Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-25 @ 6:31 PM
Study NCT ID:
NCT06466967
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients (TightT1AHCL)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2024-06-14', 'studyFirstSubmitQcDate': '2024-06-14', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hypoglycemia Fear Survey (HFS questionnaire)', 'timeFrame': '3 months', 'description': 'Assessing the fear of hypoglycemia according to the HFS questionnaire (with values between 24 points and a maximum of 120 indicating a high fear of hypoglycemia) after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Diabetes Treatment Satisfaction Questionnaire (DTSQ)', 'timeFrame': '3 months', 'description': 'Assessing the satisfaction with treatment according to the DTSQ questionnaire (options graduated from 0 to 6 from the lowest to the highest degree of satisfaction, with a minimum of 0 and a maximum of 12) after switching to AHCL with stringent glycemic control targets.'}, {'measure': "Clarke's questionnaire", 'timeFrame': '3 months', 'description': "Assessing the awareness of hypoglycemia according to Clarke's questionnaire (indicates high risk of inadvertent hypoglycemia with a score equal to or greater than four) afterswitching to AHCL with stringent glycemic control targets."}, {'measure': 'Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL)', 'timeFrame': '3 months', 'description': 'Assessing the perceived quality of life according to the EsDQOL questionnaire (with values between 46 and a maximum of 230 which would indicate poor satisfaction with current treatment) after switching to AHCL with stringent glycemic control targets.'}], 'primaryOutcomes': [{'measure': 'Time in Range (TIR) differences', 'timeFrame': '3 months', 'description': 'Percentage differences in time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets.'}], 'secondaryOutcomes': [{'measure': 'Time in Range (TIR) differencies among therapies', 'timeFrame': '3 months', 'description': 'Percentage differences in time in range (TIR 70-180 mg/dL) of interstitial glucose after switching to AHCL with tighter glycemic control targets depending on previous therapy: multi-dose insulin or other AHCL systems with less stringent objectives.'}, {'measure': 'Differences between stringent glucose control targets', 'timeFrame': '3 months', 'description': 'To analyze the possible differences on time in range (TIR) using different interstitial glucose targets (from 80 to 99 mg/dL).'}, {'measure': 'HbA1c differences', 'timeFrame': '3 months', 'description': 'Differences in HbA1c values after switching to AHCL with tighter glycemic control targets.'}, {'measure': 'Usage of AHCL system', 'timeFrame': '3 months', 'description': 'To assess the effect on the time spent using AHCL systems after switching: percentage of time spent using the AHCL system.'}, {'measure': 'MCG adherence', 'timeFrame': '3 months', 'description': 'To assess the effect on the time of use of MCG after switching: percentage of MCG sensor activity time.'}, {'measure': 'Total daily insulin requirements', 'timeFrame': '3 months', 'description': 'To assess the effect on total daily insulin requirements after switching to AHCL therapy with tighter glycemic objective.'}, {'measure': 'Basal daily insulin requirements', 'timeFrame': '3 months', 'description': 'To assess the effect on basal insulin requirements after switching to AHCL therapy with tighter glycemic objective.'}, {'measure': 'Bolus daily insulin requirements', 'timeFrame': '3 months', 'description': 'To assess the effect on insulin bolus requirements after switching to AHCL therapy with tighter glycemic objective.'}, {'measure': 'Time in Tight Range (TTIR 70-140 mg/dL) differences', 'timeFrame': '3 months', 'description': 'Percentage differences in time in tight range (TIR 70-140 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Time Above Range 1 (TAR-1 >180 mg/dL) differences', 'timeFrame': '3 months', 'description': 'Percentage differences in Time Above Range 1 (TAR-1 \\>180 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Time Above Range 2 (TAR-2 >250 mg/dL) differences', 'timeFrame': '3 months', 'description': 'Percentage differences in Time Above Range 2 (TAR-2 \\>250 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Time Below Range 1 (TBR-1 <70 mg/dL) differences', 'timeFrame': '3 months', 'description': 'Time and percentage differences in Time Below Range 1 (TBR-1 \\<70 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Time Below Range 2 (TBR-2 <54 mg/dL) differences', 'timeFrame': '3 months', 'description': 'Time and percentage differences in Time Below Range 2 (TBR-2 \\<54 mg/dL) of interstitial glucose after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Episodes of hyperglycemia level 1 (nº of episodes >180 mg/dL).', 'timeFrame': '3 months', 'description': 'Episodes of hyperglycemia level 1 (nº of episodes \\>180 mg/dL) after switching to aHCL with stringent glycemic control targets.'