Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:51 AM
Study NCT ID:
NCT07376850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-29
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007316', 'term': 'Insemination, Artificial, Heterologous'}], 'ancestors': [{'id': 'D007315', 'term': 'Insemination, Artificial'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007314', 'term': 'Insemination'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory endpoints', 'timeFrame': '12 months', 'description': 'Difference in the percentage of time in range (TIR) and time in normal glycemia (TING) at 3, 6, 9, and 12 months'}, {'measure': 'Exploratory endpoints', 'timeFrame': '12 months', 'description': 'Change in time in hypoglycemia level 1 (3,0-3,8 mmol/l) and level 2 (\\<3,0 mmol/l), hyperglycemia level 1 (10,1-13,9 mmol/l) and level 2 (\\>13,9 mmol/l) at 3, 6, 9, and 12 months'}, {'measure': 'Exploratory endpoints', 'timeFrame': '12 months', 'description': 'Change in Glycemic variability (SD, CV)'}, {'measure': 'Exploratory endpoint', 'timeFrame': '12 months', 'description': 'Change in Mean glucose level'}, {'measure': 'Exploratory endpoint', 'timeFrame': '12 months', 'description': 'Difference in Insulin dose'}, {'measure': 'Exploratory endpoint', 'timeFrame': '12 months', 'description': 'Change in HbA1c'}], 'primaryOutcomes': [{'measure': 'Primary Endpoint', 'timeFrame': '12 months', 'description': 'Change in TIR over 12 months (between M0 and M12) between TING and TIR groups'}], 'secondaryOutcomes': [{'measure': 'Diabetes-Related Emotional Distress in Pediatric Participants (PAID-Teen', 'timeFrame': 'At enrollment, 6 months and 12 months', 'description': 'A 20-item survey assessing emotional distress. Items are scored 0-4. Unit of Measure: Standardized score (Range: 0 to 100). Interpretation: Higher scores indicate higher distress.'}, {'measure': 'Participant Perceptions of Diabetes Technology - INSPIRE Patient Scale', 'timeFrame': 'At enrollment, 6 months and 12 months', 'description': 'QoL questionnaire: Assesses how young patients feel about their insulin delivery systems.\n\nUnit of Measure: Score on a scale (Range: 0 to 100). Higher scores indicate higher satisfaction and more positive expectations of the device.'}, {'measure': 'Quality of Life (QoL) Related to Diabetes Technology - INSPIRE Parent/Caregiver Scale', 'timeFrame': 'At enrollment, 6 months and 12 months', 'description': 'Assesses parent/caregiver perceptions of automated insulin delivery systems. Each item is scored 0-4.\n\nUnit of Measure: Score on a scale (Range: 0 to 100). Interpretation: Higher scores indicate a more positive appraisal of the technology and better QoL.'}, {'measure': 'Parent/Caregiver Fear of Hypoglycemia (HFS-P)', 'timeFrame': 'At enrollment, 6 months and 12 months', 'description': 'A 26-item survey with two subscales: Behavior (11 items) and Worry (15 items). Items are rated from 0 (never) to 4 (very often).\n\nUnit of Measure: Total score (Range: 0 to 104). Interpretation: Higher scores indicate a greater fear of hypoglycemia.'}, {'measure': 'Parent/Caregiver Fear and Behaviors Related to Hyperglycemia (HAQ)', 'timeFrame': 'At enrollment, 6 months and 12 months', 'description': 'QoL questionnaire: Measures the extent of potentially problematic attitudes and behaviors used to avoid high blood sugar. It consists of 22 items rated 0-4.\n\nUnit of Measure: Total score (Range: 0 to 88). Interpretation: Higher scores indicate greater levels of hyperglycemia-related worry and more frequent avoidance behaviors.'}, {'measure': 'Diabetes-Related Emotional Distress in Parents/Caregivers (PAID-PR)', 'timeFrame': 'At enrollment, 6 months and 12 months', 'description': 'A 18-item scale measuring the emotional burden of caregiving. Items are rated from 0 (no problem) to 4 (serious problem).\n\nUnit of Measure: Total score (Range: 0 to 72). Interpretation: Higher scores reflect greater diabetes-specific emotional distress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes (DM)', 'Diabetes Type 1']}, 'descriptionModule': {'briefSummary': 'The TANGO study is a 12-month study involving 120 children and adolescents with Type 1 Diabetes (T1D) across the Czech Republic, Israel, and Poland who use automated insulin delivery (AID) systems.\n\nCurrently, the global standard for diabetes management is "Time in Range" (TIR), which aims to keep blood sugar levels between 70-180 mg/dL. However, newer technologies like AID systems may now allow for a tighter, more physiological goal called "Time in Normal Glycemia" (TING), which targets a range of 70-140 mg/dL.\n\nThis study will randomly assign participants to follow either the standard TIR target or the tighter TING target to see if the narrower range improves overall blood sugar control and HbA1c without increasing the risk of hypoglycemia, family stress, or daily treatment burden.\n\nBy comparing these two approaches, researchers hope to determine if clinical guidelines should be updated to reflect a more precise glucose target for children and adolescents worldwide', 'detailedDescription': 'This multinational, multicenter, randomized controlled trial aims to evaluate the clinical impact of targeting Time in Normal Glycemia (TING; 70-140 mg/dL) compared to the current standard, Time in Range (TIR; 70-180 mg/dL), in children and adolescents with Type 1 Diabetes (T1D).\n\nBackground and Rationale Managing glucose levels in pediatric T1D is essential for preventing long-term complications. While the international consensus currently recommends maintaining a TIR \\>70%, recent technological advances-such as automated insulin delivery (AID) systems and next-generation continuous glucose monitors (CGM)-now make it feasible to target narrower, more physiological glucose ranges. TING (70-140 mg/dL) has emerged as a potential new clinical metric for improved metabolic compensation. However, there is no definitive evidence yet that aiming for this tighter range leads to better long-term outcomes than the standard TIR without increasing treatment burden or psychological stress.