Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 7:53 AM
Study NCT ID:
NCT04125160
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2019-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic Markers in Persons With Type 2 Diabetes on Peritoneal Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2019-10-10', 'studyFirstSubmitQcDate': '2019-10-10', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c evaluated by the total mean glucose from continuous glucose monitoring', 'timeFrame': '16 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Glycated albumin', 'timeFrame': '16 days', 'description': 'Correlation between mean glucose from continuous glucose monitoring (measured over 16 days) and glycated albumin ((%) measured at the final visit).'}, {'measure': 'Fructosamine', 'timeFrame': '16 days', 'description': 'Correlation between mean glucose from continuous glucose monitoring (measured over 16 days) and fructosamine ((μmol/l) measured at the final visit).'}, {'measure': 'Standard deviation', 'timeFrame': '16 days', 'description': 'Standard deviation for glycaemic variability measured by continuous glucose monitoring in both groups.'}, {'measure': 'Coefficient variation', 'timeFrame': '16 days', 'description': 'Coefficient variation for glycaemic variability measured by continuous glucose monitoring in both groups.'}, {'measure': 'Low Blood Glucose Index', 'timeFrame': '16 days', 'description': 'Low Blood Glucose Index for glycaemic variability measured by continuous glucose monitoring in both groups. Is a risk index for predicting hypoglycaemia.'}, {'measure': 'High Blood Glucose Index', 'timeFrame': '16 days', 'description': 'High Blood Glucose Index for glycaemic variability measured by continuous glucose monitoring in both groups. Is a risk index for predicting hyperglycaemia.'}, {'measure': 'Time in hypoglycaemic range below 3.0 mmol/l', 'timeFrame': '16 days', 'description': 'Time in hypoglycaemic range(%) below 3.0 mmol/l evaluated by continuous glucose monitoring .'}, {'measure': 'Time in hypoglycaemic range below 3.9 mmol/l to 3.0 mmol/l', 'timeFrame': '16 days', 'description': 'Time in hypoglycaemic range(%) below 3.9 mmol/l to 3.0 mmol/l evaluated by continuous glucose monitoring .'}, {'measure': 'Time in hyperglycaemic range above 10.0 mmol/l', 'timeFrame': '16 days', 'description': 'Time in hyperglycaemic range(%) above 10.0 mmol/l evaluated by continuous glucose monitoring .'}, {'measure': 'Time in hyperglycaemic range above 13.9 mmol/l', 'timeFrame': '16 days', 'description': 'Time in hyperglycaemic range(%) above 13.9 mmol/l evaluated by continuous glucose monitoring'}, {'measure': 'Hypoglycaemic events', 'timeFrame': '16 days', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['HbA1c', 'Peritoneal Diseases', 'Glycated Albumin', 'Fructosamine', 'Continuous Glucose Monitoring']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Background:\n\nIn 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.\n\nIn 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.\n\nCGM 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.\n\nValues 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.\n\nIn 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.\n\nThe 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.\n\nObjective:\n\nTo 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.\n\nMethod:\n\nProspective 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.\n\nStatistics:\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Total of 52 participants with 26 in each group.\n\nCase group: 26 patients on peritoneal dialysis with type 2 diabetes.\n\nControl 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.