}, {'measure': 'Episodes of hyperglycemia level 2 (nº of episodes >250 mg/dL).', 'timeFrame': '3 months', 'description': 'Episodes of hyperglycemia level 2 (nº of episodes \\>250 mg/dL) after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Episodes of hypoglycemia level 1 (nº of episodes <70 mg/dL).', 'timeFrame': '3 months', 'description': 'Episodes of hypoglycemia level 1 (nº of episodes \\<70 mg/dL) after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Episodes of hypoglycemia level 2 (nº of episodes <54 mg/dL).', 'timeFrame': '3 months', 'description': 'Episodes of hypoglycemia level 2 (nº of episodes \\<54 mg/dL) after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Nocturnal episodes of hypoglycemia', 'timeFrame': '3 months', 'description': 'Nocturnal episodes of hypoglycemia (nº of episodes \\<70 and \\<54 mg/dL) after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Glycemic variability', 'timeFrame': '3 months', 'description': 'Glycemic variability (measured throught percentage of the coefficient of variation, CV) differences after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Mean interstitial glucose', 'timeFrame': '3 months', 'description': 'Mean interstitial glucose differences after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Glucose management indicator (GMI)', 'timeFrame': '3 months', 'description': 'Glucose management indicator (GMI) differences after switching to AHCL with stringent glycemic control targets.'}, {'measure': 'Acute complications and mortality', 'timeFrame': '3 months', 'description': 'Analyzing the impact of the switch on the frequency of acute complications and mortality due to T1D: severe hypoglycemia, non-acidotic ketotic hyperglycemia, diabetic ketoacidosis, hospital admissions and deaths.'}, {'measure': 'Differences in the Percetage of patients fullfilling the International Consensus of Time in Range', 'timeFrame': '3 months', 'description': 'Differences in the Percetage of patients fullfilling the International Consensus of Time in Range (TAR2 \\<5%, TAR1 \\<25%, TIR \\>70%, TBR1 \\<4%, TBR2 \\<1%, CV\\>36%).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'advanced hybrid closed-loop', 'tight time in range', 'artificial pancreas'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '31177185', 'type': 'BACKGROUND', 'citation': 'Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.'}, {'pmid': '28094136', 'type': 'BACKGROUND', 'citation': 'Bally L, Thabit H, Kojzar H, Mader JK, Qerimi-Hyseni J, Hartnell S, Tauschmann M, Allen JM, Wilinska ME, Pieber TR, Evans ML, Hovorka R. Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):261-270. doi: 10.1016/S2213-8587(17)30001-3. Epub 2017 Jan 14.'}, {'pmid': '31618560', 'type': 'BACKGROUND', 'citation': 'Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.'}, {'pmid': '33453783', 'type': 'BACKGROUND', 'citation': "Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9."}, {'pmid': '37948469', 'type': 'BACKGROUND', 'citation': 'Beato-Vibora PI, Chico A, Moreno-Fernandez J, Bellido-Castaneda V, Nattero-Chavez L, Picon-Cesar MJ, Martinez-Brocca MA, Gimenez-Alvarez M, Aguilera-Hurtado E, Climent-Biescas E, Azriel-Mir S, Rebollo-Roman A, Yoldi-Vergara C, Pazos-Couselo M, Alonso-Carril N, Quiros C. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting. Diabetes Care. 2024 Feb 1;47(2):216-224. doi: 10.2337/dc23-1355.'}, {'pmid': '34534297', 'type': 'BACKGROUND', 'citation': 'El Malahi A, Van Elsen M, Charleer S, Dirinck E, Ledeganck K, Keymeulen B, Crenier L, Radermecker R, Taes Y, Vercammen C, Nobels F, Mathieu C, Gillard P, De Block C. Relationship Between Time in Range, Glycemic Variability, HbA1c, and Complications in Adults With Type 1 Diabetes Mellitus. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e570-e581. doi: 10.1210/clinem/dgab688.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes is a chronic disease with a relevant public health burden. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications. Therefore, the key to prevent and/or reduce the development of these chronic complications lies in an adequate and strict glycemic control.\n\nThis study consist of a prospective analytical clinical study in patients with type 1 diabetes (T1D). The main objective is to analyze the effect on time in range (TIR, 70-180 mg/dL) of interstitial glucose after switching to a tighter glucose objective in advanced hybrid closed-loop (AHCL) treated adult T1D patients previously treated with multiple dose insulin injection (MDI) or other AHCL systems without tighter glucose objective function.', 'detailedDescription': 'Diabetes is a chronic disease with a relevant public health burden. T1D is characterized by the autoimmune destruction of insulin-producing pancreatic beta cells, which requires the administration of exogenous insulin for its treatment. Maintaining blood glucose levels as close to normal as possible is essential to avoid the associated microvascular and macrovascular complications that affect quality of life, as well as morbidity and mortality due to the deleterious long-term effects of suboptimal control. Therefore, the key to prevent and/or reduce the development of these complications lies in adequate and strict glycemic control.