Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT04949867
Status:
COMPLETED
Last Update Posted:
2022-08-18
First Post:
2021-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dual-Hormone Closed-Loop Glucose Control in Adolescents 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005934', 'term': 'Glucagon'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}], 'ancestors': [{'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-01', 'size': 1004884, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-23T09:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': ". For dual-hormone control, the study pumps will be filled with FiAsp® and GlucaGen®. For single-hormone control, the study pumps have been filled with FiAsp® and isotonic saline. Pump filling is conducted before the participant arrives at the research facility. The glucagon/saline pump and the insulin pump are clearly marked and cannot be confused. The participants are blinded to the treatment, as isotonic saline by its looks is indistinguishable from GlucaGen®. The placebo pump ('dummy' pump) will not infuse the saline and cannot be detected by the participant."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A randomized, single-blinded, cross-over study of glycemic control during dual-hormone therapy compared with single-hormone therapy in adolescents with type 1 diabetes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of time with glucose values < 3.9 mmol/l as measured by the continuous glucose monitor', 'timeFrame': '26 hours during closed-loop control', 'description': 'Percentage'}], 'secondaryOutcomes': [{'measure': 'Number of carbohydrate interventions to treat hypoglycemia', 'timeFrame': '26 hours during closed-loop control'}, {'measure': 'Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by continuous glucose monitor and plasma glucose', 'timeFrame': '26 hours during closed-loop control', 'description': 'Percentage'}, {'measure': 'Percentage of time with glucose values < 3.9 mmol/l as measured by plasma glucose', 'timeFrame': '26 hours during closed-loop control', 'description': 'Percentage'}, {'measure': 'Percentage of time with glucose values in the range > 13.9 mmol/l measured by continuous glucose monitor and plasma glucose', 'timeFrame': '26 hours during closed-loop control', 'description': 'Percentage'}, {'measure': 'Percentage of time with glucose values < 3.0 mmol/l as measured by continuous glucose monitor and plasma glucose', 'timeFrame': '26 hours during closed-loop control', 'description': 'Percentage'}, {'measure': 'Mean blood glucose value measured by continuous glucose monitor and plasma glucose', 'timeFrame': '26 hours during closed-loop control', 'description': 'mmol/L'}, {'measure': 'Number of hypoglycemic episodes < 3.9 mmol/l on continuous glucose monitor and plasma glucose', 'timeFrame': '26 hours during closed-loop control', 'description': 'No.'}, {'measure': 'Continuous glucose monitored glycemic variability measured as SD', 'timeFrame': '26 hours during closed-loop control', 'description': 'mmol/L'}, {'measure': 'Continuous glucose monitored glycemic variability measured as CV', 'timeFrame': '26 hours during closed-loop control', 'description': 'percentage'}, {'measure': 'Composite outcome: Percentage of participants achieving (1) time in range (3.9-10) > 70 %, (2) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (3) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by CGM and YSI', 'timeFrame': '26 hours during closed-loop control', 'description': 'percentage'}, {'measure': 'Total insulin dose', 'timeFrame': '26 hours during closed-loop control', 'description': 'units'}, {'measure': 'Total glucagon dose', 'timeFrame': '26 hours during closed-loop control', 'description': 'mg'}, {'measure': 'Number of manual insulin boluses', 'timeFrame': '26 hours during closed-loop control', 'description': 'No.'}, {'measure': 'Number of adverse events - Nausea', 'timeFrame': '26 hours during closed-loop control', 'description': 'No of event if visual analog scale (0-100) increase \\>10 from baseline'}, {'measure': 'Number of adverse events - Headache', 'timeFrame': '26 hours during closed-loop control', 'description': 'No of event if visual analog scale (0-100) increase \\>10 from baseline'}, {'measure': 'Number of adverse events - Palpitation', 'timeFrame': '26 hours during closed-loop control', 'description': 'No of event if visual analog scale (0-100) increase \\>10 from baseline'}, {'measure': 'Number of vomits', 'timeFrame': '26 hours during closed-loop control', 'description': 'No of event if visual analog scale (0-100) increase \\>10 from baseline'}, {'measure': 'Difference between actual and participant-estimated carbohydrate content in meals', 'timeFrame': '26 hours of closed-loop glucose control', 'description': 'g per meal'}, {'measure': 'Mean Borg scale', 'timeFrame': 'During 45 minutes exercise', 'description': 'Scale of perceived exertion from 6 (no effort activity) to 20 (max effort activity)'}, {'measure': 'Physical activity intensity measured by ActiGraph GT9X Link', 'timeFrame': '26 hours', 'description': 'Percentage of sedentary activity'}, {'measure': 'Sleep efficiency measured by ActiGraph GT9X Link', 'timeFrame': '26 hours', 'description': 'The ratio of total sleep time to time in bed'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Objective:\n\nTo assess the efficacy and safety of an insulin-glucagon dual-hormone (DH) closed-loop system compared with an insulin-only single-hormone (SH) closed-loop system in adolescent with type 1 diabetes.