Projects | JCHR

Full public datasets are available on our Diabetes Public Datasets page.

RESEARCH HIGHLIGHTS

Primary results from the 2IQP study were published in the New England Journal of Medicine. A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes evaluated the use of the Control-IQ+ system in participants with type 2 diabetes.

Extenson phase results from the INHALE-3 study were recently published in Diabetes Technology and Therapeutics. A 13-Week Single-Arm Evaluation of Inhaled Technosphere Insulin Plus Inuslin Degludec for Adults with Type 1 Diabetes and Inhaled Technosphere Insulin Plus Insulin Degludec for Adults with Type 1 Diabetes: The Inhale-3 Extension Study examine the use of inhaled insulin compared to rapid-acting insulin analogs.

ACTIVE STUDIES

A Randomized Crossover Trial Evaluating the Effect of Inhaled Technosphere Insulin (Afrezza) versus Rapid Acting Analogue Insulin on Exercise-Induced Hypoglycemia in Adults with Type 1 Diabetes Using Automated Insulin Delivery (INHALE-AIDEx); NCT06880835
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes (CLVer): Extension Study (CLVerEx); NCT06177691
Inhaled Insulin vs. Rapid-Acting Injections for Post-Meal Glucose Control in Women with Gestational Diabetes (INHALE-GDM); NCT06535789
T1D Pregnancy & Me - Pregnancy Data Repository to Assess Management of Type 1 Diabetes with Diabetes Technology (PRAM-T1D); NCT06959316
Twiist-T2D: A Single Arm Trial with an Innovative Automated Inuslin Delivery System for Type 2 Diabetes; NCT06853990

