Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-03 @ 8:28 AM
Study NCT ID:
NCT04825366
Status:
RECRUITING
Last Update Posted:
2024-11-06
First Post:
2021-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D000070276', 'term': 'Heart Rate Determination'}], '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'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D010808', 'term': 'Physical Examination'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2021-03-28', 'studyFirstSubmitQcDate': '2021-03-28', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Gold score', 'timeFrame': '12 weeks', 'description': 'The Gold method is used to assess impaired awareness of hypoglycemia. The scale is from 1 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia'}], 'secondaryOutcomes': [{'measure': 'Change in the Clarke score', 'timeFrame': '12 weeks', 'description': 'The Clarke questionnaire is used to assess impaired awareness of hypoglycemia. The scale is from 0 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia'}, {'measure': 'Change in the score of the Edinburgh Hypoglycemia Symptom Scale', 'timeFrame': '12 weeks', 'description': 'Symptoms of hypoglycemia'}, {'measure': 'Change in the score of the BAPAD questionnaire', 'timeFrame': '12 weeks', 'description': 'Barriers to physical activity. The score can be between 12 and 84. A higher score means more barriers to physical activity.'}, {'measure': 'Change in the score of the Hypoglycemia Fear Survey II', 'timeFrame': '12 weeks', 'description': 'Fear of hypoglycemia. The score can be between 0 and 132. A higher score means higher level of fear of hypoglycemia.'}, {'measure': 'Change in physical activity practice', 'timeFrame': '12 weeks', 'description': 'Score of the International Physical Activity Questionnaire'}, {'measure': 'Change in well-being', 'timeFrame': '12 weeks', 'description': 'Score of the WHO-5 well-being index. The score can be between 0 and 5. Higher scores means better well-being.'}, {'measure': 'Change in treatment satisfaction', 'timeFrame': '12 weeks', 'description': 'Score of the Diabetes Treatment Satisfaction questionnaire. The score can be between 0 and 36. Higher score means better satisfaction.'}, {'measure': 'Percentage of participants who no longer have impaired awareness of hypoglycemia', 'timeFrame': '12 weeks'}, {'measure': 'Percentage of time of glucose levels spent < 4.0 mmol/L', 'timeFrame': '12 weeks', 'description': 'Based on continous glucose monitor data'}, {'measure': 'Percentage of time of glucose levels spent < 3.0 mmol/L', 'timeFrame': '12 weeks', 'description': 'Based on continous glucose monitor data'}, {'measure': 'Percentage of time of glucose levels spent between 3.9-10.0 mmol/L', 'timeFrame': '12 weeks', 'description': 'Based on continous glucose monitor data'}, {'measure': 'Percentage of time of glucose levels spent > 10.0 mmol/L', 'timeFrame': '12 weeks', 'description': 'Based on continous glucose monitor data'}, {'measure': 'Standard deviation of glucose levels', 'timeFrame': '12 weeks', 'description': 'Based on continous glucose monitor data'}, {'measure': 'Coefficient of variation of glucose levels', 'timeFrame': '12 weeks', 'description': 'Based on continous glucose monitor data'}, {'measure': 'Number of hypoglycemic events', 'timeFrame': '12 weeks', 'description': 'Glucose levels \\< 4 mmol/L or \\< 3 mmol/L'}, {'measure': 'Number of treated hypoglycemic events', 'timeFrame': '12 weeks', 'description': 'Number of time that carbohydrates were taken to treat a hypoglycemia event'}, {'measure': 'Number of severe hypoglycemia', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Hypoglycemia unawareness', 'Education', 'Avoidance of hypoglycemia', 'High intensity interval training'], 'conditions': ['Type 1 Diabetes', 'Hypoglycemia Unawareness']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate if the addition of a 12-week program of home-based high intensity interval training to a standard educational program aiming at preventing hypoglycemia episodes will restore hypoglycemia awareness in people living with type 1 diabetes and impaired awareness of hypoglycemia to a further extent than a standard educational program alone.\n\nParticipants will be randomized for 12 weeks to the standard educational program with or without high intensity interval training. The Gold method will be used to identify people with impaired awareness of hypoglycemia.\n\nThe educational program will consist of two education sessions on avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a CGM/Flash-GM and understand CGM/Flash-GM reports to adjust insulin doses.\n\nParticipants randomized to the training program will be asked to train three times per week for 12 weeks following the home-based program that will be provided to them. Participants will be asked to perform at least 2 training sessions per week (ideally all 3 sessions) with the exercise specialist on a virtual platform.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females aged between 18 and 65 years old.\n2. Clinical diagnosis of type 1 diabetes for at least five years.\n3. Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid or basal). The type of insulin should be stable for at least 1 month. Participants not using an insulin analog will be offered the opportunity to switch to an insulin analog and this will be done at least 1 month before inclusion.\n4. Impaired awareness of hypoglycemia (Gold score ≥ 4).\n5. HbA1c ≤ 10%\n6. Using a continuous glucose monitor or being willing to start using one for the study\n7. Having an electronic device supporting the Polar Beat application (heart rate monitor).\n\nExclusion Criteria:\n\n1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially advanced peripheral neuropathy with significantly lower limb reduced proprioceptive perception) or severe proliferative retinopathy as reported by the patient and/or judged by the investigator.\n2. High risk foot problem (e.g., previous amputation, history of foot wound, known severe neuropathy or peripheral arterial disease)\n3. Recent (\\< 3 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery or history of significant heart disease.\n4. Known significant cardiac rhythm abnormality based on investigator judgment.\n5. Abnormal blood panel and/or anemia (Hb \\< 100g/L).\n6. Ongoing pregnancy or breastfeeding.\n7. Severe hypoglycemic episode or diabetic ketoacidosis within 1 month of screening.\n8. Taking any medication that affects heart rate (e.g., beta-blockers).\n9. Uncontrolled hypertension (blood pressure \\>160/100 mm Hg).