by CGM.
Measured: Up to 10 days
Duration of Hyperglycemia (Blood Glucose >180 mg/dL)
Glycemic control is assessed as the duration of hyperglycemia with blood glucose measurements >180 mg/dL, as measured by CGM for hyperglycemia time periods of greater than 15 minutes.
Measured: Up to 10 days
Duration of Hyperglycemia (Blood Glucose >250 mg/dL)
Glycemic control is assessed as the duration of hyperglycemia with blood glucose measurements >250 mg/dL, as measured by CGM for hyperglycemia time periods of greater than 15 minutes.
Measured: Up to 10 days
Number of Participants With Hyperglycemic Episodes With Blood Glucose >250 mg/dL
The number of participants experiencing hyperglycemia with blood glucose levels > 250 mg/dL as measured by CGM.
Measured: Up to Day 10
Percent of Time Below Range (Blood Glucose <70 mg/dL)
Glycemic control is assessed a the percentage of time in hypoglycemia, defined as the time below range (TBR) with blood glucose measurements < 70 mg/dL, as measured by CGM.
Measured: Up to 10 days
Percent of Time Below Range (Blood Glucose <54 mg/dL)
Glycemic control is assessed a the percentage of time in severe hypoglycemia, defined as the time below range (TBR) with blood glucose measurements < 54 mg/dL, as measured by CGM.
Measured: Up to 10 days
Hypoglycemia Event Rate
Hypoglycemia is defined as blood glucose < 70 mg/dL and is assessed by Dexcom G6 CGM. The hypoglycemic event rate is defined as the number of hypoglycemic events per patient per day.
Measured: Up to Day 10
Number of Participants With Hypoglycemic Episodes
The number of participants experiencing hypoglycemia with blood glucose levels < 70 mg/dL as measured by CGM.
Measured: Up to Day 10
Nocturnal Hypoglycemia Event Rate
Hypoglycemia is defined as blood glucose < 70 mg/dL and is assessed by Dexcom G6 CGM. A nocturnal hypoglycemia episode is defined as an episode occurring during the time interval of 10:00 Post Meridiem (PM) to 6:00 Ante Meridiem (AM). The hypoglycemic event rate is defined as the number of hypoglycemic events per patient per day.
Measured: Up to Day 10
Number of Participants With Nocturnal Hypoglycemic Episodes
The number of participants experiencing nocturnal hypoglycemia with blood glucose levels < 70 mg/dL as measured by CGM. A nocturnal hypoglycemia episode is defined as an episode occurring during the time interval of 10:00 Post Meridiem (PM) to 6:00 Ante Meridiem (AM).
Measured: Up to Day 10
Secondary outcomes (2)
Mean Daily Blood Glucose Concentration
Glycemic control is assessed as mean daily glucose concentration, measured by Dexcom G6 CGM.
Measured: Up to Day 10
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE)
Mean amplitude of glycemic excursions (MAGE) is the parameter for assessing glycemic variability and is calculated based on the arithmetic mean of differences between consecutive peaks and nadirs of differences greater than one standard deviation (SD) of mean glucose values. It is designated to assess major glucose swings and exclude minor ones.
Measured: Up to 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start10 Aug 2022
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741489
- Sponsor's protocol ID
- STUDY00004617
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2023
- Last updated
- 5 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaminski CY, Galindo RJ, Navarrete JE, Zabala Z, Moazzami B, Gerges A, McCoy RG, Fayfman M, Vellanki P, Idrees T, Peng L, Umpierrez GE. Assessment of Glycemic Control by Continuous Glucose Monitoring, Hemoglobin A1c, Fructosamine, and Glycated Albumin in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes. Diabetes Care. 2024 Feb 1;47(2):267-271. doi: 10.2337/dc23-1276.
PubMed 38085705
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes
- ClinicalTrials.gov ID
- NCT05741489
- Acronym / sponsor ID
- STUDY00004617
- Conditions
- End Stage Kidney Disease
- Keywords
- Burnt-out diabetes, Dialysis, End stage renal disease, Kidney failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Posted 5 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty participants with end stage kidney disease (ESKD) and burnt-out diabetes, and 20 non-diabetic participants with ESKD will wear a continuous glucose monitoring (CGM) device for 10 days to see if the use of CGM is a better tool to assess glycemic control than glycosylated hemoglobin (HbA1c) in patients with ESKD on dialysis.