COMPLETED STUDIES

A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes Continuous Glucose Monitoring Study; NCT02017171
A Pivotal Study of t:slim X2 with Control-IQ Technology; NCT03844789
- A Pivotal Study of t:slim X2 with Control-IQ Technology - Extension Study
A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes; NCT02985866
A Randomized Clinical Trial to Assess the Efficacy of Predictive Low Glucose Suspend Versus Sensor-augmented Pump Therapy in the Management of Type 1 Diabetes; NCT03195140
A Randomized, Placebo-controlled, Double-blinded Cross-over Study of the Pharmacologic Action of a GPR119 Agonist on Glucagon Counter-regulation during Insulin-induced Hypoglycemia in Type 1 Diabetes Mellitus; NCT04432090
A Randomized Trial Evaluating Control-IQ Technology in Adults with Type 2 Diabetes (2IQP); NCT05785832
A Randomized Trial to Assess the Effect of Continuous Glucose Monitoring on Glycemic Control in Adults with Type 1 Diabetes Using Injections for Insulin Delivery; NCT02282397
A Randomized Trial to Assess the Effect of Continuous Glucose Monitoring vs Usual Care in Type 2 Diabetes Patients on Multiple Daily Insulin Injections; NCT02282397
A Randomized Trial to Assess the Effect of Initiating an Insulin Pump in Adults with Type 1 Diabetes Using Multiple Daily Insulin Injections and Continuous Glucose Monitoring; NCT02282397
A Study of t:Slim X2 with Control-IQ Technology in Youth with Type 1 Diabetes; NCT03844789
A Validation Study of Home Blood Collection for HbA1c Measurement
An Observational Study of Adults with Type 3 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System (Loop T2D Observational) Study; NCT05951569
An Observational Study of Individuals with Type 1 Diabetes Using the Loop System for Automated Insulin Delivery
AIDING - Automated Insulin Delivery for Inpatients with Dysglycemia Feasibility Study; NCT04714216
Automated Insulin Delivery among Pregnant Women with Type 1 Diabetes (AiDAPT); NCT04938557
Automated Insulin Delivery in Elderly with T1D (AIDE T1D); NCT04016662
Closed Loop from Onset in type 1 Diabetes; NCT02871089
Closing the Loop in Adults with Type 1 Diabetes under Free Living Conditions with Extension to Evaluate Home Use of Closed-Loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart; NCT04055480
Closing the Loop in Children and Adolescents with T1D in the Home Setting; NCT01778348
Control-IQ Technology in Individuals with Type 2 Diabetes; NCT05111301
Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes CGM Data Management Center; NCT01788527
Continuous Glucose Monitoring in T2D Basal Insulin Users; NCT03566693
Day-and-Night Home Closed-Loop in Young People with Type 1 Diabetes; <ahref="https://clinicaltrials.gov/ct2/show/NCT02925299">NCT02925299
Direct to Patient Initiation of CGM in Diabetes
Evaluation of Modified Adhesives with Dexcom G6 Sensors in Individuals with Known G6 Adhesive Reactions (DEXAS); NCT04840446
Feasibility Assessment of Prototype Nocturnal Hypoglycemia Reduction System
Glycemic Variability and Fluctuations in Cognitive Status in Adults with Type 1 Diabetes (GluCog)
Home Testing of Day and Night Closed Loop with Pump Suspend Feature; NCT02523131
Hybrid Closed Loop and Verapamil for Beta Cell Preservation in New Onsets with T1D (CLVer); NCT04233034
In Home Closed Loop Reduction of Nocturnal Hypoglycemia and Daytime Hyperglycemia (IHCL) - datasets available on JDRF Public Website
INHALE-1 - A 26-week Primary Treatment Phase, with 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza versus Rapid-Acting Insulin Analog Injections, Both in Combination with a Basal Insulin, in Pediatric Subjects with Type 1 or Type 2 Diabetes Mellitus; NCT04974528
INHALE-3 - Afrezza Combined with Insulin Degludec versus Usual Care in Adults with Type 1 Diabetes; NCT05904743
Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System; NCT01271023
JDRF Artifical Pancreas Project
JDRF Continuous Glucose Monitoring (JDRF CGM RCT) - Public Dataset
Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set during Home Use in People with Type 1 Diabetes (CB1); NCT06273124
OP5-005 Using Omnipod 5 in Adults with Type 2 (SECURE-T2D); NCT05815342
Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children; NCT01823341
PID vs PID + Fuzzy Logic Crossover Study in Adolescents and Young Adults with Type 1 Diabetes; NCT03040414
Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use; NCT02137512
Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System: The Bigfoot Unity Real World Study (BURST); NCT05088265
Pump Suspension with Hyperglycemia Minimization Nocturnal Inpatient Safety and Feasibility Study
Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing;NCT02438189
Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents; NCT02714972
Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension: An Outpatient Pilot Feasibility and Efficacy Study; NCT01823341
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev with the Tandem t:slim X2 with Control-IQ in Adults, Adolescents, and Children with Type 1 Diabetes; NCT05403502
The Artificial Pancreas in the Very Young Children with T1D – Pilot Study; NCT03101865
The Artificial Pancreas in Very Young Children with T1D; NCT03784027
The International Diabetes Closed Loop Trial: A Randomized Crossover Comparison of Adaptive Model Predictive Control Artificial Pancreas Versus Sensor Augmented Pump/Predictive Low Glucose Suspend (PLGS) in the Outpatient Setting in Type 1 Diabetes; NCT04436769
The Insulin-Only Bionic Pancreas Bridging Study
The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children with Type 1 Diabetes (Full protocol available here); NCT04200313
- The Insulin-Only Bionic Pancreas Extension Study (Full protocol available here)
The Pediatric Artificial Pancreas trial: A Randomized Controlled Comparison of the Control-IQ technology Versus Standard of Care in Young Children in Type 1 Diabetes; NCT04796779
The Pediatric Artificial Pancreas Autormated Initialization Trial (PEDAP-AI); NCT06017089
Treat-to-Range Controller: Meal Assessment
Type 1 Diabetes Exercise Initiative: The Effect of Exercise on Glycemic Control in Type 1 Diabetes Pilot Study
Type 1 Diabetes Exercise Initiative: The Effect of Exercise on Glycemic Control in Type 1 Diabetes Study (Full protocol available here)
Type 1 Diabetes Exercise Initiative Pediatric Study: The Effect of Exercise on Glycemic Control in Youth with Type 1 Diabetes; Public Website (Full protocol available here
Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring; NCT04765358

