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Current Studies

Type 1 Diabetes Trials:

Study – LPS14947

  • Participant must be 18 to 70 years of age.
  • Participants with T1DM.
  • Participants treated with multiple daily injections (MDI) using basal insulin analog once daily and rapid acting insulin analogs for at least one year.
  • HbA1c ≥7% (48 mmol/mol) and ≤ 10% (86 mmol/mol) at screening.

Study - BDCP

  • Have a diagnosis of T1DM for at least 1 year. A diagnosis of T1DM is based on medical history with a fasting C-peptide ≤0.30 nmol/L at screening.
  • Have been using MDIs without interruption for at least 3 months prior to screening. Are at least 18 years of age, at the time of signing the informed consent.
  • Have HbA1c values of ≤9.5%, as determined by the central laboratory at screening.
  • Have been treated with a stable regimen of insulin glargine, insulin levemir, or insulin degludec for 3 months prior to screening.
  • Are currently treated with the same SC rapid-acting analog insulin (insulin lispro U-100 or U-200, insulin aspart, FiAsp, or insulin glulisine) in MDI for at least the last 30 days prior to screening.
  • Have a body mass index (BMI) ≤35 kg/m2, with no significant weight gain or loss in the past 3 months (≥5%).

Study - CIP326

  • Subject is age 18-80 years at time of Visit 1.
  • Subject has a clinical diagnosis of type 1 diabetes.
  • Diagnosed at least 1 year prior to Visit 1
  • Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
  • If subject has a history of hypothyroidism, must have at least 1 documented normal thyroid-stimulating hormone (TSH) on historical labs within 12 months of Visit 1.
  • Subjects must have Internet access , a computer system that meets the requirements for uploading the study pump and Smartphone that meets study requirements.
  • Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in in the same building (or home). This requirement may be verified by subject report at screening visit.
  • Subjects are willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount) a. Humalog™* (insulin lispro injection) b. NovoLog™* (insulin aspart)

Type 2 Diabetes Trials:

Study – EX4473

  • Male or female, age ≥50 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c 6.5% - 10.0% (47 - 86 mmol/mol) (both inclusive)a
  • At least one of the below conditions (a-d):
    • Coronary heart disease
    • Cerebrovascular disease
    • Symptomatic peripheral artery disease (PAD)
    • Chronic kidney disease defined as:
  • eGFR < 60 mL/min/1.73 m2 b

Study – NN4321

  • Male or female, age ≥ 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus
  • HbA1c ≤ 10% (≤ 86 mmol/mol)
  • Renal impairment defined either by:
    • serum creatinine-based eGFR ≥ 50 and ≤ 75 mL/min/1.73 m2 (CKD-EPI) and UACR > 300 and < 5000 mg/g
      or
    • serum creatinine-based eGFR ≥ 25 and 100 and < 5000 mg/g

Study – NN4352

  • Male or female, age ≥18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 10 years prior to the day of screening.
  • HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).

Study - EFC14875

  • 1 year / 15 office visits / 16 phone visits
  • Type 2 diabetes with HbA1c ≥7% (53 mmol/mol) at Screening
  • Patients either:
    • Age ≥18 years with at least 1 (one) of the major CV risk factor
    • OR
    • In the absence of a major CV risk factor, age ≥55 years with at least 2 (two)of minor CV risk factors

Type 1 or 2 Diabetes Trials:

Study – CIP318

  • Subject is 2-75 years of age at time of screening
  • A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months
  • 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 (Phase 1)/20 minutes (Phase 2) during FST
 
Endocrine Research Solutions, Inc.
1475 Holcomb Bridge Road, Suite 129, Roswell, GA 30076
Ph: 678.878.4750 Fx: 678.878.4751