{"studies":[{"protocolSection":{"identificationModule":{"nctId":"NCT04275752","orgStudyIdInfo":{"id":"19-008545"},"secondaryIdInfos":[{"id":"K23DK123313-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/K23DK123313-01"}],"organization":{"fullName":"Mayo Clinic","class":"OTHER"},"briefTitle":"Exercise Intervention on Frailty After Kidney Transplantation","officialTitle":"Examining the Preliminary Efficacy, Feasibility, and Acceptability of an Exercise Intervention on Frailty After Kidney Transplantation"},"statusModule":{"statusVerifiedDate":"2022-04","overallStatus":"WITHDRAWN","whyStopped":"Original funding for this study changed and it is no longer being pursued","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-02-01","type":"ESTIMATED"},"primaryCompletionDateStruct":{"date":"2022-02-28","type":"ESTIMATED"},"completionDateStruct":{"date":"2022-05-30","type":"ESTIMATED"},"studyFirstSubmitDate":"2020-02-13","studyFirstSubmitQcDate":"2020-02-17","studyFirstPostDateStruct":{"date":"2020-02-19","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-04-07","lastUpdatePostDateStruct":{"date":"2022-04-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Elizabeth C. Lorenz","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Mayo Clinic"},"leadSponsor":{"name":"Mayo Clinic","class":"OTHER"},"collaborators":[{"name":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Researchers are trying to determine if exercise will improve health and strength in kidney transplant patients."},"conditionsModule":{"conditions":["Kidney Transplant"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"SUPPORTIVE_CARE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":0,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Usual Care Group","type":"NO_INTERVENTION","description":"Subjects will receive no formal exercise recommendations"},{"label":"Exercise Intervention Group","type":"EXPERIMENTAL","description":"Subjects will complete an exercise program","interventionNames":["Other: Exercise Program"]}],"interventions":[{"type":"OTHER","name":"Exercise Program","description":"Perform endurance (treadmill or cycle ergometer), strength (weight resistance), and flexibility training twice a week for a period of one hour per session, for a total of 16 sessions.","armGroupLabels":["Exercise Intervention Group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in frailty status","description":"Frailty will be determined by Frailty Phenotype (FP) or Short Physical Performance Battery (SPPB) scores. FP is determined by the presence of 3 or more of the following: slowness (measured by gait speed), exhaustion (measured via self-report), weakness (measured by hand grip strength), low physical activity level (measured via self-report), and wasting (measured via self-report or by tracking changes in weight). The SPPB consists of a gait speed test, balance testing, and repeated chair stands. A score less than or equal to 10 will be considered frail.","timeFrame":"Two months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients age ≥ 18 years who have received a KT and have a functioning allograft\n\nExclusion Criteria:\n\n* Neuropsychiatric condition causing patient to be unable to provide consent\n* Recipient of a combined organ transplant","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Elizabeth Lorenz, MD","affiliation":"Mayo Clinic","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","zip":"55905","country":"United States","geoPoint":{"lat":44.02163,"lon":-92.4699}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Mayo Clinic Clinical Trials","url":"https://www.mayo.edu/research/clinical-trials"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-09-15"},"interventionBrowseModule":{"meshes":[{"id":"D055070","term":"Resistance Training"}],"ancestors":[{"id":"D005081","term":"Exercise Therapy"},{"id":"D012046","term":"Rehabilitation"},{"id":"D000359","term":"Aftercare"},{"id":"D003266","term":"Continuity of Patient Care"},{"id":"D005791","term":"Patient Care"},{"id":"D013812","term":"Therapeutics"},{"id":"D026741","term":"Physical Therapy Modalities"},{"id":"D064797","term":"Physical Conditioning, Human"},{"id":"D015444","term":"Exercise"},{"id":"D009043","term":"Motor Activity"},{"id":"D009068","term":"Movement"},{"id":"D009142","term":"Musculoskeletal Physiological Phenomena"},{"id":"D055687","term":"Musculoskeletal and Neural Physiological Phenomena"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT07672652","orgStudyIdInfo":{"id":"2025-SAEK-0034"},"organization":{"fullName":"Izmir Katip Celebi University","class":"OTHER"},"briefTitle":"Effect