T1D Exchange Clinic Network Studies

A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults with Type 1 Diabetes; NCT02258373
A Study to Assess Continuous Glucose Sensor Profiles in Healthy Non-Diabetic Subjects
Assessment of Intranasal Glucagon in Children and Adolescents with Type 1 Diabetes; NCT01997411
Beta Cell Function and Glucose Counter-Regulation During the Progression of Type 1 Diabetes
Efficacy and Safety of Intranasal Glucagon for Treatment of Insulin Induced Hypoglycemia in Adults with Diabetes; NCT01994746
Hybrid Closed Loop Insulin Delivery System Data Collection
Improving Family Management and Glycemic Control in Youth
Metformin Therapy for Overweight Adolescents with T1D: A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents with Type 1 Diabetes; NCT01881828
Metformin Therapy for Overweight Adolescents with T1D: Insulin Clamp Ancillary Study for Assessment of Insulin Resistance; NCT02045290
Mini-Dose Glucagon for Adults with Type 1 Diabetes: A Study to Assess the Efficacy and Safety of Mini-Dose Glucagon for Treatment of Non-Severe Hypoglycemia in Adults with Type 1 Diabetes; NCT02411578
Racial Differences in Mean CGM Glucose in Relation to HbA1c
Residual C-Peptide in Patients with Type 1 Diabetes
Severe Hypoglycemia in Older Adults with Type 1 Diabetes: A Study to Identify Factors Associated with the Occurrence of Severe Hypoglycemia in Older Adults with T1D
Strategies to Enhance New CGM Use in Early Childhood: A Randomized Clinical Trial Assessing Continuous Glucose Monitoring Alone and Combined with a Behavioral Intervention in Youth less than 8 Years of Age with Type 1 Diabetes; NCT02912728
The Use of Mini-Dose Glucagon to Prevent Exercise-Induced Hypoglycemia in Type 1 Diabetes; NCT02660242
Wireless Innovation for Seniors with Diabetes Mellitus: A Randomized Clinical Trial Assessing Continuous Glucose Monitoring in Older Adults with Type 1 Diabetes; NCT03240432

Diabetes Research in Children Network (DIRECNET) Studies

A Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children; NCT00069602
A Pilot Study to Assess the Feasibility of Real-Time Continuous Glucose Monitoring in the Management of Infants and Toddlers with Type 1 Diabetes
A Pilot Study to Evaluate the GlucoWatch 2 Biographer in the Management of Type 1 Diabetes in Children; NCT00069615
A Pilot Study to Evaluate the Navigator Continuous Glucose Sensor in the Management of Type 1 Diabetes in Children
A Pilot Study to Evaluate the Safety of Terbutaline in Children with Type 1 Diabetes; NCT00607503
A Randomized Trial to Assess the Effectiveness of the GlucoWatch Biographer in the Management of Type 1 Diabetes in Children; NCT00069628
A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds); NCT00760526
Cognitive and Neuroanatomical Consequences of Type 1 Diabetes in Young Children
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes; NCT00891995
Evaluation of Counter-regulatory Hormone Responses during Hypoglycemia and the Accuracy of Continuous Glucose Monitors in Children with T1DM; NCT00607139
Relationship Between Loss of Beta Cell Function and Loss of the Alpha Cell Response to Hypoglycemia Early in Type 1 Diabetes
The Accuracy of Continuous Glucose Monitors in Children with Type 1 Diabetes; NCT00069537
The Effect of Basal Insulin During Exercise on the Development of Hypoglycemia in Children with Type 1 Diabetes; NCT00147342
The Effect of Exercise on the Development of Hypoglycemia in Children with Type 1 Diabetes

RESEARCH HIGHLIGHTS

Primary results from the CALEC study were published in Nature Communications. Cultivated Autologous Limbal Epithelial Cell (CALEC) Transplatation for Limbal Stem Cell Deficiency: A Phase I/II Clinical Trial of the First Xenobiotic-Free, Serum-Free, Antiboiotic-Free Manufacturing Protocol Developed in the US describes the feasiblity and safety of a novel stem cell manufacturing process.

The latest results from the Federation Fighting Blindness Clinical Consortium were published in Translational Vision Science & Technology in October 2024 with Dr. Maureen Maguire as lead author; Endpoints and Design for Clinical Trials in USH2A-related Retinal Degeneration: Results from the RUSH2A Natural History Study.