\n10. Uncontrolled angina.\n11. Treatment with oral steroids within the last 3 months.\n12. History of significant lung disease that would limit exercise.\n13. Seizure within the last 3 months.\n14. Participation in high-intensity interval training (or equivalent) in the past 6 months.\n15. Physical ability preventing the completion of the 12-week training program (e.g., orthopedic limitation).\n16. Inability to give consent.'}, 'identificationModule': {'nctId': 'NCT04825366', 'acronym': 'FEEL-HIIT', 'briefTitle': 'Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Recherches Cliniques de Montreal'}, 'officialTitle': 'Restoration of Hypoglycemia Awareness With Home-based High Intensity Interval Training in Adults With Type 1 Diabetes and Impaired Awareness of Hypoglycemia', 'orgStudyIdInfo': {'id': '2021-1117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard educational program', 'description': 'Participants will be closely followed by a team of diabetes specialists. Participants will attend two education sessions to discuss the following topics: avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a continuous glucose monitor (CGM) and understand CGM reports to adjust insulin doses.', 'interventionNames': ['Device: Continuous glucose monitoring device', 'Other: Gold method', 'Other: Clarke questionnaire', 'Other: Edinburgh Hypoglycemia Symptom Scale', 'Other: BAPAD questionnaire', 'Other: Hypoglycemia Fear Survey II', 'Other: Physical activity questionnaire', 'Other: Well-being', 'Other: Treatment satisfaction', 'Other: Hypoglycemia diary', 'Device: Piezo RxD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard educational program combined with high intensity interval training', 'description': 'Participants will be closely followed by a team of diabetes specialists. Participants will attend two education sessions to discuss the following topics: avoidance of hypoglycemia, causes of hypoglycemia, treatment (e.g. glucagon) of hypoglycemia, how to better recognize hypoglycemia symptoms, understand how to use a continuous glucose monitor (CGM) and understand CGM reports to adjust insulin doses.\n\nEach study participant will be asked to train 3 times per week following the home-based program that will be provided to them. Participants will be asked to perform at least 2 training sessions per week with the exercise specialist on a virtual platform. The training session will consist of a 3 to 5-minute low-intensity warm-up followed by 6 to 12 1-minute bouts of high-intensity exercise interspersed with 1-minute bouts of low-intensity exercise. Each session will end with a 3-minutes cool-down period.', 'interventionNames': ['Device: Continuous glucose monitoring device', 'Other: Gold method', 'Other: Clarke questionnaire', 'Other: Edinburgh Hypoglycemia Symptom Scale', 'Other: BAPAD questionnaire', 'Other: Hypoglycemia Fear Survey II', 'Other: Physical activity questionnaire', 'Other: Well-being', 'Other: Treatment satisfaction', 'Other: Hypoglycemia diary', 'Device: Piezo RxD', 'Device: Heart rate monitor', 'Other: Exercise diary']}], 'interventions': [{'name': 'Continuous glucose monitoring device', 'type': 'DEVICE', 'description': 'Participants will have to wear their continuous glucose monitoring device throughout the study.', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Gold method', 'type': 'OTHER', 'description': 'The Gold method will be used to assess impaired awareness of hypoglycemia', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Clarke questionnaire', 'type': 'OTHER', 'description': 'The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Edinburgh Hypoglycemia Symptom Scale', 'type': 'OTHER', 'description': 'The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'BAPAD questionnaire', 'type': 'OTHER', 'description': 'The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Hypoglycemia Fear Survey II', 'type': 'OTHER', 'description': 'The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Physical activity questionnaire', 'type': 'OTHER', 'description': 'The International Physical Activity Questionnaire will be used to assess physical activity practice', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Well-being', 'type': 'OTHER', 'description': 'The WHO-5 well-being index will be used to assess well-being.', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Treatment satisfaction', 'type': 'OTHER', 'description': 'The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Hypoglycemia diary', 'type': 'OTHER', 'description': 'Participants will be asked to record in a diary treatments for hypoglycemic events', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Piezo RxD', 'type': 'DEVICE', 'description': 'Participants will be asked to wear a pedometer throughout the study', 'armGroupLabels': ['Standard educational program', 'Standard educational program combined with high intensity interval training']}, {'name': 'Heart rate monitor', 'type': 'DEVICE', 'description': 'During training sessions, participants will be asked to wear a heart rate monitor', 'armGroupLabels': ['Standard educational program combined with high intensity interval training']}, {'name': 'Exercise diary', 'type': 'OTHER', 'description': 'Before each training session, participants will be asked to note in a diary their glucose levels, if they have taken a snack or not and if insulin was administered. After each training session, participants will be asked to note that same information. In addition, they will be asked to note their bedtime blood glucose, if they have taken a bedtime snack and if adjustment to insulin doses was made.', 'armGroupLabels': ['Standard educational program combined with high intensity interval training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2W 1R7', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Roxane St-Amand', 'role': 'CONTACT', 'email': 'roxane.st-amand@ircm.qc.ca', 'phone': '514-987-5597'}, {'name': 'Rémi Rabasa-Lhoret', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut de recherches cliniques de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Roxane St-Amand', 'role': 'CONTACT', 'email': 'roxane.st-amand@ircm.qc.ca', 'phone': '514-987-5597'}], 'overallOfficials': [{'name': 'Rémi Rabasa-Lhoret', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de recherches cliniques de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherches Cliniques de Montreal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Rémi Rabasa-Lhoret', 'investigatorAffiliation': 'Institut de Recherches Cliniques de Montreal'}}}}