Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-04-14 @ 12:05 PM
Study NCT ID:
NCT05458167
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HEdia eXercise Algorithm - HEXA Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Glycemic variability of Hedia Diabetes Assistant bolus calculator with physical activity module', 'timeFrame': '24-hour period starting one hour before exercise', 'description': "To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of glycaemic variability (coefficient of variation and standard deviation)."}, {'measure': 'Daily insulin requirement of Hedia Diabetes Assistant bolus calculator with physical activity module', 'timeFrame': '24-hour period starting one hour before exercise', 'description': 'To compare the daily intake of insulin in adults with type 1 diabetes mellitus utilising the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to their habitual diabetes management during a 24-hour period starting one hour before exercise.'}, {'measure': 'Daily correctional actions of Hedia Diabetes Assistant bolus calculator with physical activity module', 'timeFrame': '24-hour period starting one hour before exercise', 'description': 'To compare the number of daily correctional actions (intake of food or injection of insulin) in adults with type 1 diabetes mellitus utilising the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to their habitual diabetes management during a 24-hour period starting one hour before exercise.'}, {'measure': 'Usability of Hedia Diabetes Assistant bolus calculator with physical activity module', 'timeFrame': '1 day', 'description': 'To compare the usability of the physical activity module as part of the Hedia Diabetes Assistant application by System Usability Scale (SUS) in adult patients with type 1 diabetes mellitus.'}], 'primaryOutcomes': [{'measure': 'Time-in-range of Hedia Diabetes Assistant bolus calculator with physical activity module', 'timeFrame': '24-hour period starting one hour before exercise', 'description': "To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-in-range (blood glucose 3.9-10.0 mmol/l)."}], 'secondaryOutcomes': [{'measure': 'Hypoglycemic events of Hedia Diabetes Assistant bolus calculator with physical activity module', 'timeFrame': '24-hour period starting one hour before exercise', 'description': "To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of no. of hypoglycemic events (blood glucose \\< 3.9 mmol/l)."}, {'measure': 'Time-above-range of Hedia Diabetes Assistant bolus calculator with physical activity module', 'timeFrame': '24-hour period starting one hour before exercise', 'description': "To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-above-range (\\>10.0 mmol/l)."}, {'measure': 'Time-below-range of Hedia Diabetes Assistant bolus calculator with physical activity module', 'timeFrame': '24-hour period starting one hour before exercise', 'description': "To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-below-range (blood glucose \\< 3.9 mmol/l)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'A randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module', 'detailedDescription': "Hedia Diabetes Assistant is a software device intended to monitor blood glucose and to support in the decision making of the optimal bolus insulin dose for management of insulin-dependent diabetes by providing the user with an indicative Bolus insulin dose.\n\nThis study has been designed to investigate the safety and efficacy of a digital insulin bolus calculator with a physical activity module that provides guidance on insulin reduction to patients with type 1 diabetes mellitus prior to and after exercise, based on exercise duration and intensity compared with the patients' habitual diabetes management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent.\n* Ability to understand, speak and read Danish fluently.\n* Diagnosis of type 1 diabetes mellitus for ≥12 months.\n* Age between ≥18 and \\<60 years.\n* Minimum one measurement of HbA1c between 6.0 to 8.6 % (42 to 70 mmol/mol) within the last four months. If several measurements, then it is the latest one that counts.\n* Body mass index (BMI) between ≥18.5 and \\<30 kg/m2.\n* Ability to use an Apple® (iOS version 13 and up) or Android® (Android version 8.0 and up) smartphone.\n* Treated with the same pen-based insulin regimen with basal insulin (insulin glargine, degludec, or detemir) and meal time insulin (insulin aspart, lispro, glulisine) for at least the three preceding months.\n* Patients who can perform 45 min. of exercise at moderate intensity on an ergometer bike (investigator assessment).\n* If female participants of childbearing potential; willing to have a pregnancy test performed and to use a highly effective method of contraception.\n\nExclusion Criteria:\n\n* Already using Hedia Diabetes Assistant.\n* Use of human insulin or premixed insulin.\n* Blood pressure \\> 180/105 mmHg.\n* Treatment with sodium-glucose transporter 2-inhibitors, glucagon-like peptide 1 receptor agonists, or glucocorticoids.\n* Job situation entailing night shifts.\n* Fever.\n* A mental state impeding compliance with the protocol.\n* Expected non-compliance with the protocol at the discretion of the principal investigator.\n* Pregnancy.\n* Breast-feeding.\n* Dialysis therapy or eGFR \\< 60 ml/min.\n* Patients diagnosed with claudicatio intermittens, heart failure, ischaemic heart disease or stroke.\n* Patients prescribed with beta blockers.\n* Abuse of alcohol or drugs in the past two years.\n* On-going participation, or participation within the last 3 months, in an organised clinical study in which participants received study medication (investigator assessment).\n* Surgery scheduled for the study duration period.\n* An episode of diabetic ketoacidosis or severe hypoglycaemia requiring third-party assistance within the preceding 6 months.\n* Known gastroparesis.'}, 'identificationModule': {'nctId': 'NCT05458167', 'briefTitle': 'HEdia eXercise Algorithm - HEXA Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hedia ApS'}, 'officialTitle': 'HEdia eXercise Algorithm - HEXA Study. A Randomised Controlled Crossover Pilot Study', 'orgStudyIdInfo': {'id': 'HEXA study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device: Hedia Diabetes Assistant with physical activity module.', 'description': 'The participants will take part in a 45-minute moderate-intensity exercise bout on a stationary ergometer bike. Participants will use the Hedia Diabetes Assistant bolus calculator with the physical activity module (intervention) during a 24-hour period starting one hour before the bout of exercise.', 'interventionNames': ['Device: Hedia Diabetes Assistant bolus calculator with a physical activity module']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual treatment', 'description': 'The participants will take part in a 45-minute moderate-intensity exercise bout on a stationary ergometer bike. Participants will use their habitual diabetes management approach during a 24-hour period starting one hour before the bout of exercise (control).', 'interventionNames': ['Device: Hedia Diabetes Assistant bolus calculator with a physical activity module']}], 'interventions': [{'name': 'Hedia Diabetes Assistant bolus calculator with a physical activity module', 'type': 'DEVICE', 'description': 'Hedia Diabetes Assistant bolus calculator with a physical activity module is a software device that calculates an insulin bolus based on blood glucose, carbohydrates and physical activity.', 'armGroupLabels': ['Device: Hedia Diabetes Assistant with physical activity module.', 'Usual treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'North Zealand Hospital - Hillerød', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Anne Østerskov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hedia ApS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hedia ApS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}