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A Clinical Trial of the Accuracy and Treatment Experience of the Dexcom G4 Sensor (Dexcom G4 System)

Discussion in 'Continuous Glucose Sensing' started by Ellen, Oct 3, 2014.

  1. Ellen

    Ellen Senior Member

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    FULL TEXT AT LINK
    http://online.liebertpub.com/doi/full/10.1089/dia.2014.0238

    [h=1]Diabetes Technology & Therapeutics[/h]
    [h=2]A Clinical Trial of the Accuracy and Treatment Experience of the Dexcom G4 Sensor (Dexcom G4 System) and Enlite Sensor (Guardian REAL-Time System) Tested Simultaneously in Ambulatory Patients with Type 1 Diabetes[/h]To cite this article:
    Matuleviciene Viktorija, Joseph Jeffrey I., Andelin Mervi, Hirsch Irl B., Attvall Stig, Pivodic Aldina, Dahlqvist Sofia, Klonoff David, Haraldsson Börje, and Lind Marcus. Diabetes Technology & Therapeutics. -Not available-, ahead of print. doi:10.1089/dia.2014.0238.


    Online Ahead of Print: September 18, 2014

    Navigate ArticleTop of pageAuthor information <<ABSTRACTIntroductionSubjects and MethodsResultsDiscussionAcknowledgmentsAuthor Disclosure Stateme...References[h=3]Author information[/h]

    Viktorija Matuleviciene, MD,[SUP]1[/SUP] Jeffrey I. Joseph, DO,[SUP]2[/SUP] Mervi Andelin, RN, BSc,[SUP]3[/SUP] Irl B. Hirsch, MD,[SUP]4[/SUP] Stig Attvall, MD, PhD,[SUP]1[/SUP] Aldina Pivodic, MSc,[SUP]5[/SUP] Sofia Dahlqvist,[SUP]3[/SUP] David Klonoff, MD,[SUP]6[/SUP] Börje Haraldsson, MD,[SUP]1[/SUP]and Marcus Lind, MD, PhD[SUP]1,[/SUP][SUP]3[/SUP]
    [SUP]1[/SUP]Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.
    [SUP]2[/SUP]Department of Anesthesiology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.
    [SUP]3[/SUP]Department of Medicine, NU-Hospital Organization, Uddevalla, Sweden.
    [SUP]4[/SUP]University of Washington, Seattle, Washington.
    [SUP]5[/SUP]Statistiska Konsultgruppen, Gothenburg, Sweden.
    [SUP]6[/SUP]Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, California.
    This study is registered with ClinicalTrials.gov with clinical trial registration number NCT02159638.
    Address correspondence to:
    Marcus Lind, MD, PhD
    Uddevalla Hospital451 80 Uddevalla,
    Sweden
    E-mail: lind.marcus@telia.com


    Navigate ArticleTop of pageAuthor informationABSTRACT <<IntroductionSubjects and MethodsResultsDiscussionAcknowledgmentsAuthor Disclosure Stateme...References[h=3]ABSTRACT[/h]

    Background: Continuous glucose monitoring (CGM) is a tool widely used in the treatment of patients with type 1 diabetes. The purpose of the current study was to evaluate whether accuracy and patient treatment satisfaction differ between the Enlite™ (Medtronic MiniMed, Inc., Northridge, CA) and Dexcom[SUP]®[/SUP] (San Diego, CA) G4 PLATINUM CGM sensors.
    Subjects and Methods: Thirty-eight ambulatory patients with type 1 diabetes used the Dexcom G4 and Enlite sensors simultaneously for a minimum of 4 and maximum of 6 days. Patients measured capillary glucose levels with a HemoCue[SUP]®[/SUP] (Ängelholm, Sweden) system six to 10 times a day. In addition, two inpatient studies were performed between Days 1–3 and 4–6.
    Results: The mean absolute relative difference (MARD) in blood glucose for the Dexcom G4 was significantly lower (13.9%) than for the Enlite sensor (17.8%) (P<0.0001). The corresponding MARDs for Days 1–3 were 15.0% versus 19.4% (P=0.0027) and 13.6% versus 15.9% (P=0.026) for Days 4–6. For glucose levels in the hypoglycemic range (<4.0 mmol/L), the MARD for the Dexcom G4 was 20.0% compared with 34.7% for the Enlite (P=0.0041). On a visual analog scale (VAS) (0–100), patients rated the Dexcom G4 more favorably than the Enlite in 12 out of the 13 user experience questions. For example, more patients rated their experience with the Dexcom G4 as positive (VAS, 79.7 vs. 46.6; P<0.0001) and preferred to use it in their daily lives (VAS, 79.1 vs. 42.1;P<0.0001).
    Conclusions: The Dexcom G4 sensor was associated with greater overall accuracy than the Enlite sensor during initial (Days 1–3) and later (Days 4–6) use and for glucose levels in the hypoglycemic range. Patients reported a significantly more positive experience using the Dexcom G4 than the Enlite.