The latest data from DRCR were published in Translational Vision Science & Technology in July 2024 with Dr. Brian Lee as lead author on the Long-term Effects of Intravitreal Ranibizumab Compared with Panretinal Photocoagulation on Optical Coherence Tomography Measured Choroidal Thickness and Vascularity manuscript

ACTIVE STUDIES

Diabetes Endothelial Keratoplasty Study (DEKS)

Impact of Diabetes on Corneal Transplant Success and Endothelial Cell Loss; NCT05134480

DRCR Retina Network

Facilitating multicenter clinical research of diabetic retinopathy, age related macular degeneration and other retinal disorders.

DRCR Retina Network Public Website

A Randomized Trial Comparing Immediate versus Deferred Surgery for Symptomatic Epiretinal Membranes (Protocol AM)
A Randomized Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening (Protocol AF)
A Phase 2 Study Evaluating Short-Term Efficacy of Tonabersat for Diabetic Macular Edema (Protocol AN)
Randomized Clinical Trial Evaluating Intravitreal Faricimab Injections or Fluocinolone Acetonide Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss due to Radiation Retinopathy (Protocol AL)
Home OCT-Guided Treatment versus Treat and Extend for the Management of Neovascular AMD (Protocol AO)
Diabetic Retinopathy and Changes in Lipid Metabolism (Protocol AFA)
Genetics in Retinal Disease Project (GEN)

Foundation Fighting Blindness (FFB)

Consortium accelerating the development of treatments for rare inherited retinal disorders.

FFB Public Website

A Natural History Study of EYS Related Retinal Degeneration (Pro-EYS)
A Prospective, Longitudinal Natural History Study of USH2A
Rate of Progression of PCDH15 Related Retinal Degeneration in Usher Syndrome 1F (RUSH1F)
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated with Rare Disease-Causing Genetic Variants (Uni-Rare)
Gyrate Atrophy Ocular and Systemic Study (GYROS)

Pediatric Eye Disease Investigator Group (PEDIG)

Facilitating multicenter clinical research in strabismus, amblyopia and other eye disorders that affect children.

PEDIG Public Website

A Randomized Clinical Trial to Evaluate Sequential vs. Simultaneous Spectacles plus Patching (ATS22)
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age (ATS23)
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age (ATS24)
Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children (IXT7)
Bevacizumab Treatment for Posterior Type 1 Retinopathy of Prematurity (ROP4)

COMPLETED STUDIES

Cornea Donor Study (CDS)

CDS Public Website

Cornea Preservation Time Study (CPTS)

CPTS Public Website

Controlled High Risk Avonex® Multiple Sclerosis Prevention Study in Ongoing Neurological Surveillance (CHAMPIONS)

DRCR Retina Network

Home OCT Monitoring System: Feasibility Study (PROTOCOL AK)
Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk (Protocol W)
Randomized Trial of Intravitreous Aflibercept versus INtravitreous Bevacizumab + Deferred Aflibercept for Treatment of Central-Involved Diabetic Macular Edema (Protocol AC)
Vitreous Proteomics in Eyes with a Macular Hole (Protocol AJ)

Longitudinal Optic Neuritis Study (LONS)

Safety and Feasibility of Cultivated Autologous Limbal Epithelial Cell Transplantation in the Treatment of Limbal Stem Cell Deficiency (CALEC) Study

CALEC Public Website

Surgical Idiopathic Intracranial Hypertension Treatment Trial (SIGHT)

RESEARCH HIGHLIGHTS

The Glucose Levels Across Maternity (GLAM) study primary results were publised in Diabetes Care and BMJ Open Diabetes Research.

The CGM Glycemic Profiles and GDM manuscript examined continuous glucose monitoring-derived patterns and their relation with gestational diabetes mellitus with Dr. Celeste Durnwald from the University of Pennsylvania as lead author.
The Glucose Levels Measured with Continous Glucose Monitoring in Uncomplicated Pregnancies outlined glycemic patterns in otherwise healthy women providing a baseline for further studies with Dr. Anders Carlson from the International Diabetes Center in Minnesota as lead author.

ACTIVE STUDIES

IMAGINE: CGM For the Early Detection and Management of Hyperglycemia in Pregnancy; NCT0657028

COMPLETED STUDIES

Glucose Levels Accross Maternity (GLAM)