Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 9:04 PM
Study NCT ID:
NCT06147466
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011254', 'term': 'Pregnancy in Diabetics'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in target range', 'timeFrame': '7-9 months', 'description': 'To determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis'}], 'secondaryOutcomes': [{'measure': 'Delivery outcome', 'timeFrame': '7-9 months', 'description': 'delivery outcome will be reported as ,full term birth, pre-term birth, spontaneous abortion, miscarriage or termination.'}, {'measure': 'Maternal outcome', 'timeFrame': '7-9 months', 'description': 'Date and time of hospital admission for delivery and discharge.'}, {'measure': 'Maternal outcome (HTN)', 'timeFrame': '7-9 months', 'description': 'Maternal postpartum diagnosis of hypertension or pre-eclampsia.'}, {'measure': 'Neonatal weight at birth', 'timeFrame': '7-9 months (Delivery of neonate)', 'description': 'Neonatal weight measurement collected from medical chart.'}, {'measure': 'Neonatal outcomes (hypoglycemia)', 'timeFrame': '7-9 months (Delivery of neonate)', 'description': 'Proportion of babies born with hypoglycemia. The lowest recorded glucose value (mmol/L) will be collected for babies born with hypoglycemia'}, {'measure': 'Neonatal outcomes (chromosomal abnormality)', 'timeFrame': '7-9 months (Delivery of neonate)', 'description': 'Proportion of babies born with chromosomal abnormality and type of chromosomal abnormality'}, {'measure': 'Neonatal outcomes (congenital anomaly)', 'timeFrame': '7-9 months (Delivery of neonate)', 'description': 'Proportion of babies born with congenital anomaly and type of congenital anomaly'}, {'measure': 'Neonatal outcomes (birth injury)', 'timeFrame': '7-9 months (Delivery of neonate)', 'description': 'Proportion of babies born with neonatal birth injury and type of injury'}, {'measure': 'Neonatal outcomes (hyperbilirubinemia)', 'timeFrame': '7-9 months (Delivery of neonate)', 'description': 'Proportion of babies born with neonatal hyperbilirubinemia requiring treatment (• phototherapy \\> 6 continuous hours, an exchange transfusion, intravenous gamma globulin or required re-admission into hospital during the first 7 days of life)'}, {'measure': 'Neonatal outcomes (neonatal intensive care admission)', 'timeFrame': 'Delivery of neonate to 6 weeks postpartum', 'description': 'Proportion of babies admitted to neonatal intensive care admission'}, {'measure': 'Covariates (maternal obesity)', 'timeFrame': '16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum', 'description': 'maternal weight will be collected/measured'}, {'measure': 'Covariates (maternal ethnicity)', 'timeFrame': 'Enrollment (16-24 weeks gestation)', 'description': 'maternal ethnicity will be collected'}, {'measure': "Covariates (Mother's total household income)", 'timeFrame': 'enrollment 16-24 weeks gestation', 'description': 'total household income will be collected'}, {'measure': 'Adverse events', 'timeFrame': '7-9 months', 'description': 'Adverse events description and time of occurrence will be recorded when applicable'}, {'measure': 'Blood Insulin', 'timeFrame': 'at 16-24 weeks gestation', 'description': 'blood insulin measured in pmol/L.'}, {'measure': 'Measures of insulin resistance (HOMA-IR )', 'timeFrame': 'at 16-24 weeks gestation', 'description': 'Homeostatic Model Assessment for Insulin Resistance ( HOMA-IR ) index will be calculated suing blood insulin and blood glucose'}, {'measure': 'Mean blood glucose measurement', 'timeFrame': 'at 16-24 weeks gestation', 'description': 'Blood glucose measured in mmol/L'}, {'measure': 'Diabetes distress', 'timeFrame': 'at 16-24 weeks gestation and at 34 weeks gestation', 'description': 'Using Diabetes Distress Screening Scale (DDSS17). The scale yields an overall distress score based on the average of response on the 1-6 scale for all 18 items. The DDS-17 identifies three levels of specificity of diabetes distress information for use in clinical care, from overall emotional distress related to diabetes to highly specific sources of diabetes distress. Higher score is worse.'}, {'measure': 'Sleep quality', 'timeFrame': 'at 16-24 weeks gestation and at 34 weeks gestation', 'description': 'Using the Berlin Questionnaire. The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive'}, {'measure': 'Sleep apnea', 'timeFrame': 'at 16-24 weeks gestation and at 34 weeks gestation', 'description': 'Using the Berlin Questionnaire. The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive'}, {'measure': 'Perceived social support', 'timeFrame': '16-24 weeks gestation', 'description': 'Using the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS is a 12-item scale that measures the adequacy of social support. It consists of 3 subgroups that include items about family, friends and social support from a special person. It consists of 4 items for each group and each item is graded on a 7-item likert scale. A high total score indicates a high level of perceived social support.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['glucose range', 'neonatal outcomes', 'glycemic control', 'hypoglycemia', 'insulin resistance', 'preganant', 'pregnancy', 'CGM', 'Continuous Glucose Monitoring', 'Dexcom', 'maternal outcomes', 'Pregnancy in Diabetes'], 'conditions': ['Diabete Type 2', 'Pregnancy in Diabetic']}, 'descriptionModule': {'briefSummary': 'Prospective cohort study to determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant Women with Type 2 diabetes with either a HbA1c of \\>6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a HbA1c of \\>6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above.\n2. ≤14 weeks gestation,\n3. age ≥18 years\n4. Willingness to use the study devices a minimum of 10 days per trimester\n5. Able to provide informed consent\n6. Have access to email\n\nExclusion Criteria:\n\n1. Non-type 2 diabetes\n2. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids\n3. Known or suspected allergy against insulin\n4. Women with nephropathy (eGFR\\<30), severe autonomic neuropathy, uncontrolled gastroparesis that, as judged by the investigator, is likely to interfere with the normal conduct of the study and interpretation of study results\n5. Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance\n6. Unable to communicate effectively in English as judged by the investigator\n7. Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results'}, 'identificationModule': {'nctId': 'NCT06147466', 'acronym': 'Timely', 'briefTitle': 'Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)', 'orgStudyIdInfo': {'id': '21-0065-E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dexcom Continuous Glucose Monitoring', 'type': 'DEVICE', 'description': 'A continuous glucose monitor (CGM) is a wearable device that tracks blood glucose (sugar) every few minutes, throughout the day and night. The readings are relayed in real time to a device which can be read by the patient, caregiver or health-care provider, even remotely'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Denice Feig, MD', 'role': 'CONTACT'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Denice Feig, MD, MSc, FRCPC', 'role': 'CONTACT', 'email': 'Denice.Feig@sinaihealth.ca', 'phone': '416-586-8590'}, {'name': 'Silva Darrouj, HBSc', 'role': 'CONTACT', 'email': 'silva.darrouj@sinaihealth.ca', 'phone': '416-586-4800', 'phoneExt': '3946'}], 'overallOfficials': [{'name': 'Denice Feig', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manitoba', 'class': 'OTHER'}, {'name': "Women's College Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}