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Current Studies

Cardiac Trials

Study – EX4758

  • eGFR ≥15 and < 60 mL/min/1.73 m2
  • Serum hs-CRP ≥2 mg/L at screening
  • Evidence of ASCVD by one or more of the following within the last 5 years from screening:
    • Coronary heart disease defined as at least one of the following:
    • Cerebrovascular disease defined as at least one of the following:
    • Symptomatic peripheral artery disease (PAD) defined as at least one of the following:

Study – TA-8995-304

  • Are men or women ≥18 years of age at Screening.
  • Have a history of ASCVD.
  • Are on maximally tolerated lipid-modifying therapy.

Type 2 Diabetes Trials:

Study – CIP341

  • Is age 18 - 80 years at time of screening.
  • Has a clinical diagnosis of type 2 diabetes for 2 years or more.
  • Is on multiple daily injection (MDI) regimen (basal/bolus regimen with longacting insulin and rapid-acting analogs), defined as greater than or equal to 2 injections per day for at least 3 months.
  • Is willing to perform fingerstick blood glucose measurements as needed.
  • Is willing to wear the system continuously throughout the study.
  • Has a Glycosylated hemoglobin (HbA1c) of less than 10% (as processed by Central Lab) at time of screening visit.
  • Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.

Study – NN4591

  • Male or female and age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
  • HbA1c of 7.0-10.0%.
  • Treated with once daily or twice-daily basal insulin.
  • Body mass index (BMI) ≤ 40.0 kg/m2.

Study - NN4592

  • Male or female and age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
  • HbA1c of 7.0-10.0%
  • Insulin naïve. The following exceptions are permitted: short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes.
  • Treated with stable doses of daily or weekly GLP-1 receptor agonist (excluding once weekly semaglutide with doses higher than 1.0 mg) according to local label for the treatment of diabetes ≥ 90 days before screening.
  • Body mass index (BMI) ≤ 40.0 kg/m2 .

Type 1 or 2 Diabetes Trials:

Study – CIP322

  • Individual is 2-75 years of age at time of enrollment.
  • Subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
  • Subject is using insulin to treat their diabetes.
  • Subject agrees to comply with the study protocol requirements.
  • Subject is willing to perform SMBG approximately every 15 minutes /20 minutes during FST.
  • If subject is participating in YSI FST, subject has adequate venous access as assessed by investigator or appropriate staff.

Study – CIP331

  • Individual is 2-80 years of age at time of consent
  • A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator for:
    • at least the last 6 months for subjects 2-6 years of age
    • at least the last 12 months for subjects 7-80 years of age
  • Subject is on multiple daily injection therapy
  • Subject is currently using or is willing to use the Guardian Connect system during the study
  • Subject agrees to comply with the study protocol requirements

Study – CIP335

  • Age 18-80 years at time of screening.
  • Has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
  • Is willing to perform fingerstick blood glucose measurements as needed.
  • Is willing to wear the system continuously throughout the study.
  • Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
  • Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of
  • Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range, the Free T3 is below or within the lab’s reference range and Free T4 is within the normal reference range.
  • Uses pump therapy prior to screening: greater than 6 months prior to screening (with or without CGM experience)
  • Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.
  • Is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations as required during the run-in period:
    • Humalog (insulin lispro injection)
    • NovoLog (insulin aspart injection)
  • Is willing to take Lyumjev insulin during the study period (supplied via Sponsor).

Study – CIP336 – Pump Trial

  • Age 2 - 80 years at time of screening.
  • Has a clinical diagnosis of type 1 diabetes:
  • Is willing to perform fingerstick blood glucose measurements as needed.
  • Is willing to wear the system continuously throughout the study.
  • Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
  • Has a Glycosylated hemoglobin (HbA1c) less than 10% 
  • Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab’s reference range and Free T4 is within the normal reference range.
  • Uses pump therapy prior to screening
  • Is willing to take Fiasp insulin during the study period (supplied via Sponsor).
 
Endocrine Research Solutions, Inc.
1475 Holcomb Bridge Road, Suite 129, Roswell, GA 30076
Ph: 678.878.4750 Fx: 678.878.4751