of Type 2 Diabetes on Biomarker Levels in Albumin Platelet-Rich Fibrin","officialTitle":"Effect of Type 2 Diabetes on Insulin Like Growth Factor-1, Epidermal Growth Factor and Interleukin-6 Levels in Albumin Platelet-Rich Fibrin Membranes"},"statusModule":{"statusVerifiedDate":"2026-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2025-12-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2026-03-20","type":"ACTUAL"},"completionDateStruct":{"date":"2026-06-15","type":"ACTUAL"},"studyFirstSubmitDate":"2026-06-17","studyFirstSubmitQcDate":"2026-06-22","studyFirstPostDateStruct":{"date":"2026-06-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-06-27","lastUpdatePostDateStruct":{"date":"2026-07-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Aylin Gizem Altıntaş","investigatorTitle":"Research Assistant","investigatorAffiliation":"Izmir Katip Celebi University"},"leadSponsor":{"name":"Izmir Katip Celebi University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Diabetes mellitus is a metabolic disease that can negatively affect wound healing and tissue repair. Albumin platelet-rich fibrin (Alb-PRF) is a blood-derived biomaterial used in periodontal and regenerative treatments. It contains growth factors and cytokines that may support tissue healing.\n\nThe purpose of this study is to evaluate whether type 2 diabetes affects the biological composition of Alb-PRF. For this purpose, Alb-PRF samples obtained from individuals with type 2 diabetes will be compared with samples obtained from systemically healthy individuals.\n\nA total of 20 participants will be included in the study: 10 individuals with type 2 diabetes and 10 systemically healthy individuals. Venous blood samples will be collected from each participant, and Alb-PRF will be prepared using a standardized protocol. The prepared samples will be stored at -80°C until laboratory analysis.\n\nThe levels of interleukin-6 (IL-6), epidermal growth factor (EGF), and insulin-like growth factor-1 (IGF-1) in Alb-PRF samples will be measured using an enzyme-linked immunosorbent assay (ELISA). These markers are related to inflammation, tissue repair, and wound healing. The results will help determine whether type 2 diabetes changes the cytokine and growth factor profile of Alb-PRF."},"conditionsModule":{"conditions":["Healthy Participants","Diabetes Mellitus (Type 2)"],"keywords":["Alb-PRF","Diabetes Mellitus","Epidermal Growth Factor","Insulin Like Growth Factor-1","Interleukin-6","EGF","IGF-1","IL-6","Albumin Platelet Rich Fibrin"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Participants will be assigned to two parallel groups: individuals with type 2 diabetes and systemically healthy individuals. Alb-PRF samples obtained from both groups will be analyzed and compared in terms of IL-6, EGF, and IGF-1 levels.","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":20,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Type 2 Diabetes Group","type":"EXPERIMENTAL","description":"Participants with type 2 diabetes. Venous blood samples will be collected, and Alb-PRF samples will be prepared for the measurement of IL-6, EGF, and IGF-1 levels.","interventionNames":["Procedure: Venous blood sampling and Alb-PRF preparation"]},{"label":"Systemically Healthy Group","type":"EXPERIMENTAL","description":"Systemically healthy participants without type 2 diabetes. Venous blood samples will be collected, and Alb-PRF samples will be prepared for the measurement of IL-6, EGF, and IGF-1 levels.","interventionNames":["Procedure: Venous blood sampling and Alb-PRF preparation"]}],"interventions":[{"type":"PROCEDURE","name":"Venous blood sampling and Alb-PRF preparation","description":"Venous blood samples will be collected from participants. Alb-PRF samples will be prepared using a standardized protocol, and IL-6, EGF, and IGF-1 levels will be measured using ELISA.","armGroupLabels":["Systemically Healthy Group","Type 2 Diabetes Group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"IL-6 Levels in Alb-PRF samples","description":"Interleukin-6 (IL-6) levels will be measured in Alb-PRF samples obtained from participants using ELISA.","timeFrame":"Baseline (Day 1)"},{"measure":"EGF level in Alb-PRF samples","description":"Epidermal growth factor (EGF) levels will be measured in Alb-PRF samples obtained from participants using ELISA.","timeFrame":"Baseline (Day 1)"},{"measure":"IGF-1 level in Alb-PRF samples","description":"Insulin-like growth factor-1 (IGF-1) levels will be measured in Alb-PRF samples obtained from participants using ELISA.","timeFrame":"Baseline (Day 1)"}],"secondaryOutcomes":[{"measure":"Correlation between age and IL-6 concentration in Alb-PRF samples","description":"Correlation between age (years) and IL-6 concentration (pg/mL) in Alb-PRF samples measured using ELISA.","timeFrame":"Baseline (Day 1)"},{"measure":"Correlation between age and EGF concentration in Alb-PRF samples","description":"Correlation between age (years) and EGF concentration (pg/mL) in Alb-PRF samples measured using ELISA.","timeFrame":"Baseline (Day 1)"},{"measure":"Correlation between age and IGF-1 concentration in Alb-PRF samples","description":"Correlation between age (years) and IGF-1 concentration (pg/mL) in Alb-PRF samples measured using ELISA.","timeFrame":"Baseline (Day 1)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\nFor the type 2 diabetes group:\n\n* Diagnosis of type 2 diabetes\n* HbA1c value of at least 7%\n* Age over 18 years\n* Non-smoker\n* No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the last 6 months\n* Not pregnant or lactating\n* Willingness to participate in the study and signing of the informed consent form\n\nFor the systemically healthy group:\n\n* No history of diabetes or prediabetes\n* Age over 18 years\n* Non-smoker\n* No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the last 6 months\n* Not pregnant or lactating\n* Willingness to participate in the study and signing of the informed consent form\n\nExclusion Criteria:\n\n* Age under 18 years\n* Pregnancy or lactation\n* Use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the last 6 months\n* Smoking\n* Refusal to participate in the study or not signing the informed consent form","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"İzmir Katip Çelebi University","city":"Izmir","state":"Cigli","zip":"35620","country":"Turkey (Türkiye)","geoPoint":{"lat":38.41273,"lon":27.13838}}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Individual participant data will not be shared due to privacy and ethical restrictions."}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-09-15"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"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"}]},"interventionBrowseModule":{"meshes":[{"id":"D001800","term":"Blood Specimen Collection"}],"ancestors":[{"id":"D013048","term":"Specimen Handling"},{"id":"D019411","term":"Clinical Laboratory Techniques"},{"id":"D019937","term":"Diagnostic Techniques and Procedures"},{"id":"D003933","term":"Diagnosis"},{"id":"D011677","term":"Punctures"},{"id":"D013514","term":"Surgical Procedures, Operative"},{"id":"D008919","term":"Investigative Techniques"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT05411952","orgStudyIdInfo":{"id":"Hasan-Kalyoncu-UnivHulyaYilmaz"},"organization":{"fullName":"Hasan Kalyoncu University","class":"OTHER"},"briefTitle":"Family-Based Behavioral Medical Nutrition Therapy Education in Children and Adolescents With Type 1 Diabetes","officialTitle":"The Effect of Family-Based Behavioral Medical Nutrition Therapy Education on Nutritional Status and Metabolic Control in Children and Adolescents With Type 1 Diabetes"},"statusModule":{"statusVerifiedDate":"2022-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-08-13","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-01-28","type":"ACTUAL"},"completionDateStruct":{"date":"2021-09-15","type":"ACTUAL"},"studyFirstSubmitDate":"2022-05-30","studyFirstSubmitQcDate":"2022-06-06","studyFirstPostDateStruct":{"date":"2022-06-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-06-06","lastUpdatePostDateStruct":{"date":"2022-06-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Hulya Yilmaz","investigatorTitle":"Research Assistant","investigatorAffiliation":"Hasan Kalyoncu University"},"leadSponsor":{"name":"Hasan Kalyoncu University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Type 1 Diabetes Mellitus (T1DM) is a heterogeneous condition and is an absolute insulin deficiency resulting from autoimmune-mediated destruction of pancreatic β-cells (1). The incidence of T1DM has been increasing globally since the 1950s, particularly in children, with an average annual increase of 3-4% over the past three decades.Despite the advances in medical treatment and technology, nutritional therapy continues to be the main component of diabetes treatment. Medical nutrition further improves metabolic control outcomes when T1DM care is combined with other treatments.This study was conducted to examine the effect of family-based behavioral medical nutrition therapy training on nutritional status and metabolic control in children and adolescents