\n\nThe 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.', 'eligibilityCriteria': 'Inclusion criteria for case group (on peritoneal dialysis with type 2 diabetes):\n\n* Type 2 diabetes\\*\n* BMI 17.5-50 kg/m2\n* Receiving antidiabetic treatment\n* Peritoneal dialysis treatment for a minimum of 3 months\n\nExclusion criteria for case group (on peritoneal dialysis with type 2 diabetes):\n\n* Type 1 diabetes\n* Acute or chronic pancreatitis\n* Intermittent treatment with steroid during study period (defined as more than two days)\n* Haemoglobin \\< 5.5 mmol / l\n* Hypertriglyceridemia (≥ 10mmol / L)\n* Hyperbilirubinemia (≥ 35 μmol / L)\n* Pregnant or breast-feeding\n* Blood transfusion within the last 3 months\n* Blood transfusion during the investigation period\n* Splenectomy\n* High alcohol consumption (defined as more than 21 units per week)\n* Vitamin E supplement\n* Ribavirin treatment\n* Interferon Alpha treatment\n* Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)\n* Severe infections\n\nInclusion criteria for control group (type 2 diabetes and normal renal function):\n\n* Type 2 diabetes\\*\n* BMI 17.5-50 kg / m2\n* Receiving antidiabetic treatment\n* eGFR \\> 60 ml/min/1.73m2\n* Urine Albumin-to-Creatinine Ratio \\< 300mg/g\n\nExclusion criteria for control group (type 2 diabetes and normal renal function):\n\n* Type 1 diabetes\n* Acute or chronic pancreatitis\n* Intermittent treatment with steroid during study period\n* Haemoglobin \\<7.3 mmol / l for women\n* Haemoglobin \\<8.3 mmol / l for men\n* Hypertriglyceridemia (≥ 10mmol / L)\n* Hyperbilirubinemia (≥ 35 μmol / L)\n* Pregnant or breast-feeding\n* Blood transfusion within the last 3 months\n* Blood transfusion during the investigation period\n* Splenectomy\n* High alcohol consumption (defined as more than 21 units per week)\n* Vitamin E supplement\n* Ribavirin\n* Interferon Alpha treatment\n* Positive for haemoglobinopathy (examined for haemoglobinopathy if patients come from Africa, Mediterranean, Middle East, Iran, Iraq, India, Pakistan or Southeast Asia)\n* Severe infections\n\n \\*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:\n* A random venous plasma glucose concentration ≥ 11.1 mmol/l or\n* A fasting plasma glucose concentration ≥ 7.0 mmol/l (whole blood ≥ 6.1 mmol/l) or\n* Two hour plasma glucose concentration ≥ 11.1 mmol/l two hours after 75g anhydrous glucose in an oral glucose tolerance test or\n* HbA1c above 48 mmol/mol'}, 'identificationModule': {'nctId': 'NCT04125160', 'briefTitle': 'Glycaemic Markers in Persons With Type 2 Diabetes on Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Markers for Glycaemic Control and Continuous Glucose Monitoring in Persons With Type 2 Diabetes on Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'GLYCO-PD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 2 diabetes and peritoneal dialysis', 'description': 'Case group with type 2 diabetes undergoing peritoneal dialysis for at least 3 months.', 'interventionNames': ['Device: Continuous glucose monitoring', 'Diagnostic Test: Glycaemic markers']}, {'label': 'Type 2 diabetes and eGFR above 60ml/min', 'description': 'Control group with type 2 diabetes and no nephropathy (defined as eGFR above 60ml/min and UACR below 300mg/g).', 'interventionNames': ['Device: Continuous glucose monitoring', 'Diagnostic Test: Glycaemic markers']}], 'interventions': [{'name': 'Continuous glucose monitoring', 'type': 'DEVICE', 'description': 'Continuous glucose monitoring over 16 days', 'armGroupLabels': ['Type 2 diabetes and eGFR above 60ml/min', 'Type 2 diabetes and peritoneal dialysis']}, {'name': 'Glycaemic markers', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of HbA1c, glycated albumin and fructosamine.', 'armGroupLabels': ['Type 2 diabetes and eGFR above 60ml/min', 'Type 2 diabetes and peritoneal dialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet department of endocrinology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Hillerød Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '2100', 'city': 'København Ø', 'country': 'Denmark', 'facility': 'Rigshospitalet department of nephrology', 'geoPoint': {'lat': 55.70968, 'lon': 12.56862}}, {'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Roskilde Hospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, {'name': 'Zealand University Hospital', 'class': 'OTHER'}, {'name': 'Herlev Hospital', 'class': 'OTHER'}, {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, DMSc, Head of Nephrology', 'investigatorFullName': 'Bo Feldt-Rasmussen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}