HbA1cNCT04125160
Glycaemic Markers in Persons With Type 2 Diabetes on Peritoneal Dialysis
An observational study of HbA1c and Peritoneal Diseases, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.
Trial summary
The aim is to investigate the correlation between mean glucose measured by continuous glucose monitoring (CGM) and mean glucose estimated from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes undergoing peritoneal dialysis compared with patients with type 2 diabetes and normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HbA1c, Peritoneal Diseases, Glycated Albumin
- What is being tested?
- Continuous glucose monitoring and Glycaemic markers
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 5 sitesDenmark
- Study dates
- 12 Nov 2019to 3 Sep 2020
- 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 90 years
- All sexes
- Adult, Older adult
Study population: Total of 52 participants with 26 in each group. Case group: 26 patients on peritoneal dialysis with type 2 diabetes. Control group: 26 patients with type 2 diabetes and normal renal function (defined as eGFR >60 ml/min and with Urine Albumin-to-Creatinine Ratio below 300mg/g. The patients are recruited from the department of Endocrinology or Nephrology at Rigshospitalet, from Herlev Hospital department of Nephrology, Steno Diabetes Center Copenhagen, Hillerød Hospital department of Nephrology and Roskilde Hospital department of Nephrology.
Inclusion criteria for case group (on peritoneal dialysis with type 2 diabetes):
- Type 2 diabetes*
- BMI 17.5-50 kg/m2
- Receiving antidiabetic treatment
- Peritoneal dialysis treatment for a minimum of 3 months
Exclusion criteria for case group (on peritoneal dialysis with type 2 diabetes):
- Type 1 diabetes
- Acute or chronic pancreatitis
- Intermittent treatment with steroid during study period (defined as more than two days)
- Haemoglobin < 5.5 mmol / l
- Hypertriglyceridemia (≥ 10mmol / L)
- Hyperbilirubinemia (≥ 35 μmol / L)
- Pregnant or breast-feeding
- Blood transfusion within the last 3 months
- Blood transfusion during the investigation period
- Splenectomy
- High alcohol consumption (defined as more than 21 units per week)
- Vitamin E supplement
- Ribavirin treatment
- Interferon Alpha treatment
- Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)
- Severe infections
Inclusion criteria for control group (type 2 diabetes and normal renal function):
- Type 2 diabetes*
- BMI 17.5-50 kg / m2
- Receiving antidiabetic treatment
- eGFR > 60 ml/min/1.73m2
- Urine Albumin-to-Creatinine Ratio < 300mg/g
Exclusion criteria for control group (type 2 diabetes and normal renal function):
- Type 1 diabetes
- Acute or chronic pancreatitis
- Intermittent treatment with steroid during study period
- Haemoglobin <7.3 mmol / l for women
- Haemoglobin <8.3 mmol / l for men
- Hypertriglyceridemia (≥ 10mmol / L)
- Hyperbilirubinemia (≥ 35 μmol / L)
- Pregnant or breast-feeding
- Blood transfusion within the last 3 months
- Blood transfusion during the investigation period
- Splenectomy
- High alcohol consumption (defined as more than 21 units per week)
- Vitamin E supplement
- Ribavirin
- Interferon Alpha treatment
- Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)
- Severe infections *Inclusion with diagnosis of type 2 diabetes was defined as ongoing antidiabetic treatment and previously diagnosed with type 2 diabetes according to the following criteria:
- A random venous plasma glucose concentration ≥ 11.1 mmol/l or
- A fasting plasma glucose concentration ≥ 7.0 mmol/l (whole blood ≥ 6.1 mmol/l) or
- Two hour plasma glucose concentration ≥ 11.1 mmol/l two hours after 75g anhydrous glucose in an oral glucose tolerance test or
- HbA1c above 48 mmol/mol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Herlev Hospital
Copenhagen, 2100
Rigshospitalet department of endocrinology
Copenhagen
Hillerød Hospital
Hillerød, 3400
Rigshospitalet department of nephrology
København Ø, 2100
Roskilde Hospital
Roskilde
About this study
Official title: Markers for Glycaemic Control and Continuous Glucose Monitoring in Persons With Type 2 Diabetes on Peritoneal Dialysis
The aim is to investigate the correlation between mean glucose measured by continuous glucose monitoring (CGM) and mean glucose estimated from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes undergoing peritoneal dialysis compared with patients with type 2 diabetes and normal renal function. Furthermore, the aim is to compare CGM and HbA1c with glycated albumin and fructosamine.