with Type 1 diabetes.","detailedDescription":"The research was carried out with children and adolescents aged 8-18 years who were followed up with the diagnosis of Type 1 Diabetes Mellitus in Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. The sample of the study was consisted of 75 (male= 36, female= 39) children and adolescents in total, including Intervention 1 group (n=25), Intervention 2 (n=25) group and Control (n=25) group determined by double-blind, stratified, random method. Medical nutrition therapy and carbohydrate counting training were given to mothers and children in the Intervention 1 group, and only to children and adolescents in the Intervention 2 group. The control group did not receive medical nutrition therapy and carbohydrate counting training. At the beginning (0. month) and at the end (6. month) of the study, 3 consecutive day/24-hour food consumption records and anthropometric measurements of the individuals were assessed, BMI z-scores and height z-scores were calculated, Mediterranean Diet Quality Index Scale (KIDMED), Diabetes Eating Problems Survey-Revised (DEPS-R), Physical Activity Questionnaire for Children and Adolescents (PAQ-C and PAQ-A) were administered and Healthy Eating Index 2015 (HEI-2015) scores were calculated. Routinely assessed blood findings of the individuals were checked at the beginning (0. month), 3rd month and 6th month of the study."},"conditionsModule":{"conditions":["Type1diabetes"],"keywords":["Type 1 diabetes, nutrition education, metabolic control"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"The sample of the study was consisted of 75 (male= 36, female= 39) children and adolescents in total, including Intervention 1 group (n=25), Intervention 2 (n=25) group and Control (n=25) group determined by double-blind, stratified, random method.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":75,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"education-mother and child dyad","type":"EXPERIMENTAL","description":"Mother and child dyad have received dietary intervention for 6 months","interventionNames":["Other: Medical nutrition therapy and carbohydrate counting education"]},{"label":"education-only child","type":"EXPERIMENTAL","description":"Children have received dietary intervention for 6 months. But their mothers didn't receive any dietary intervention","interventionNames":["Other: Medical nutrition therapy and carbohydrate counting education"]},{"label":"control","type":"EXPERIMENTAL","description":"Control group did't receive any dietary intervention during the study","interventionNames":["Other: No intervention"]}],"interventions":[{"type":"OTHER","name":"Medical nutrition therapy and carbohydrate counting education","description":"Children and their mothers have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian","armGroupLabels":["education-mother and child dyad"]},{"type":"OTHER","name":"Medical nutrition therapy and carbohydrate counting education","description":"Only children have received family-based behavioral medical nutrition therapy and carbohydrate counting education for 6 months by trained dietitian","armGroupLabels":["education-only child"]},{"type":"OTHER","name":"No intervention","description":"Control group didn't receive any intervention by trained dietitian. Furthermore they continued their routine health controls.","armGroupLabels":["control"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in mean of HbA1c from baseline to 6 months","description":"All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p\\< 0.05","timeFrame":"6 months"}],"secondaryOutcomes":[{"measure":"Change in mean of Healthy Eating Index 2015 (HEI-2015) score from baseline to 6 Months","description":"All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p\\< 0.05","timeFrame":"6 months"},{"measure":"Change in mean of Mediterranean Diet Quality Index Scale (KIDMED) from baseline to 6 Months","description":"All data were analysed by using IBM SPSS Statistics 26 and significance was defined as p\\< 0.05","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 8-18 years old,\n* Being diagnosed with T1DM for at least ≥1 year, maximum ≤5 years,\n* Latest HbA1c ≥6.5% - \\<13.5%,\n* Receiving intensive insulin therapy (at least 3 times a day bolus and 1 time basal insulin administration or using an insulin pump),\n* No communication problems\n* Children and adolescents without any other disease accompanying diabetes were included in the study.