Is NCT07228117 recruiting in Stanford, CA?

Yes, NCT07228117 is currently recruiting participants at its Stanford, CA location. This type 1 diabetes mellitus clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Stanford, 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 Stanford 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.

Type 1 Diabetes Mellitus Clinical Trial in Stanford, CA

About This Type 1 Diabetes Mellitus Study in Stanford

The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5/Simplera Sync in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Participants will use their current therapy while also wearing the DS5/Simplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if participants like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.

Sponsor: Medtronic MiniMed, Inc.

Who Can Participate

Inclusion Criteria

Age at time of screening according to diabetes type:

T1D: Age 7-85 years

T2D: Age 18-85 years

Has a clinical diagnosis of diabetes for a minimum per diabetes type below:

T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.

T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis

Is willing to provide informed consent/assent for participation.

Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.

Is willing to wear the system continuously throughout the study.

Has results of a retinal eye examination on record prior to enrollment, per guidelines by the American Diabetes Association according to age, duration of diabetes and type of diabetes:

T1D adults (Age 18-85 years): I. Initial retinal eye exam within 5 years of diagnosis. II. If the duration of type 1 diabetes is longer than 5 years, a retinal examination should have been performed within the last 12-18 months.

T2D adults (Age 18-85 years): I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.

T1D pediatric (Age 7-17 years): I. No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years. II. For children over the age of 10, a retinal exam should have been performed within 24 months of enrollment in the study. Per the investigator's discretion: If a potential participant is deemed to be at high risk, a retinal eye exam, performed within the last 12 months prior to screening, should be on record.

Is willing to upload study pump data via an app or computer.

Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:

(insulin lispro injection)

(insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™\*)

NovoRapid™\

(insulin aspart solution for injection)

(insulin lispro injection)

(insulin aspart)

(ultra-rapid-acting insulin aspart)

(ultra-rapid-acting insulin lispro)

Authorized generic insulin aspart

Authorized generic insulin lispro

Exclusion Criteria

Unable to consent due to a mental or intellectual disability.

Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:

Medical assistance (i.e., Paramedics, Emergency Room \[ER\] or Hospitalization)

Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.

T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.

Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

Currently pregnant or planning to become pregnant during the time period of study participation

A negative pregnancy test will be required for all females of child-bearing potential at time of screening

For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable

At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.

Has diagnosis of adrenal insufficiency.

Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.

T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and/or Glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) containing medications (e.g., Mounjaro), in the 8 weeks prior to screening.

Participants who have stopped using metformin and/or GLP-1/GIP have done so at least 8 weeks prior to screening.

Participants currently taking metformin and/or GLP-1/GIP must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study.

T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1 /GIP containing medications (e.g., Mounjaro), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.

Participants who have stopped using metformin, GLP-1/GIP or SGLT2 have done so at least 8 weeks prior to screening.

Participants currently taking metformin, GLP-1/GIP or SGLT2 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study

Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.

Is using inhalable insulin in the 8 weeks prior to screening.

Is using hydroxyurea at time of screening or plans to use it during the study

Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study.

Is, at the discretion of the investigator, abusing drugs or alcohol.

Is, in the opinion of the investigator, not able to perform all study procedures safely.

Has a history of visual impairment which would not allow subject, even with the help of a caregiver, to participate in the study and perform all study procedures safely, as determined by the investigator.

Has elective surgery planned that requires general anesthesia during the course of the study.

Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.

Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.

Is diagnosed with current eating disorder such as anorexia or bulimia.

Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c

Is on dialysis.

Has an estimated Glomerular Filtration Rate (eGFR) \<30.

Has celiac disease that is not adequately treated as determined by the investigator.

Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.

Has had any of the following cardiovascular events more than 1 year prior to screening and should not participate at the discretion of the investigator: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.

Is a member of the research staff involved with the study.

Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).

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 Stanford?

Yes, this clinical trial (NCT07228117) has an active research site in Stanford, 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.

Type 1 Diabetes Mellitus Treatment Options in Stanford, CA

If you're searching for type 1 diabetes mellitus treatment options in Stanford, CA, this clinical trial (NCT07228117) 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 Stanford research site is actively enrolling participants for this clinical trial. You'll receive care from experienced type 1 diabetes mellitus 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 type 1 diabetes mellitus clinical trials near you to find additional studies recruiting in your area.

Type 1 Diabetes Mellitus Clinical Trial in Stanford, CA

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