Detailed description
More than 37 million adults, or 14.7% of all Americans aged 18 and older, are living with diabetes. Controlling hyperglycemia is foundational to diabetes management and is necessary to reduce the risks of chronic diabetes complications and death. Diabetic nephropathy accounts for great morbidity, as diabetes is the number one cause of chronic kidney disease (CKD) and end stage kidney disease (ESKD) in the United States. It is estimated that diabetes affects up to 40% of patients with ESKD.
Assessment of glucose control in patients with advanced CKD/ESKD is complex due to changes in glucose homeostasis, potential effects on assays of glycemia, and altered pharmacokinetics of diabetes medications. Glycosylated hemoglobin (HbA1c) has been the gold standard to assess glycemic control in patients with diabetes. HbA1c reflects the average glycemic value over approximately 3 months. Although HbA1c is associated with chronic complications of diabetes in patients with normal kidney function, its predictive value is uncertain in patients with ESKD or estimated glomerular filtration rate (eGFR) <30 ml/min. HbA1c reliability in ESKD is reduced because of anemia, shortened erythrocyte lifespan, protein-energy wasting, and malnutrition-inflammation cachexia syndrome, among others. To overcome the limitations of HbA1c, alternative methods to assess long-term glycemic control have been proposed including fructosamine and glycated albumin. Fructosamine measures ketoamines formed by non-enzymatic glycation of serum proteins. It is a useful index for glycemic control over the prior 2 to 4 weeks, and some studies have reported that fructosamine more accurately reflects blood glucose control than HbA1c in anemic patients with ESKD on dialysis. However, there may be falsely low readings in the presence of hypoalbuminemia due to protein-energy wasting and in peritoneal dialysis due to dialysate protein loss. Glycated albumin is a useful marker reflecting glycemic control over the prior 2 to 4 weeks. In patients with ESKD, glycated albumin more rapidly reflects the status of blood glucose control than HbA1c. Like fructosamine, there is potential for falsely low readings in patients with peritoneal dialysis with dialysate protein losses and hypoalbuminemia.
Continuous glucose monitoring (CGM) technology in the outpatient setting has transformed glucose monitoring for diabetes self-management, providing more comprehensive glycemic control data than intermittent point-of-care capillary blood glucose monitoring and HbA1c.
Once progressed to ESKD, up to one fourth of patients experience resolution of their hyperglycemia, as defined by an HbA1c level of less than 6.5%, and consequently are no longer on antidiabetic agents and insulin. This phenomenon is known as "burnt-out diabetes" which is likely due to various underlying factors, including but not limited to, malnutrition, reduced clearance and degradation of insulin, decreased kidney gluconeogenesis, and accumulation of uremic toxins. These patients are likely at a greater risk of morbidity and mortality and an increased risk of hypoglycemic episodes. There is a need for further research in patients with ESKD to establish what is the most appropriate tool to assess glycemic control in those with 'burnt-out diabetes'.
This study will use CGM to measure patients' glucose with real-time levels as opposed to relying on surrogate markers like HbA1c. These results can give insight into the reality of glycemic control in these patients and can impact the best monitoring and treatment for patients with burnt-out diabetes. It is not known if patients with burnt-out diabetes have complete normoglycemia or if they may have episodes of (untreated) hyperglycemia, which may be associated with poor outcomes. The researchers of this study will compare glycemic control by CGM in patients with burnt-out diabetes and non-diabetic patients with ESKD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESKD with Burnt-out Diabetes | Experimental | Device: Continuous glucose monitoring (CGM)Participants with ESKD and burnt-out diabetes wearing a CGM for 10 days. |
| ESKD without Diabetes | Experimental | Device: Continuous glucose monitoring (CGM)Non-diabetic participants with ESKD wearing a CGM for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dialysis treatment for more than 3 months
- HbA1c less than 6.5% at the first clinic visit
- Willing to wear a CGM for 10 days
Key exclusion criteria (5 listed)
- Have used insulin or any diabetes treatment during the last 3 months
- Be pregnant or plan to become pregnant during the study
- Known allergy to medical-grade adhesives
- Taking acetaminophen (more than 1 gram every six hours) or hydroxyurea (may interfere with sensor membrane)
- Current or anticipated use of stress steroid doses (prednisone </= 5 mg or its equivalent is allowed)
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 |
|---|---|---|
| Continuous glucose monitoring (CGM)Also: Dexcom G6 CGMThe Dexcom G6 CGM system is a compact, light-weight glucose testing device that measures glucose every 5 minutes. Participants will wear the CGM with the display off for 10 days while continuing their routine dialysis sessions. | Device | ESKD with Burnt-out Diabetes, ESKD without Diabetes |
Primary outcome
Percent of Time in Range (TIR) Between 70-180 mg/dL
Time frame: Up to 10 days
Glycemic control is measured as the percentage of time that blood glucose levels are in the range of 70 and 180 mg/dL, as measured by CGM.