\n\nExclusion Criteria:\n\n* Celiac, cystic fibrosis etc. with gastrointestinal diseases,\n* Using any drug that may affect glucose metabolism,\n* Switched from an insulin pen to an insulin pump in less than 6 months,\n* Involved in any other intervention work in the last 6 months,\n* and individuals with communication problems were not included in the study.","healthyVolunteers":false,"sex":"ALL","minimumAge":"8 Years","maximumAge":"18 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Gulden KOKSAL, Prof.","affiliation":"Hasan Kalyoncu University","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Gaziantep Cengiz Gokcek Gynecology and Pediatrics Hospital","city":"Gaziantep","zip":"27010","country":"Turkey (Türkiye)","geoPoint":{"lat":37.05944,"lon":37.3825}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-09-15"},"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":"D044623","term":"Nutrition Therapy"}],"ancestors":[{"id":"D013812","term":"Therapeutics"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT02696252","orgStudyIdInfo":{"id":"PTL-901800"},"organization":{"fullName":"DexCom, Inc.","class":"INDUSTRY"},"briefTitle":"G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator","officialTitle":"Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator"},"statusModule":{"statusVerifiedDate":"2016-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-01"},"primaryCompletionDateStruct":{"date":"2016-04","type":"ACTUAL"},"completionDateStruct":{"date":"2016-04","type":"ACTUAL"},"studyFirstSubmitDate":"2016-01-25","studyFirstSubmitQcDate":"2016-02-25","studyFirstPostDateStruct":{"date":"2016-03-02","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-04-13","lastUpdatePostDateStruct":{"date":"2016-04-14","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"DexCom, Inc.","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator","detailedDescription":"The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator."},"conditionsModule":{"conditions":["Diabetes Mellitus"],"keywords":["Endocrine System Diseases","Glucose Metabolism Disorders","Metabolic Diseases"]},"designModule":{"studyType":"OBSERVATIONAL","patientRegistry":false,"designInfo":{"observationalModel":"COHORT","timePerspective":"PROSPECTIVE"},"enrollmentInfo":{"count":97,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"CGM Users"}]},"outcomesModule":{"primaryOutcomes":[{"measure":"proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL","timeFrame":"7 days"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Ages 2 or older\n* Diagnosis of Type 1 diabetes or Type 2 diabetes\n* Willing to participate in a clinic session involving venous sampling for evaluation of study end point\n\nExclusion Criteria:\n\n* Use of acetaminophen\n* Known allergy to medical-grade adhesives\n* Pregnancy\n* Hematocrit outside specification of the study-assigned blood glucose meter","healthyVolunteers":false,"sex":"ALL","minimumAge":"2 Years","stdAges":["CHILD","ADULT","OLDER_ADULT"],"studyPopulation":"Adults and pediatrics with diabetes mellitus","samplingMethod":"NON_PROBABILITY_SAMPLE"},"contactsLocationsModule":{"locations":[{"facility":"AMCR Institute","city":"Escondido","state":"California","zip":"92025","country":"United States","geoPoint":{"lat":33.11921,"lon":-117.08642}},{"facility":"Rocky Mountain Diabetes and Osteoporosis Center","city":"Idaho Falls","state":"Idaho","zip":"83404","country":"United States","geoPoint":{"lat":43.46658,"lon":-112.03414}},{"facility":"Joslin Diabetes Center","city":"Boston","state":"Massachusetts","zip":"02215","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"Clinical Trials of Texas","city":"San Antonio","state":"Texas","zip":"78229","country":"United States","geoPoint":{"lat":29.42412,"lon":-98.49363}}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-09-15"},"conditionBrowseModule":{"meshes":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"}],"ancestors":[{"id":"D009750","term":"Nutritional and Metabolic Diseases"}]}},"hasResults":false},{"protocolSection":{"identificationModule":{"nctId":"NCT02111226","orgStudyIdInfo":{"id":"182-2013"},"organization":{"fullName":"Sunnybrook Health Sciences Centre","class":"OTHER"},"briefTitle":"Detecting and Treating High Blood Pressure in Aboriginal Population and Low and Middle Income Countries","officialTitle":"DREAM-GLOBAL: Diagnosing hypeRtension - Engaging Action and Management in Getting LOwer Bp in Aboriginal and LMIC - A Research