Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 9:53 AM
Study NCT ID:
NCT04322435
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2019-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566130', 'term': 'Adrenal Insufficiency, Congenital'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2019-11-15', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of hypoglycaemia', 'timeFrame': '1 year', 'description': 'Number of hypoglycaemic events. Hypoglycaemia will be defined by a glucose level measured at a glucose level of less than or equal to 0.55 g /L (3 mmol /L).'}], 'secondaryOutcomes': [{'measure': 'Duration of hypoglycaemia', 'timeFrame': '1 year', 'description': 'Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.'}, {'measure': 'Percentage of time in hypoglycaemia', 'timeFrame': '1 year', 'description': 'Percentage of time in hypoglycaemia during the continuous blood glucose measurements.'}, {'measure': 'Glycemic variations rate', 'timeFrame': '1 year', 'description': 'Glycemic variations rate during the different measurements times: minimum rate, maximum rate, average, median. Each result will be expressed in g /L or in mmol /L. Each date will expressed by one day and for one week.'}, {'measure': 'Circumstances of occurrence of hypoglycaemia', 'timeFrame': '1 year', 'description': 'Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents.'}, {'measure': 'Occurrence of medical events', 'timeFrame': '1 year', 'description': 'Events during the follow-up of the study: modification of treatment of hydrocortisone and fludrocortisone, re-sugaring expressed in number of sugar cubes ( by sugar cube = 20 gr of sugar) or type of sweet food given to the child, hospitalizations ( type and reason for hospitalization, cause of the decompensation).'}, {'measure': 'Body Mass Index', 'timeFrame': '1 year', 'description': 'Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters'}, {'measure': 'Systolic and Diastolic Blood Pressure', 'timeFrame': '1 year', 'description': 'Expressed millimetre of mercury'}, {'measure': 'Heart rate', 'timeFrame': '1 year', 'description': 'Number of beats per minute'}, {'measure': 'Stade tanner', 'timeFrame': '1 year', 'description': 'stade tanner A1 to A5'}, {'measure': 'Amount of salt consumed per day', 'timeFrame': '1 year', 'description': 'Number of grams per day'}, {'measure': 'Cortisol at 8 a.m.', 'timeFrame': '1 year', 'description': 'microgram / deciliter'}, {'measure': 'Cycle of 17-hydroxyprogesterone', 'timeFrame': '1 year', 'description': 'Nanomole per liter'}, {'measure': 'Adreno CorticoTropic Hormone', 'timeFrame': '1 year', 'description': 'Nanogram per liter'}, {'measure': '17-hydroxyprogesterone', 'timeFrame': '1 year', 'description': 'Nanomole per liter'}, {'measure': 'Delta-4-Androstenedione', 'timeFrame': '1 year', 'description': 'Nanomole per liter'}, {'measure': 'Testosterone', 'timeFrame': '1 year', 'description': 'Nanomole per liter'}, {'measure': 'Ionogram', 'timeFrame': '1 year', 'description': 'Nanomole per liter'}, {'measure': 'Renin', 'timeFrame': '1 year', 'description': 'picogram/milliliter'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital primary and secondary adrenal insufficiency', 'Cortisol deficiency', 'Hypoglycaemia', 'Children'], 'conditions': ['Adrenal Insufficiency, Congenital']}, 'referencesModule': {'references': [{'pmid': '37952170', 'type': 'BACKGROUND', 'citation': 'Galderisi A, Kariyawasam D, Stoupa A, Quoc AN, Pinto G, Viaud M, Brabant S, Beltrand J, Polak M, Samara-Boustani D. Glucose pattern in children with classical congenital adrenal hyperplasia: evidence from continuous glucose monitoring. Eur J Endocrinol. 2023 Nov 8;189(5):K19-K24. doi: 10.1093/ejendo/lvad147.'}]}, 'descriptionModule': {'briefSummary': 'Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is probably underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely.\n\nThe objective of the study is to evaluate the prevalence of hypoglycaemia in children with adrenal insufficiency.', 'detailedDescription': "Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely.\n\nThe objective of the study is to evaluate the prevalence of hypoglycaemia in children with congenital adrenal insufficiency.\n\nThe study will follow for one year children from 6 months to 6 years, with central and peripheral adrenal insufficiency.\n\n4 study times are planned with two measurement methods:\n\n* Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.\n* Measurement of capillary blood glucose, in the morning on an empty stomach, every first week of each month for 12 months, with Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the test strips Accu-Chek performed.\n* Measurement of capillary glycaemia in case of suspicion of hypoglycaemia. Measure left free according to the judgment of the parents of the necessary character or not. With Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek performa strips."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All male and female patients, followed in the Paediatric Endocrinology Department at Necker Hospital, with congenital primary and secondary adrenal insufficiency.\n* Age between 6 months and 6 years.\n* Included in the social security system.\n* Parental consent and willingness to participate in this study: involves training and skills in the use of blood glucometers.\n\nExclusion Criteria:\n\n* Patients with acquired adrenal insufficiency.\n* Patients with type 1 or type 2 diabetes.\n* Patients with somatotropic deficiency associated with adrenal insufficiency.\n* Refusal or impossibility to perform the glycaemic measurements according to the procedure of the study.\n* Not covered by the social security system.'}, 'identificationModule': {'nctId': 'NCT04322435', 'acronym': 'GLYSUR', 'briefTitle': 'Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency', 'orgStudyIdInfo': {'id': 'APHP190910'}, 'secondaryIdInfos': [{'id': 'ID RCB 2019-A02250-57', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Adrenal insufficiency', 'description': 'Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.', 'interventionNames': ['Other: Continuous blood glucose measurement', 'Other: Measurement of capillary blood glucose']}], 'interventions': [{'name': 'Continuous blood glucose measurement', 'type': 'OTHER', 'description': 'Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.', 'armGroupLabels': ['Adrenal insufficiency']}, {'name': 'Measurement of capillary blood glucose', 'type': 'OTHER', 'description': "Measurement of capillary blood glucose :\n\n* In the morning on an empty stomach, every first week of each month for 12 months.\n* In case of suspicion of hypoglycaemia (parental assessment). Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek Performa strips.", 'armGroupLabels': ['Adrenal insufficiency']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Dinane Samara-Boustani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Michel Polak, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}