Is NCT03746769 recruiting in Duarte, CA?

Yes, NCT03746769 is currently recruiting participants at its Duarte, CA location. This diabetes mellitus, type 1 clinical trial is actively enrolling qualified participants.

How do I join the diabetes mellitus, type 1 clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetes Mellitus, Type 1 Clinical Trial in Duarte, CA

About This Diabetes Mellitus, Type 1 Study in Duarte

This clinical study will evaluate the safety and effectiveness of Gastrin treatment with islet transplantation to help patients with difficult to control type 1 diabetes make insulin again and improve blood sugar control. This study involves two investigational (experimental) products not yet approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease: 1. Human allogenic islet cells (islet cells from a deceased, unrelated human donor) 2. Gastrin-17 (Gastrin) - a hormone secreted by the gut

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Age 18-68 years

Type 1 diabetes mellitus (documented with fasting C-peptide level of \</= 0.2 ng/ml before and \</= 0.3 ng/ml after IV administration of 1 mg of glucagon) for at least 5 years.

Unstable blood glucose characterized by: Frequent hypoglycemia (blood glucose less than or equal to 54 mg/dl more than once per week) -and/or- Hypoglycemia unawareness (Clarke score of 4 or more). -and/or- One or more severe hypoglycemic episodes in 12 months preceding enrollment -and/or- Erratic blood glucose levels that interfere with daily activities -and/or- One or more hospital visits for diabetic ketoacidosis in the 12 months preceding enrollment

Ability and willingness to comply with post-transplant regimen, including immunosuppression, use of reliable contraception, frequent clinic visits, testing and maintaining detailed logs of blood glucose levels, insulin doses and medications, and completing detailed follow-up studies.

Ability to give informed consent.

Fully vaccinated against COVID-19

Exclusion Criteria

Insulin requirements \> 1.0 units/kg/day

Significant kidney disease (estimated GFR from serum creatinine measurement \<65 ml/min, random spot urine microalbumin to creatinine ratio \>300mg albumin/g creatinine)

Significant hepatobiliary disease, including elevation of liver enzymes \> twice the upper limit of normal for each of ALT and AST (any elevation of these enzymes will be determined), bilirubin not within normal limits, albumin \< 3.5 g/dl, liver masses, portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e. gallstones)

Significant cardiovascular disease, including non-correctable coronary artery disease with ejection fraction \< 50% and/or recent myocardial infarction (within last 12 months); or extensive peripheral vascular disease not correctable by surgery,

Evidence of active proliferative retinopathy

Hypertension( \>/= 140/90) despite appropriate treatment

Hyperlipidemia (total cholesterol \> 260 mg/dl, LDL \> 160 mg/dl, and/or triglycerides \> 300 mg/dl) despite appropriate treatment

Anemia (Hgb \< 11 g/dl) or other hematologic disorders that require medical attention

WBC \<3,000/ul

Increased risk of bleeding (platelet count \< 120,000 cells/ul; INR \> 1.5), other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy (i.e. heparin or warfarin)

Recent unresolved acute infection (except for mild skin infection or nail fungal infection), or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or syphilis (RPR)

EBV IgG negative

Any history of malignancy, except completely resected squamous or basal cell skin cancer or in situ cancer of the cervix

Evidence of active peptic ulcer disease

History of gastric bypass

Recent history of non-adherence to recommended medical therapy

Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment

Previous organ/tissue transplant

Administration of live attenuated vaccines within 60 days of enrollment.

Presence of a chronic disease that must be chronically treated with contraindicated medications

Use of investigational agents within four weeks of enrollment

Active alcohol or substance abuse, including cigarette smoking (must be abstinent for \> 3 months)

Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures (i.e., tubal ligation, two barrier methods, abstinence) for the duration of study treatment and for as long as they are on immunosuppressive medication, and women presently breastfeeding.

Individuals without health insurance covering the cost of immunosuppression and clinical and laboratory follow-up after completion of the study

Any medical condition that in the opinion of the investigator will interfere with safe participation in the trial

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Duarte?

Yes, this clinical trial (NCT03746769) has an active research site in Duarte, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diabetes Mellitus, Type 1 Treatment Options in Duarte, CA

If you're searching for diabetes mellitus, type 1 treatment options in Duarte, CA, this clinical trial (NCT03746769) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Duarte research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced diabetes mellitus, type 1 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetes mellitus, type 1 clinical trials near you to find additional studies recruiting in your area.

Diabetes Mellitus, Type 1 Clinical Trial in Duarte, CA

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