Proposal","acronym":"DREAM-GLOBAL"},"statusModule":{"statusVerifiedDate":"2017-07","overallStatus":"UNKNOWN","lastKnownStatus":"RECRUITING","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-01"},"primaryCompletionDateStruct":{"date":"2018-01","type":"ESTIMATED"},"completionDateStruct":{"date":"2018-03","type":"ESTIMATED"},"studyFirstSubmitDate":"2014-03-13","studyFirstSubmitQcDate":"2014-04-08","studyFirstPostDateStruct":{"date":"2014-04-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-07-13","lastUpdatePostDateStruct":{"date":"2017-07-17","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Sheldon Tobe","investigatorTitle":"Principal Investigator - Medical Doctor","investigatorAffiliation":"Sunnybrook Health Sciences Centre"},"leadSponsor":{"name":"Sunnybrook Health Sciences Centre","class":"OTHER"},"collaborators":[{"name":"Canadian Institutes of Health Research (CIHR)","class":"OTHER_GOV"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Heart disease and stroke are the number one killers world-wide. When someone has hypertension, the constantly elevated blood pressure damages their blood vessels and the organs that they supply blood to. This causes stroke, heart attack, heart failure, kidney failure and dementia. Finding and lowering high blood pressure to normal with lifestyle changes and if necessary medications, lowers the risk of these outcomes. Canada has high rates of blood pressure control compared to other countries in the world, due in large part to the successful dissemination of hypertension guidelines. However remote and disadvantaged communities have not been as successful and need additional measures to help achieve the same level of blood pressure control as the rest of the country. The DREAM-GLOBAL team has extensive experience working with Canada's Aboriginal Communities and a large community in Tanzania. The DREAM-GLOBAL project will integrate innovations in technology with the implementation of guidelines-based blood pressure control and through partnerships with experts in government and industry, overcome barriers to lowering blood pressure in Canada's Aboriginal Communities, and in a community in Tanzania. Tools will be developed and tested that will close the circle of care around people with hypertension by bringing measurement data to the medical record and health care provider and also sending useful medical feedback to the person with hypertension via secure data servers and routine SMS messaging on cell phones. The system will be tested for effectiveness of diagnosing and also for managing hypertension. To begin the process of preventing hypertension, the team will also explore with an Aboriginal community how to create policies to reduce the sodium content in their food. If proven effective, DREAM-GLOBAL can also become a platform for managing other chronic diseases."},"conditionsModule":{"conditions":["Hypertension","Cardiovascular Disease","Diabetes"],"keywords":["hypertension","cardiovascular disease","diabetes","chronic disease management"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":360,"type":"ESTIMATED"}},"armsInterventionsModule":{"armGroups":[{"label":"Passive SMS Group","type":"ACTIVE_COMPARATOR","description":"Passive SMS messages focused on lifestyle adjustment","interventionNames":["Other: SMS text messaging"]},{"label":"Active SMS Group","type":"EXPERIMENTAL","description":"Active SMS messages based on hypertension clinical practice guidelines including rational for taking antihypertensive medication and reminders to see the health care practioner if BP is above target.","interventionNames":["Other: SMS text messaging"]}],"interventions":[{"type":"OTHER","name":"SMS text messaging","description":"short message service","armGroupLabels":["Active SMS Group","Passive SMS Group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Blood Pressure","description":"The change in blood pressure (systolic and diastolic) from baseline to the final BP measurement period","timeFrame":"one year"}],"secondaryOutcomes":[{"measure":"Blood Pressure","description":"The proportion of patients achieving BP control during the study period.","timeFrame":"one year"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age 18 years or older\n* Hypertension\n* BP \\> 140/90 mmHg or \\> 130/80 mmHg if patient has diabetes at the initial screening visit using an approved automated BP monitor.\n* If on drug therapy, continuous drug therapy with the same dosing interval for 8 weeks prior to and throughout the screening period. May be drug naive.\n* Written informed consent\n* Hypertension for at least 12 weeks before screening and throughout the screening period (according to the patient or their medical practitioner)\n* Must have a cell phone plan (in Canada) and be willing to maintain the plan during the study. For Tanzania, must have a cell phone under a locally available Tanzanian carrier.