Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05977205
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2023-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 Glycemic Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012934', 'term': 'Social Isolation'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-24', 'size': 423813, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2023-07-28T05:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 492}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': 'HbA1c measurement during lockdown (8 - 11 weeks after the start of the lockdown (March 15th 2020)) compared to last measurement before lockdown (last known measurement before March 15th 2020)', 'description': 'HbA1c (mmol/mol Hb)'}], 'secondaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '2 week period during lockdown compared to 2 week period before lockdown', 'description': 'Continuous Glucose Measurement parameters (time in range, time above range, time below range)'}, {'measure': 'Stress', 'timeFrame': 'PSS During lockdown + self-comparison change to before lockdown (questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))', 'description': 'Perceived Stress Scale (PSS) + self-reported change in stress during lockdown compared to before lockdown'}, {'measure': 'Anxiety', 'timeFrame': 'Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))', 'description': 'Self-reported change in anxiety during lockdown compared to before lockdown'}, {'measure': 'Weight', 'timeFrame': 'Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))', 'description': 'Self-reported weight change during lockdown compared to before lockdown'}, {'measure': 'Physical activity', 'timeFrame': 'Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))', 'description': 'Self-reported change in physical activity during lockdown compared to before lockdown'}, {'measure': 'Glycemic control and insulin requirements', 'timeFrame': 'Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))', 'description': 'Self-reported change in difficulty with glycemic control and insulin requirements during lockdown compared to before lockdown'}, {'measure': 'Social isolation behaviour', 'timeFrame': 'Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))', 'description': 'Self-reported social isolation behaviour during lockdown'}, {'measure': 'Fear of COVID-19 infection', 'timeFrame': 'Questionnaire filled in between 8 - 11 weeks after the start of the lockdown (March 15th 2020))', 'description': 'Fear of contracting COVID-19, scored using a Visual Analogue Scale (1-10), during lockdown'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 Pandemic', 'Type 1 Diabetes', 'Type 2 Diabetes', 'Beta Cell Transplantation', 'Social isolation', 'Glycemic control', 'Distress', 'COVID-19 Lockdown'], 'conditions': ['Type 1 Diabetes', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38601276', 'type': 'DERIVED', 'citation': 'Landstra CP, Ruissen MM, Regeer H, Nijhoff MF, Ballieux BEPB, van der Boog PJM, de Vries APJ, Huisman SD, de Koning EJP. Impact of a Public Health Emergency on Behavior, Stress, Anxiety and Glycemic Control in Patients With Pancreas or Islet Transplantation for Type 1 Diabetes. Transpl Int. 2024 Mar 27;37:12278. doi: 10.3389/ti.2024.12278. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': "Diabetes mellitus is a chronic disease characterized by the inability of the body to maintain normoglycemia. Treatment of diabetes relies mostly on diabetes self-management, requiring a large investment of time and energy on a daily basis. Psychological wellbeing, behavioral patterns and social context play a major role in diabetes self-management and glycemic control. Social isolation behavior (self-quarantining) may impact glycemic control by influencing daily routines, therapy adherence, physical activity, and self-measurement and eating behaviors. Therefore, a period of nationwide self-quarantine, such as during the lockdown issued during the COVID-19 outbreak in the Netherlands, may have a large effect on glycemic control in patients with diabetes.\n\nIn this observational cross sectional study, we aim to assess the impact of long-term self-quarantine on glycemic control, diabetes self-management and distress in patients with type 1 and type 2 diabetes mellitus.\n\nA specific subgroup of patients with T1D are those with complicated diabetes who have received a pancreas or islet transplantation and use immunosuppression, having multiple risk factors for severe COVID-19. The impact of lockdown strategies on mental and physical health is expectedly even greater in patients at even higher risk for severe COVID-19. We therefore additionally investigated differences in behavioral, mental and physical implications of a nationwide lockdown on patients with type 1 diabetes with and without islet or pancreas transplantation.\n\nMeasurements will be performed during the lockdown period. Patients will be asked to perform a fingerprick HbA1c measurement once, sent back to the LUMC by mail. Data from continuous or flash glucose monitoring devices will be collected according to standard clinical practice. Furthermore, patients will be asked to fill out an online questionnaire once on diabetes self-management behavior, well-being and distress, along with questions about health status, level of education, medication use, employment, social situation and the impact of self-quarantine on daily routines. In this questionnaire, we ask patients to compare certain aspects of their life (e.g. anxiety, stress, weight, physical activity, glycemic control) at the time of the lockdown to before the lockdown. Data on demographics, type of diabetes, weight, BMI and HbA1c prior to the COVID-19 outbreak will be derived from the patient's electronic health file."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 1 diabetes (with and without islet or pancreas transplantation) and type 2 diabetes, recruited from the diabetes outpatient clinic of the LUMC.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with type 1 or type 2 diabetes\n* Ability to perform fingerpricks\n* Sufficient comprehension of the Dutch language\n* Ability to fill out online questionnaires\n\nExclusion Criteria:\n\n* Pregnancy\n* Newly diagnosed malignancy, with the exclusion of non-melanoma skin cancer, in the previous 6 months\n* Chemotherapy or immunotherapy for malignancy\n* Admission to hospital or rehabilitation center'}, 'identificationModule': {'nctId': 'NCT05977205', 'briefTitle': 'COVID-19 Glycemic Control Study', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'The Impact of Self-quarantining on Glycemic Control, Diabetes Self-management and Distress During the Coronavirus Outbreak', 'orgStudyIdInfo': {'id': 'NL73778.058.20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 Diabetes', 'description': '280 patients with type 1 diabetes', 'interventionNames': ['Other: No interventions, observational study']}, {'label': 'Type 2 Diabetes', 'description': '155 patients with type 2 diabetes', 'interventionNames': ['Other: No interventions, observational study']}, {'label': 'Type 1 Diabetes with Islet or Pancreas Transplantation', 'description': '23 patients with islet transplantation, 7 with pancreas transplantation, 27 with simultaneous pancreas-kidney transplantation', 'interventionNames': ['Other: No interventions, observational study']}], 'interventions': [{'name': 'No interventions, observational study', 'type': 'OTHER', 'description': 'Not applicable, no interventions, observational study', 'armGroupLabels': ['Type 1 Diabetes', 'Type 1 Diabetes with Islet or Pancreas Transplantation', 'Type 2 Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Eelco JP de Koning, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Professor in Diabetology', 'investigatorFullName': 'Eelco JP de Koning', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}