\n\nOn the one hand, the use of advanced hybrid closed-loop (AHCL) systems in patients with T1D is associated with improved glycemic control and quality of life in both controlled clinical trials and real-life studies. Since 2021, AHCL systems are considered the standard of care, ahead of traditional MDI. On the other hand, among the adjustment parameters of these systems, each AHCL offers different target levels of glycemic control. There is previous evidence that correlates the use of the more intense modes offered by each of the systems with substantial increases in TIR, improvement in the other glycometric variables, as well as the development of acute or chronic complications. In this regard, a new AHCL system has recently been introduced in Spain: CamAPS FX. It is the first AHCL system with the availability of setting lycemic control targets below the traditional 100 mg/dL limit. This system allows glycemic objective as low as 80 mg/dL.\n\nHowever, there is no information on the benefits and safety of using tighter control targets. The main objective of this study is to analyze the effect on TIR after switching to a tighter glucose objective throught AHCL among adult T1D patients previously treated with MDI or other AHCL systems without this feature.\n\nThis is monocenter prospective analytical clinical study (non-randomized). The target population will be adult T1D patients not meeting glycemic control goals followed in Ciudad Real General University Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with type 1 diabetes and poor prior glycemic control, regardless previous treatment, attended in the Public Health System of Castilla-La Mancha in the Health Area of the Ciudad Real General University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1 diabetes.\n* Age greater than or equal to 18 years.\n* HbA1c \\> 7% (previous poor glycemic control condition).\n* Prior treatment with MDI or aHCL.\n\nExclusion Criteria:\n\n* Other types of diabetes.\n* Pregnancy or pre-conception control.\n* Uncontrolled psychiatric disease.\n* Current or previous treatment with CamAPS-Ypsopump.\n* No glucometric data available during the periods under study.\n* History of severe hypoglycemia.'}, 'identificationModule': {'nctId': 'NCT06466967', 'acronym': 'TightT1AHCL', 'briefTitle': 'Clinical Utility of Tight Objectives of Advanced Hybrid Closed-loop Systems Among Type 1 Diabetes Patients (TightT1AHCL)', 'organization': {'class': 'OTHER', 'fullName': 'Castilla-La Mancha Health Service'}, 'officialTitle': 'Clinical Utility of a Tight Glucose Objectives Through Advanced Hybrid Closed-loop Systems in Adult Patients With Type 1 Diabetes and Poor Glycemic Control', 'orgStudyIdInfo': {'id': 'CI-712'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 diabetes patients treated with AHCL (CamAPS-Ypsopump)', 'description': 'Patients with type 1 diabetes on treatment with AHCL (CamAPS-Ypsopump) and a strict programmed glucose target (80-99 mg/dL).', 'interventionNames': ['Device: Advanced hybrid closed-loop CamAPS FX']}], 'interventions': [{'name': 'Advanced hybrid closed-loop CamAPS FX', 'type': 'DEVICE', 'otherNames': ['Ypsopump', 'CamAPS FX'], 'description': 'Treatment with a strict programmed glucose target (80-99 mg/dL).', 'armGroupLabels': ['Type 1 diabetes patients treated with AHCL (CamAPS-Ypsopump)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13005', 'city': 'Ciudad Real', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesús Moreno-Fernández, PhD', 'role': 'CONTACT', 'email': 'jmorenof@sescam.jccm.es', 'phone': '0034-926278000'}, {'name': 'Ignacio González Maroto', 'role': 'CONTACT', 'email': 'igmaroto@sescam.jccm.es', 'phone': '0034-926278000'}, {'name': 'Ignacio González Maroto', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jesús Moreno-Fernández, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pedro Rozas-Moreno, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mercedes Muñoz Martínez', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Antonia Horcajada', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Javier Gargallo Vaamonde', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manuel Delgado del Rey', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rita Virlaboa Cebrián', 'role': 'SUB_INVESTIGATOR'}, {'name': 'José de Toro Ruiz', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laura Morales Bruque', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ciudad Real General University Hospital', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}], 'centralContacts': [{'name': 'Ignacio González Maroto', 'role': 'CONTACT', 'email': 'igmaroto@sescam.jccm.es', 'phone': '0034-926278000'}, {'name': 'Jesus Moreno-Fernández', 'role': 'CONTACT', 'email': 'jmorenof@sescam.jccm.es', 'phone': '0034-926278000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'According to the requested data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Castilla-La Mancha Health Service', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}