Last updated on February 2016

Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes: DIaMonD Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Mellitus Types I and II
  • Age: 25 Years
  • Gender: Male or Female

To take part in this study, you must:

  • Be 25 years of age or older and be able to speak, read, and write English
  • Have been diagnosed with Type 1 diabetes mellitus
  • Be on Multiple Daily Injections (MDI) using 3 insulin injections minimum per day for at least 12 months prior to study entry
  • Be followed regularly for your diabetes by a physician or diabetes educator with at least 2 visits in the last year
  • Have stable weight maintained 3 months prior to study entry (according to your study doctor)
  • Have the desire to lower your A1C
  • Be willing, if asked, to wear an FDA-cleared insulin pump and use CGM
  • Avoid the use of acetaminophen medications throughout the study
  • Have been taking an average of 3 finger sticks per day (by history)

You Must Not:

  • Have used real-time continuous glucose monitoring (RT-CGM) in the 6 months prior to study entry
  • Have used an insulin pump within 3 months prior to study entry
  • Be planning to use personal CGM and/or an insulin pump during the course of the study
  • Have recently added a new oral or injectable blood sugar agent in the past 3 months
  • Be currently taking or planning to take oral, injectable or IV steroid hormones (glucocorticoids) 12 weeks prior to study entry or plan to take any during the course of the study (Long term/stable use allowed, such as for treating rheumatoid arthritis or Addison's disease)
  • Have had a recent hospitalization or ER visit in the past 6 months prior to screening as a result of uncontrolled diabetes
  • Be currently participating in another investigational study (you must have completed any previous studies at least 30 days prior to being enrolled in this study)
  • Plan any weight reduction during the study which involves prescribed weight reduction medicines or surgery
  • Have used pre-mixed insulin (e.g. 70/30 or 50/50)
  • Have a history of visual impairment that may hinder your participation in the study to perform all study procedures safely, as determined by investigator
  • Have a history of psychiatric, psychological disorder, or psychosocial issues that could limit your adherence to required study tasks
  • Be currently abusing illicit drugs, alcohol or prescription drugs
  • Have kidney disease
  • Have extensive skin changes/disease that would prevent you from wearing the sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed sensor sites
  • Have any known allergy to medical-grade adhesives

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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