\n\nStudy Objectives The primary objective is to determine if setting TING as the glycemic target improves CGM-derived glycemic metrics compared to the standard TIR approach.\n\nSecondary objectives include:\n\nEvaluating changes in HbA1c. Assessing differences in Quality of Life (QoL) and treatment burden using standardized patient and caregiver questionnaires.\n\nMonitoring the safety and incidence of acute complications, such as severe hypoglycemia and diabetic ketoacidosis (DKA).\n\nStudy Design and Population The study will enroll 120 children and adolescents (ages 5.0-17.99) across three tertiary pediatric diabetes centers in the Czech Republic, Israel, and Poland. All participants must be using AID systems and have used a CGM for at least 70% of the time in the month prior to enrollment.\n\nFrom the target population, we aim to recruit 25% of individuals newly diagnosed.\n\nIntervention and Methods\n\nParticipants will be randomized 1:1 into two groups:\n\nTING Group (Intervention): Will follow a target glucose range of 70-140 mg/dL (3.9-7.8 mmol/L).\n\nTIR Group (Control): Will follow the standard target range of 70-180 mg/dL (3.9-10.0 mmol/L).\n\nBoth groups will receive structured education from a multidisciplinary team regarding CGM interpretation, glycemic targets, and self-management. In the TING group, CGM hyperglycemia targets will be lowered by at least 10% from baseline.\n\nTimeline and Endpoints The study duration is 12 months. Data collection includes CGM metrics, insulin dose data, and HbA1c at 3-month intervals (Months 0, 3, 6, 9, and 12). A telephone check-up will occur 6 weeks after baseline to assess early adherence and treatment satisfaction.\n\nPrimary Endpoint: Change in TIR (70-180 mg/dL) between baseline and 12 months.\n\nSecondary/Exploratory Endpoints: Percentage of time in TING, time in hypoglycemia (Levels 1 and 2), glycemic variability, and various QoL scores (PAID, INSPIRE, Hypoglycemia/Hyperglycemia Fear Surveys) .\n\nImpact If targeting TING is proven beneficial and acceptable, the results of this trial could inform future clinical guidelines and redefine optimal glycemic targets for pediatric diabetes care globally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of T1D per ADA criteria\n* Age 5.0-17.99 at the start of study\n* CGM use \\>70% of the time during the month prior to enrollment\n* Maximum HbA1c of 86mmol/mol (10% in DCCT)\n\nExclusion Criteria:\n\n* No concurrent illnesses impacting glycemia\n* No treatments impacting glycemia\n* Severe hypoglycemia documented in the 60 day period leading up to patient recruitment\n* Current participation in any other interventional study\n* Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise participant's safety\n* Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration"}, 'identificationModule': {'nctId': 'NCT07376850', 'acronym': 'TANGO', 'briefTitle': 'Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Motol'}, 'officialTitle': 'Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control', 'orgStudyIdInfo': {'id': 'TANGO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TIR group', 'description': 'Participants in this group will follow the current standard international clinical guidelines, targeting a glycemic range of 3.9-10.0 mmol/L (70-180 mg/dL). They will receive the same level of structured multidisciplinary education and clinical follow-up as the intervention group, but calibrated to the standard 70-180 mg/dL range.', 'interventionNames': ['Other: Structured Diabetes Education']}, {'type': 'EXPERIMENTAL', 'label': 'TING group', 'description': 'Participants in this group will target a tighter glycemic range of 3.9-7.8 mmol/L (70-140 mg/dL). Their CGM and insulin pump settings will be adjusted by their physician to support this narrower range. Participants will receive structured education focused on achieving this tighter target.', 'interventionNames': ['Other: Structured Diabetes Education', 'Other: Automated Insulin Delivery (AID) System Adjustment']}], 'interventions': [{'name': 'Structured Diabetes Education', 'type': 'OTHER', 'description': 'A comprehensive standardized guideline will be provided to recruiting physicians from all centers, including the points below:\n\n1. Understanding CGM data and trend interpretation\n2. TIR or TING concepts according to randomization, target range, consequences of hypoglycemia and hyperglycemia\n3. Recognizing and management of hypoglycemia\n4. Recognizing and management of hyperglycemia\n5. Setting and adjusting of glycemic targets, alarms in CGM and insulin pumps, and insulin doses based on randomisation\n6. Emotional coping strategies and involving family support', 'armGroupLabels': ['TING group', 'TIR group']}, {'name': 'Automated Insulin Delivery (AID) System Adjustment', 'type': 'OTHER', 'description': 'For the TING group, CGM hyperglycemia target settings will be lowered by at-least 10% from the baseline values. The extent of the adjustment will be at the discretion of the attending physician', 'armGroupLabels': ['TING group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Shenali Amaratunga', 'role': 'CONTACT', 'email': 'shenali.amaratunga@fnmotol.cz'}], 'facility': 'Motol University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center of Israel", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Warsaw', 'country': 'Poland', 'contacts': [{'name': 'Agnieszka Szypowska', 'role': 'CONTACT'}], 'facility': 'Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': "We plan to share the anonymised participants' data on individual request"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Motol', 'class': 'OTHER'}, 'collaborators': [{'name': "Schneider Children's Medical Center, Israel", 'class': 'OTHER'}, {'name': 'Medical University of Warsaw', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Zdeněk Šumník', 'investigatorAffiliation': 'University Hospital, Motol'}}}}