Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 8:50 PM
Study NCT ID:
NCT04506151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-07', 'size': 1175282, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-13T16:27', 'hasProtocol': True}, {'date': '2023-11-22', 'size': 302201, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-06T09:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sleep optimization intervention will be compared to an attention control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep variability', 'timeFrame': 'Change from week 0, 6, 12, 24', 'description': 'Standard deviation total sleep time for one week'}, {'measure': 'Sleep duration', 'timeFrame': 'Change from weeks 0. 6, 12, 24', 'description': 'total sleep time'}, {'measure': 'Glycemic control', 'timeFrame': 'Change from week 0. 6, 12, 24', 'description': 'HbA1c blood test'}], 'secondaryOutcomes': [{'measure': 'Diabetes distress', 'timeFrame': 'Change from week 0. 6, 12, 24', 'description': 'T1D Diabetes Distress Scale score- higher numbers indicate greater distress'}, {'measure': 'Self-management behavior', 'timeFrame': 'Change from week. 6, 12, 24', 'description': 'Self-Management Questionnaire score- higher numbers indicate better self-management'}, {'measure': 'Fatigue', 'timeFrame': 'Change from week 0. 6, 12, 24', 'description': 'Patient Reported Outcomes Measure (PROMIS) fatigue scale score - higher numbers greater fatigue'}, {'measure': 'Mood', 'timeFrame': 'Change from week 0. 6, 12, 24', 'description': 'Center for Epidemiological Studies - Depressed Mood score - Higher numbers more depressive mood'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '35986415', 'type': 'DERIVED', 'citation': 'Martyn-Nemeth P, Duffecy J, Quinn L, Reutrakul S, Steffen AD, Burke L, Clark Withington MH, Irsheed GA, Perez R, Park M, Saleh A, Mihailescu D, Baron KG. Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial. Trials. 2022 Aug 19;23(1):686. doi: 10.1186/s13063-022-06565-6.'}]}, 'descriptionModule': {'briefSummary': 'Up to 40% of adults with type 1 diabetes have insufficient sleep which is associated with negative health consequences including poor blood glucose control and greater diabetes complications. In this study, a sleep intervention (Sleep-Opt) that uses wearable sleep tracking technology, telephone coaching and informational content designed to improve sleep and glycemic control in working-age adults with type 1 diabetes. Sleep-Opt could lead to reduced development of diabetes complications and improve quality of life for adults with type 1 diabetes.', 'detailedDescription': 'Despite improvements in treatment regimens and technology, less than 20% of adults with type 1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially modifiable target for improving glycemic control. Diabetes distress, poor self-management behaviors, and reduced quality of life (QoL) have also been linked to sleep variability and insufficient sleep duration. The American Diabetes Association Standards of Medical Care in Diabetes incorporated sleep as an important component of the medical evaluation in persons with diabetes. However, no specific recommendation was given as to how to improve sleep. A significant gap of knowledge exists regarding the effects of sleep optimization on glycemic control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability, sleep duration and glycemic control (A1C); other glycemic parameters (glycemic variability, time in range), diabetes distress, self-management behavior, QoL, and other patient reported outcomes in working-age adults with T1D and habitual increased sleep variability or short sleep duration. To achieve these aims, a randomized controlled trial is planned in 120 working age adults (18 to 65 years) with T1D. Participants will be screened for habitual sleep variability (\\> 1 hour/week) or insufficient sleep duration (\\< 6.5 hours per night). Eligible subjects will be randomized to the Sleep-Opt group or healthy living attention control group for twelve weeks. A one-week run-in period is planned, with baseline measures of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic measures: glycemic variability and time in range using continuous glucose monitoring), and other secondary outcomes: diabetes distress, self-management behaviors, quality of life and additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep intervention that this study team developed that leverages the rapidly increasing public interest in sleep tracking by consumers (+500% in 3 years). The behavioral intervention employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone application, and brief telephone counseling. The attention control group will participate in a healthy living information program. At midpoint (Week 6) completion (Week 12) and post-program (Week 24), baseline measures will be repeated to determine differences between the two groups and sustainability of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults aged 18-65 years\n* clinical diagnosis of type 1 diabetes minimum of one year\n* reported habitual sleep variability (1 hour/week or more) or sleep duration less than 6.5 hrs/night during work- or weekdays (confirmed with actigraphy sleep watch)\n* a desire to improve sleep\n* own a smartphone\n\nExclusion Criteria:\n\n* insomnia symptoms\n* at high risk for obstructive sleep apnea\n* severe hypoglycemia episode in the past 6 months (e.g. loss of consciousness)\n* A1C greater than 10%\n* rotating shift or night shift work\n* use of sleep medications/aids\n* renal impairment (estimated glomerular filtration rate \\< 45 ml/min)\n* significant current medical morbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, depression, history of stroke with neurological deficits\n* breast feeding, pregnant, or planning pregnancy'}, 'identificationModule': {'nctId': 'NCT04506151', 'acronym': 'SOPT', 'briefTitle': 'Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2020-0374'}, 'secondaryIdInfos': [{'id': '1R01DK121726', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK121726', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep-Opt', 'description': '12-week intervention that includes self-monitoring, goal setting, motivational enhancement.', 'interventionNames': ['Behavioral: Sleep-Opt']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Living', 'description': '12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.', 'interventionNames': ['Behavioral: Healthy Living']}], 'interventions': [{'name': 'Sleep-Opt', 'type': 'BEHAVIORAL', 'description': '12-week behavioral intervention', 'armGroupLabels': ['Sleep-Opt']}, {'name': 'Healthy Living', 'type': 'BEHAVIORAL', 'description': 'Healthy Living', 'armGroupLabels': ['Healthy Living']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Pamela Martyn-Nemeth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pamela Martyn-Nemeth', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}