Read the detailed description
Background:
In persons with type 2 diabetes, glycated haemoglobin A1c (HbA1c) is used as an indirect measure of the mean glucose over the past 3-4 months. The normal range of HbA1c and the correlation to the mean glucose has been determined from studies in subjects without severe chronic kidney disease.
In persons with end-stage renal disease (ESRD) and type 2 diabetes, HbA1c has been shown in small studies to underestimate mean glucose when compared with continuous glucose monitoring (CGM) or alternative glycaemic markers such as glycated albumin or fructosamine. The cause of a falsely low HbA1c in persons with ESRD and diabetes is not clear, but adjuvant erythropoietin treatment and iron infusion increase erythropoiesis, thus increasing the number of new non-glycated erythrocytes that are thought to lower HbA1c. Furthermore, the erythrocyte life span was found to be decreased in individuals receiving hemodialysis and peritoneal dialysis, which may also contribute to a reduction in HbA1c.
CGM is an alternative to HbA1c in glycaemic monitoring and measures interstitial glucose that calibrates with blood glucose within minutes. CGM measures interstitial glucose every five minutes for up to eight days (Medtronic's Ipro2). Studies of persons with type 1 diabetes and CGM measurements performed over three months showed that approximately two-weeks of CGM measurements correlated to HbA1c. When CGM was performed beyond 14 days, the correlation between the mean glucose from CGM and HbA1c improved only modestly.
Values of CGM measurements also provide a basis for monitoring glycaemic variability, time-in-range and hypoglycaemic episodes. For persons with diabetes undergoing peritoneal dialysis, there are only a few studies validating HbA1c and none have been prospective with a control group over a long period of time. A retrospective study of 60 persons with diabetes and in peritoneal dialysis (without control group) found a significant correlation between HbA1c and mean interstitial glucose as measured by CGM (r = 0.48, P≤0.0001). A prospective study of 25 persons with diabetes and in peritoneal dialysis (without control group) also found a significant correlation (r = 0.51, P≤0.01). A study of three persons with diabetes and in peritoneal dialysis (without control group) found that HbA1c compared to CGM underestimated mean glucose in one, but overestimated mean glucose in the other two. However, all three studies did not include a control group and had few days of CGM measurements, which collectively mean that the evidence for the use of HbA1c in this patient group is sparse.
In a study of peritoneal dialysis subjects with diabetic nephropathy (n = 1296), 17.7% had normal HbA1c and were without antidiabetic treatment. When the same study included glycated albumin, 10.9% were found to have normal HbA1c, normal glycated albumin (defined as less than 16%) and were without antidiabetic medication. The study concluded that normal HbA1c alone overestimates the prevalence of burnt-out diabetes.
The uncertainty associated with HbA1c in persons with type 2 diabetes undergoing peritoneal dialysis is a problem both in terms of diagnosing and treating diabetes appropriately. CGM, glycated albumin and fructosamine are independent of erythrocyte turnover thus allowing for a validation of HbA1c in this group of patients.
Objective:
To investigate the correlation between mean glucose measured by continuous glucose monitoring (CGM) and mean glucose estimated from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes undergoing peritoneal dialysis compared with a control group of persons with type 2 diabetes and normal renal function.
Method:
Prospective case-control study over 16 days with 26 persons in each group. The case group consist of persons with type 2 diabetes undergoing peritoneal dialysis and the control group consists of persons with type 2 diabetes with normal renal function (defined as an estimated glomerular filtration rate (eGFR) above 60 ml/min and urine albumin-creatinine ratio below 300mg/g). CGM is performed for a maximum of 16 days. On visit 1 (day 0), CGM is performed for 8 days and visit 2 (day 8) (+7/-4 days), CGM is performed for another 8 days. Glycaemic markers are measured at baseline and on visit 3 (final day of the study). At least 12 days of CGM must be completed for each person. Data is collected using REDcap.