\n* Must be willing to take occasional local calls from study team members\n* One or more of BMI \\> 30 kg/m2, diabetes, smoking, over age 40, previous history of CAD including stroke and heart attack\n* An identified health care provider in the community (ie. Family Physician/Nurse Practitioner in Canada or Community Nurse/Clinical officer in Tanzania)\n\nExclusion Criteria:\n\n* Change in antihypertensive medication during the 8 weeks before enrolment\n* No cell phone plan compatible with the study.\n* Poorly controlled hypertension with BP \\> 180/110 mmHg\n* No primary health care provider\n* Active malignant disease (except non-melanoma skin cancer)\n* Unable or unwilling to visit health care provider\n* Unable to read the SMS messages (English in Canada and Kiswahili in Tanzania)\n* Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.\n* Planned elective surgery during the study period except for cataract surgery\n* \\*For BP screening study, must not be on an antihypertensive in the last 6 months.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"90 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"centralContacts":[{"name":"Diane Hua, MPH","role":"CONTACT","phone":"416-480-6100","phoneExt":"2186","email":"diane.hua@sunnybrook.ca"}],"overallOfficials":[{"name":"Sheldon W Tobe, MD, MScCH (HPTE), FRCPC, FACP,","affiliation":"Sunnybrook Health Sciences Centre, University of Toronto","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Karen E Yeates, MD, FRCP(C), MPH","affiliation":"Queen's University","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Norman RC Campbell, MD, FRCPC","affiliation":"University of Calgary","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Peter Liu, MD","affiliation":"Ottawa Heart Institute Research Corporation","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Sunnybrook Health Sciences Centre","status":"RECRUITING","city":"Toronto","state":"Ontario","zip":"M4N3M5","country":"Canada","contacts":[{"name":"Nancy Perkins","role":"CONTACT","phone":"416-480-6100","phoneExt":"7064","email":"dream.global@sunnybrook.ca"},{"name":"Sheldon W Tobe, MD","role":"PRINCIPAL_INVESTIGATOR"}],"geoPoint":{"lat":43.70643,"lon":-79.39864}}]},"referencesModule":{"references":[{"pmid":"31815678","type":"DERIVED","citation":"Barsky J, Hunter R, McAllister C, Yeates K, Campbell N, Liu P, Perkins N, Hua-Stewart D, Maar MA, Tobe SW. Analysis of the Implementation, User Perspectives, and Feedback From a Mobile Health Intervention for Individuals Living With Hypertension (DREAM-GLOBAL): Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Dec 9;7(12):e12639. doi: 10.2196/12639."},{"pmid":"31682574","type":"DERIVED","citation":"Maar MA, Beaudin V, Yeates K, Boesch L, Liu P, Madjedi K, Perkins N, Hua-Stewart D, Beaudin F, Wabano MJ, Tobe SW. Wise Practices for Cultural Safety in Electronic Health Research and Clinical Trials With Indigenous People: Secondary Analysis of a Randomized Clinical Trial. J Med Internet Res. 2019 Nov 4;21(11):e14203. doi: 10.2196/14203."},{"pmid":"30474909","type":"DERIVED","citation":"Tobe SW, Yeates K, Campbell NRC, Maar MA, Perkins N, Liu PP, Sleeth J, McAllister C, Hua-Stewart D, Wells G, Bernick J. Diagnosing hypertension in Indigenous Canadians (DREAM-GLOBAL): A randomized controlled trial to compare the effectiveness of short message service messaging for management of hypertension: Main results. J Clin Hypertens (Greenwich). 2019 Jan;21(1):29-36. doi: 10.1111/jch.13434. Epub 2018 Nov 26."},{"pmid":"29258978","type":"DERIVED","citation":"Yeates K, Campbell N, Maar MA, Perkins N, Liu P, Sleeth J, Smith C, McAllister C, Hua-Stewart D, Wells G, Tobe SW. The Effectiveness of Text Messaging for Detection and Management of Hypertension in Indigenous People in Canada: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 19;6(12):e244. doi: 10.2196/resprot.7139."},{"pmid":"28428165","type":"DERIVED","citation":"Maar MA, Yeates K, Perkins N, Boesch L, Hua-Stewart D, Liu P, Sleeth J, Tobe SW. A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings. JMIR Mhealth Uhealth. 2017 Apr 20;5(4):e47. doi: 10.2196/mhealth.7044."}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-09-15"},"conditionBrowseModule":{"meshes":[{"id":"D006973","term":"Hypertension"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D003920","term":"Diabetes Mellitus"}],"ancestors":[{"id":"D014652","term":"Vascular Diseases"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]}},"hasResults":false}],"nextPageToken":"ZVNj7o2Elu8o3lpwDt-y6unumpOQJJxrYfep"}