Effects of Capros in Patients With Type-1 Diabetes
Condition: Type I Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this 12 week longitudinal study is to test the effect of the dietary
      supplement, Capros, on blood glycemic index of Type 1 diabetics that have a sensor that
      provides continuous glucose monitoring (CGM). 20 Type 1 Diabetics will take the Capros
      supplement for 12 weeks to determine the effect of blood glycemic index. Capros, is a
      generally safe dietary supplement currently sold over the counter in the United States. Type
      1 diabetes also known as juvenile diabetes is commonly diagnosed in children and young
      adults. Insulin is converted into energy needed for daily living, and with diabetes, insulin
      is not produced in the body as it should causing many problems. In traditional Indian
      medicine, the gooseberry Phyllanthus emblica has been used for thousands of years as an
      effective source of polyphenols and antioxidants. A 12 week longitudinal study to determine
      the effect of the dietary supplement, Capros, on the blood glycemic index in patients with
      Type 1 diabetes (T1D).
    

Detailed description: 
      There are a total of 4 study visits,over the course of 12 weeks. These visits will occur on
      weeks 1, 4, 8, and 12. At each study visit the the following will be recorded: Age, Sex,
      Pulse, height, weight, CGM real time measurement and the following non-medical information
      will be recorded: Address, Phone number and Email address ( will be recorded at the first
      visit and will be asked if anything has changed at the reoccurring visits). The following
      will happen at each visit:

      Visit 1 (Week 0): The subject will be presented with informed consent. Data will be collected
      on a data collection sheet, a finger stick for A1C will be obtained (if not completed as
      SoC), Continuous Glucose Monitoring will be downloaded, UPT for WCBP will be performed, the
      subject will be given a 4-week supply of the Capros supplement and a subject diary. The
      subject will be given a subject diary to document their morning/evening sugar and the time of
      when participants take the supplements. The subject will be asked to bring in the diary to
      each follow-up visit to check for compliance verification.

      Visit 2 and 3 (Week 4 and 8): The following activities will take place during these visits:
      AE review, concomitant medications review, weight, vital signs, CGM download, pill count and
      distribution, collect previous diary and provide new.

      Visit 4 (Week 12): The following activities will take place during these visits: AE review,
      concomitant medications review, weight, vital signs, CGM download, pill count, collect
      previous diary. Also, at this visit, a finger stick for A1C (if not completed as SoC), no
      further distribution of supplements.

      Taking the supplement: After receiving the supplement, the subject is instructed to take 2
      capsules per day by mouth, once with food around lunchtime and once with food around dinner
      time for a total of 12 weeks. The subjects will be asked to keep all empty bottles/ any
      remaining Capros supplements and bring them to each follow-up visit for a compliance check.
      Participants will receive a new 4-week supply of supplements at study visits 2 and 3.

      Risks for participating in this study are extremely low. Capros is a dietary supplement
      derived from the Indian Gooseberry, and contains no artificial ingredients, is non-toxic and
      is safely tolerated among humans. Capros is currently sold over the counter in the U.S. and
      has no known side effects; however an allergic reaction to the supplement is possible.

      There is a potential risk for hypoglycemia while taking this supplement. In the even that
      this occurs, subjects are instructed to follow their primary care physician instructions for
      this and record it on their data log.

      This is not a treatment study so subjects may have no direct benefit while taking the
      supplement. The investigators are looking to monitor and observe if any changes take place
      with participants blood sugar level over the course of the study.
    

Intervention name(s): Capros
Intervention type(s): Dietary Supplement
Intervention description(s): 250 mg BID
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hyperglycemia; Capros; Type 1 Diabetes