Statistics:
The null hypothesis is that there is no difference in the ratio between the two groups measured as mean glucose concentration measured over 16 days at CGM (mmol / L) divided by the estimated glucose concentration from HbA1c (mmol / L) measured at day 16.
The alternative hypothesis is that there is a 17% difference between groups for the ratio of mean glucose concentration measured by CGM (mmol / L) divided by the mean glucose concentration from HbA1c (mmol / L). In a pilot study of persons with type 2 diabetes and dialysis dependent ESRD compared with persons with normal renal function, a 17% difference was found in the ratio between the two groups. In a two-sided unpaired t-test with α = 0.05, SD = 1.17 and power of 90%, a sample size of 24 individuals in each group will show a significant difference. A drop of approximately 10% is expected and a total of 26 are included in each group.
- Being tested
- Continuous glucose monitoring, Glycaemic markers
- Medical subject headings
- Peritoneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Continuous glucose monitoring over 16 days
Glycaemic markersDiagnostic test
Measurement of HbA1c, glycated albumin and fructosamine.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes and peritoneal dialysis | Case group with type 2 diabetes undergoing peritoneal dialysis for at least 3 months. Receives: Device: Continuous glucose monitoring; Diagnostic Test: Glycaemic markers | |
| Type 2 diabetes and eGFR above 60ml/min | Control group with type 2 diabetes and no nephropathy (defined as eGFR above 60ml/min and UACR below 300mg/g). Receives: Device: Continuous glucose monitoring; Diagnostic Test: Glycaemic markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c evaluated by the total mean glucose from continuous glucose monitoring
Difference between the two groups in the ratio of mean glucose measured by continuous glucose monitoring (measured over 16 days) divided by the estimated mean blood glucose from HbA1c (measured at the final visit). For each person at least 12 days of CGM must be completed.
Measured: 16 days
Secondary outcomes (11)
Glycated albumin
Correlation between mean glucose from continuous glucose monitoring (measured over 16 days) and glycated albumin ((%) measured at the final visit).
Measured: 16 days
Fructosamine
Correlation between mean glucose from continuous glucose monitoring (measured over 16 days) and fructosamine ((μmol/l) measured at the final visit).
Measured: 16 days
Standard deviation
Standard deviation for glycaemic variability measured by continuous glucose monitoring in both groups.
Measured: 16 days
Coefficient variation
Coefficient variation for glycaemic variability measured by continuous glucose monitoring in both groups.
Measured: 16 days
Low Blood Glucose Index
Low Blood Glucose Index for glycaemic variability measured by continuous glucose monitoring in both groups. Is a risk index for predicting hypoglycaemia.
Measured: 16 days
High Blood Glucose Index
High Blood Glucose Index for glycaemic variability measured by continuous glucose monitoring in both groups. Is a risk index for predicting hyperglycaemia.
Measured: 16 days
Time in hypoglycaemic range below 3.0 mmol/l
Time in hypoglycaemic range(%) below 3.0 mmol/l evaluated by continuous glucose monitoring .
Measured: 16 days
Time in hypoglycaemic range below 3.9 mmol/l to 3.0 mmol/l
Time in hypoglycaemic range(%) below 3.9 mmol/l to 3.0 mmol/l evaluated by continuous glucose monitoring .
Measured: 16 days
Time in hyperglycaemic range above 10.0 mmol/l
Time in hyperglycaemic range(%) above 10.0 mmol/l evaluated by continuous glucose monitoring .
Measured: 16 days
Time in hyperglycaemic range above 13.9 mmol/l
Time in hyperglycaemic range(%) above 13.9 mmol/l evaluated by continuous glucose monitoring
Measured: 16 days
Hypoglycaemic events
Beginning of a CGM event is defined as a reading below the threshold for at least 15 min for either a value below 3.0 mmol/l or between 3.9 mmol/l to 3.0 mmol/l. The end of a CGM event is defined as a reading for 15 min above 3.9 mmol/l.