     
  2. Mom264

    Mom264 Approved members

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    Hmm. This study used the Enlite with Guardian, which I don't understand. The Enlite works best when used with the 530 G, since its algorithms were made for the Enlite.
    I wish this had compared Enlite with 530G against the Dexcom G4, with many participants. In our experience we have found the G4 much less accurate. (Disappointingly so).:frown:
     
  3. funnygrl

    funnygrl Approved members

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    This study mirrors my experiences with both systems.
     
  4. funnygrl

    funnygrl Approved members

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    Why are you disappointed that the Enlite is more accurate for you? I wish my Enlite preformed better, since I miss having it integrated in my pump and all of the on-device data management the 530g has, compared to exactly no data on the Dexcom, not even daily high/low and average. I also miss being able to scroll back and see the numbers, instead of just where the dot is, and predictive alerts.
     
  5. Ali

    Ali Approved members

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    I think she was saying the research was not a very well done study. I want to see an accurate comparison of the two systems so I can decide which I want to use. If in the study they are not using both devices with the appropriate monitor it is like comparing apples to oranges. I did not read the original papers nor who sponsored the studies so can not even begin to evaluate the studies. In general with research you need large numbers of participants and absolute scrutiny of what you are comparing. So both system have to be compared at their most accurate performance level with the same "relative" individuals being used for comparison. i.e. same age group, sex, activity level, years of T1, years of use with a CGMS system etc.
    Ali
     
  6. funnygrl

    funnygrl Approved members

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    I was replying to the part of the post where she said that the Enlite has been more accurate than the Dexcom for them, disappointingly so. I took that as a personal remark, not one pertaining to the research.
     
  7. funnygrl

    funnygrl Approved members

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    Reading the study, this was done in Sweden. I believe the Enlite is the approved sensor for use with the Guardian there.
     
  8. Mom264

    Mom264 Approved members

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    I'm disappointed because I was hoping it would be so much better accuracy that I wouldn't mind all the give ups that you mention above.

    I have finally decided that MM takes too long to change things, and it is time to go with a different system--or future system. We decided to try the Dexcom since it will be integrating with at least one pump (I am hopeful it will be the bihormonal pump.) and I thought this would be a good time to try it out. (But Why the heck can't I scroll back and see the numbers?!!!)

    Also, the Dexcom range is better than MM, but I cannot put the receiver on my own nightstand and have it read. Of course with MM if DD rolls over and the pump is on one side and sensor/transmitter on the other, we get weak signal and lost sensor. (I appreciate no system is perfect.)

    DD does not like carrying two things. It drove her crazy the one week I had her wear both. (Although I think she likes that the Dexcom looks cool.


    I love the Thresh suspend of MM. (But Thresh suspend doesn't work with lost sensor.)

    I can see everything on MySentry, but it is a PITA to take traveling. There really is nothing perfect yet.

    The second week of the Dexcom, the accuracy improved. Then the next sensor did the same thing. First 5 days inaccurate, the next better. I am not in love with it yet, but I hope it's benefits outweigh the things I do not like.


    Also, I have to decide whether to try the Share or the Nightscout. This means I have to pick a new smartphone (android or iphone) and, as you can probably tell, I have to do a lot of research before I make a change.


    Yes thank you, this is essentially my point about the study.

    OK, wow! Well then this is not my experience.
     
  9. tom_ethansdad

    tom_ethansdad Approved members

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    Dexcom has just released an update for the G4 Platinum that increases its accuracy even more. The press release is here: http://investor.shareholder.com/dexcom/releaseDetail.cfm?ReleaseID=881085.

    I wonder if the study had the new algorithm available as the release states that the update has been used in artificial pancreas research around the world.
     

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