\n\nMethods:\n\nIn a 26-h, randomized, crossover, inpatient study, 20 children and adolescents with type 1 diabetes used two modes of the DiaCon Artificial Pancreas system: DH and SH closed-loop control. During each study period, participants will have one overnight stay, received three meals and performed exercise for 45 min (bicycle with estimated 50% V02max).\n\nEndpoint:\n\nThe primary endpoint is sensor-derived percentage of time in hypoglycemia (\\<3.9 mmol/L).', 'detailedDescription': "Upon arrival at the research facility at Steno Diabetes Center Copenhagen, the participant's own pump and CGM are disconnected, and the two study pumps are attached. For dual-hormone control, the study pumps will be filled with FiAsp® and GlucaGen®. For single-hormone control, the study pumps have been filled with FiAsp® and isotonic saline.\n\nIn addition, participants are provided with a blinded wearable activity and sleep monitoring device (ActiGraph GT9X Link, Pensacola, FL) for activity level estimation and sleep assessment during study participation. The Actigraph is connected to a Bluetooth® Polar heart rate monitors during the exercise session.\n\nFemale participants deliver a urine sample for pregnancy testing. A sampling cannula is placed in an antecubital vein. The CGM will be calibrated with fingerpick glucose meter (Contour next®, Ascensia Diabetes Care) before initiating the closed-loop control. Even though it is not needed to calibrate the sensor, the accuracy of the sensor is better after one calibration.\n\nAt day 1 17:00 the study is initiated, and the closed-loop system takes over glucose control. Except from the control approach (single- vs. dual-hormone), the study days are identical. During the study visit, participants can move around freely, but they can only perform actual exercise during the stationary bike exercise session at day 2 16:30. At nighttime, the participants are encouraged to be in bed and, if possible, sleep.\n\nAt predefined timepoints, the investigators measure blood pressure and pulse, and the investigators ask the participants to rate their nausea level on a visual analog scale (VAS) from 1 to 100 to assess possible side effects of glucagon (vomiting rates as 100). In addition, the investigators ask them to self-rate blood glucose levels before bedtime (23:00), upon wake-up (07:00-08:00), before each meal, before exercise, and every 10 minutes during exercise.\n\nSingle-hormone and dual-hormone closed-loop control study sessions end 26 hours after study start. The study pumps and the CGMs are disconnected and the participants reconnect their own pumps and CGMs.\n\nThe two study sessions are separated by at least 36 hours."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age = 13-17 years\n* T1D duration ≥ 2 years\n* Insulin pump therapy ≥ 1 year\n* Using CGM or isCGM (Flash Libre)\n* HbA1c ≤ 9.0% (75 mmol/mol)\n* Using carbohydrate counting\n\nExclusion Criteria:\n\n* Allergy to glucagon or lactose\n* Allergy to faster insulin aspart (FiAsp)\n* Pheochromocytoma\n* Self-reported lack of hypoglycemia symptoms when blood glucose is \\< 3.0 mmol/l\n* Inability to follow study procedures, e.g. exercise, sleeping, blood sampling, and meal intake\n* Pregnancy, nursing, plan to become pregnant or sexually active and not using adequate contraceptive methods (intrauterine device, contraceptive pill, patch or injection)\n* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation\n* Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation"}, 'identificationModule': {'nctId': 'NCT04949867', 'acronym': 'DHCL2021', 'briefTitle': 'Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'H-21000207'}, 'secondaryIdInfos': [{'id': '2020-005836-31', 'type': 'EUDRACT_NUMBER'}, {'id': '2021-0409-34', 'type': 'OTHER', 'domain': 'Eudramed CIV-ID-nr.'}, {'id': 'PD002-19', 'type': 'OTHER_GRANT', 'domain': 'Danish Diabetes Academy'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dual-hormone Closed-loop', 'description': 'FiAsp® and GlucaGen®.', 'interventionNames': ['Drug: Glucagon', 'Device: Closed-loop System']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Single-Hormone Closed-loop', 'description': 'FiAsp® and isotonic saline.', 'interventionNames': ['Device: Closed-loop System']}], 'interventions': [{'name': 'Glucagon', 'type': 'DRUG', 'otherNames': ['GlucaGen, Novo Nordisk,'], 'description': 'Glucagon is filled in the pump and given automatically in case of hypoglycemia or pending hypoglycemia.', 'armGroupLabels': ['Dual-hormone Closed-loop']}, {'name': 'Closed-loop System', 'type': 'DEVICE', 'otherNames': ['Saline'], 'description': 'Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm.', 'armGroupLabels': ['Dual-hormone Closed-loop', 'Single-Hormone Closed-loop']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Steno Diabetes Center Copenhagen', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'From 1 year to 10 years after completion', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Denmark', 'class': 'OTHER'}, {'name': 'Herlev Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}