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start12 Nov 2019
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HbA1cStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Zealand University Hospital, Herlev Hospital, Hillerod Hospital, Denmark
- Responsible party
- Principal investigator, Bo Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125160
- Sponsor's protocol ID
- GLYCO-PD
- Status last verified
- Sep 2020
- First submitted
- 10 Oct 2019
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers for Glycaemic Control and Continuous Glucose Monitoring in Persons With Type 2 Diabetes on Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT04125160
- Acronym / sponsor ID
- GLYCO-PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Zealand University Hospital, Herlev Hospital, Hillerod Hospital, Denmark
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 14 Oct 2019 (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.
The aim is to investigate the correlation between mean glucose measured by continuous glucose monitoring (CGM) and mean glucose estimated from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes undergoing peritoneal dialysis compared with patients with type 2 diabetes and normal renal function. Furthermore, the aim is to compare CGM and HbA1c with glycated albumin and fructosamine.
Detailed description
Background:
In persons with type 2 diabetes, glycated haemoglobin A1c (HbA1c) is used as an indirect measure of the mean glucose over the past 3-4 months. The normal range of HbA1c and the correlation to the mean glucose has been determined from studies in subjects without severe chronic kidney disease.
In persons with end-stage renal disease (ESRD) and type 2 diabetes, HbA1c has been shown in small studies to underestimate mean glucose when compared with continuous glucose monitoring (CGM) or alternative glycaemic markers such as glycated albumin or fructosamine. The cause of a falsely low HbA1c in persons with ESRD and diabetes is not clear, but adjuvant erythropoietin treatment and iron infusion increase erythropoiesis, thus increasing the number of new non-glycated erythrocytes that are thought to lower HbA1c. Furthermore, the erythrocyte life span was found to be decreased in individuals receiving hemodialysis and peritoneal dialysis, which may also contribute to a reduction in HbA1c.
CGM is an alternative to HbA1c in glycaemic monitoring and measures interstitial glucose that calibrates with blood glucose within minutes. CGM measures interstitial glucose every five minutes for up to eight days (Medtronic's Ipro2). Studies of persons with type 1 diabetes and CGM measurements performed over three months showed that approximately two-weeks of CGM measurements correlated to HbA1c. When CGM was performed beyond 14 days, the correlation between the mean glucose from CGM and HbA1c improved only modestly.
Values of CGM measurements also provide a basis for monitoring glycaemic variability, time-in-range and hypoglycaemic episodes. For persons with diabetes undergoing peritoneal dialysis, there are only a few studies validating HbA1c and none have been prospective with a control group over a long period of time. A retrospective study of 60 persons with diabetes and in peritoneal dialysis (without control group) found a significant correlation between HbA1c and mean interstitial glucose as measured by CGM (r = 0.48, P≤0.0001). A prospective study of 25 persons with diabetes and in peritoneal dialysis (without control group) also found a significant correlation (r = 0.51, P≤0.01). A study of three persons with diabetes and in peritoneal dialysis (without control group) found that HbA1c compared to CGM underestimated mean glucose in one, but overestimated mean glucose in the other two. However, all three studies did not include a control group and had few days of CGM measurements, which collectively mean that the evidence for the use of HbA1c in this patient group is sparse.
In a study of peritoneal dialysis subjects with diabetic nephropathy (n = 1296), 17.7% had normal HbA1c and were without antidiabetic treatment. When the same study included glycated albumin, 10.9% were found to have normal HbA1c, normal glycated albumin (defined as less than 16%) and were without antidiabetic medication. The study concluded that normal HbA1c alone overestimates the prevalence of burnt-out diabetes.
The uncertainty associated with HbA1c in persons with type 2 diabetes undergoing peritoneal dialysis is a problem both in terms of diagnosing and treating diabetes appropriately. CGM, glycated albumin and fructosamine are independent of erythrocyte turnover thus allowing for a validation of HbA1c in this group of patients.
Objective:
To investigate the correlation between mean glucose measured by continuous glucose monitoring (CGM) and mean glucose estimated from glycated haemoglobin A1c (HbA1c) in persons with type 2 diabetes undergoing peritoneal dialysis compared with a control group of persons with type 2 diabetes and normal renal function.