Percent of Time Above Range (Blood Glucose >180 mg/dL)
Time frame: Up to 10 days
Glycemic control is assessed a the percentage of time in hyperglycemia, defined as the time above range (TAR) with blood glucose measurements >180 mg/dL, as measured by CGM.
Percent of Time Above Range (Blood Glucose >250 mg/dL)
Time frame: Up to 10 days
Glycemic control is assessed a the percentage of time in hyperglycemia, defined as the time above range (TAR) with blood glucose measurements >250 mg/dL, as measured by CGM.
Duration of Hyperglycemia (Blood Glucose >180 mg/dL)
Time frame: Up to 10 days
Glycemic control is assessed as the duration of hyperglycemia with blood glucose measurements >180 mg/dL, as measured by CGM for hyperglycemia time periods of greater than 15 minutes.
Duration of Hyperglycemia (Blood Glucose >250 mg/dL)
Time frame: Up to 10 days
Glycemic control is assessed as the duration of hyperglycemia with blood glucose measurements >250 mg/dL, as measured by CGM for hyperglycemia time periods of greater than 15 minutes.
Number of Participants With Hyperglycemic Episodes With Blood Glucose >250 mg/dL
Time frame: Up to Day 10
The number of participants experiencing hyperglycemia with blood glucose levels > 250 mg/dL as measured by CGM.
Percent of Time Below Range (Blood Glucose <70 mg/dL)
Time frame: Up to 10 days
Glycemic control is assessed a the percentage of time in hypoglycemia, defined as the time below range (TBR) with blood glucose measurements < 70 mg/dL, as measured by CGM.
Percent of Time Below Range (Blood Glucose <54 mg/dL)
Time frame: Up to 10 days
Glycemic control is assessed a the percentage of time in severe hypoglycemia, defined as the time below range (TBR) with blood glucose measurements < 54 mg/dL, as measured by CGM.
Hypoglycemia Event Rate
Time frame: Up to Day 10
Hypoglycemia is defined as blood glucose < 70 mg/dL and is assessed by Dexcom G6 CGM. The hypoglycemic event rate is defined as the number of hypoglycemic events per patient per day.
Number of Participants With Hypoglycemic Episodes
Time frame: Up to Day 10
The number of participants experiencing hypoglycemia with blood glucose levels < 70 mg/dL as measured by CGM.
Nocturnal Hypoglycemia Event Rate
Time frame: Up to Day 10
Hypoglycemia is defined as blood glucose < 70 mg/dL and is assessed by Dexcom G6 CGM. A nocturnal hypoglycemia episode is defined as an episode occurring during the time interval of 10:00 Post Meridiem (PM) to 6:00 Ante Meridiem (AM). The hypoglycemic event rate is defined as the number of hypoglycemic events per patient per day.
Number of Participants With Nocturnal Hypoglycemic Episodes
Time frame: Up to Day 10
The number of participants experiencing nocturnal hypoglycemia with blood glucose levels < 70 mg/dL as measured by CGM. A nocturnal hypoglycemia episode is defined as an episode occurring during the time interval of 10:00 Post Meridiem (PM) to 6:00 Ante Meridiem (AM).
2 secondary outcomes
Mean Daily Blood Glucose Concentration
Time frame: Up to Day 10
Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: Up to 10 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38085705Kaminski CY, Galindo RJ, Navarrete JE, Zabala Z, Moazzami B, Gerges A, McCoy RG, Fayfman M, Vellanki P, Idrees T, Peng L, Umpierrez GE. Assessment of Glycemic Control by Continuous Glucose Monitoring, Hemoglobin A1c, Fructosamine, and Glycated Albumin in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes. Diabetes Care. 2024 Feb 1;47(2):267-271. doi: 10.2337/dc23-1276.
- 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.
Guillermo Umpierrez, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring (CGM) in people with End Stage Kidney Disease, run by Emory University at 4 sites in United States.
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 3 inclusion and 5 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Time in Range (TIR) Between 70-180 mg/dL (time frame: Up to 10 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741489, which also lists 1 linked publication.
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 5 Apr 2024.