Method:
Prospective case-control study over 16 days with 26 persons in each group. The case group consist of persons with type 2 diabetes undergoing peritoneal dialysis and the control group consists of persons with type 2 diabetes with normal renal function (defined as an estimated glomerular filtration rate (eGFR) above 60 ml/min and urine albumin-creatinine ratio below 300mg/g). CGM is performed for a maximum of 16 days. On visit 1 (day 0), CGM is performed for 8 days and visit 2 (day 8) (+7/-4 days), CGM is performed for another 8 days. Glycaemic markers are measured at baseline and on visit 3 (final day of the study). At least 12 days of CGM must be completed for each person. Data is collected using REDcap.
Statistics:
The null hypothesis is that there is no difference in the ratio between the two groups measured as mean glucose concentration measured over 16 days at CGM (mmol / L) divided by the estimated glucose concentration from HbA1c (mmol / L) measured at day 16.
The alternative hypothesis is that there is a 17% difference between groups for the ratio of mean glucose concentration measured by CGM (mmol / L) divided by the mean glucose concentration from HbA1c (mmol / L). In a pilot study of persons with type 2 diabetes and dialysis dependent ESRD compared with persons with normal renal function, a 17% difference was found in the ratio between the two groups. In a two-sided unpaired t-test with α = 0.05, SD = 1.17 and power of 90%, a sample size of 24 individuals in each group will show a significant difference. A drop of approximately 10% is expected and a total of 26 are included in each group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes and peritoneal dialysis | – | Device: Continuous glucose monitoring, Diagnostic Test: Glycaemic markersCase group with type 2 diabetes undergoing peritoneal dialysis for at least 3 months. |
| Type 2 diabetes and eGFR above 60ml/min | – | Device: Continuous glucose monitoring, Diagnostic Test: Glycaemic markersControl group with type 2 diabetes and no nephropathy (defined as eGFR above 60ml/min and UACR below 300mg/g). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Total of 52 participants with 26 in each group. Case group: 26 patients on peritoneal dialysis with type 2 diabetes. Control group: 26 patients with type 2 diabetes and normal renal function (defined as eGFR >60 ml/min and with Urine Albumin-to-Creatinine Ratio below 300mg/g. The patients are recruited from the department of Endocrinology or Nephrology at Rigshospitalet, from Herlev Hospital department of Nephrology, Steno Diabetes Center Copenhagen, Hillerød Hospital department of Nephrology and Roskilde Hospital department of Nephrology.
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 monitoringContinuous glucose monitoring over 16 days | Device | Type 2 diabetes and eGFR above 60ml/min, Type 2 diabetes and peritoneal dialysis |
| Glycaemic markersMeasurement of HbA1c, glycated albumin and fructosamine. | Diagnostic test | Type 2 diabetes and eGFR above 60ml/min, Type 2 diabetes and peritoneal dialysis |
Primary outcome
HbA1c evaluated by the total mean glucose from continuous glucose monitoring
Time frame: 16 days
Difference between the two groups in the ratio of mean glucose measured by continuous glucose monitoring (measured over 16 days) divided by the estimated mean blood glucose from HbA1c (measured at the final visit). For each person at least 12 days of CGM must be completed.
11 secondary outcomes
Glycated albumin
Time frame: 16 days
Fructosamine
Time frame: 16 days
Standard deviation
Time frame: 16 days
Coefficient variation
Time frame: 16 days
Low Blood Glucose Index
Time frame: 16 days
High Blood Glucose Index
Time frame: 16 days
Time in hypoglycaemic range below 3.0 mmol/l
Time frame: 16 days
Time in hypoglycaemic range below 3.9 mmol/l to 3.0 mmol/l
Time frame: 16 days
Time in hyperglycaemic range above 10.0 mmol/l
Time frame: 16 days
Time in hyperglycaemic range above 13.9 mmol/l
Time frame: 16 days
Hypoglycaemic events
Time frame: 16 days
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 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HbA1c and Peritoneal Diseases, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
HbA1c evaluated by the total mean glucose from continuous glucose monitoring (time frame: 16 days). 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 Sep 2020.