CClinicalTrials.gg
Sign In
CompletedNCT02241993Updated Sep 16, 2014

The Multi-Sensor Distance Accuracy Study

An observational study in Type 1 Diabetes Mellitus, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-09-16.

Sponsored by Oregon Health and Science University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of the study is to test the accuracy benefit of having two glucose sensors (over one sensor alone) when they are positioned: 2mm, 10mm, 20mm, or 30mm apart. It is not yet known how close two sensors can be and still work correctly.

Read the detailed description

An artificial pancreas system will likely require multiple glucose sensing elements to function safely. It is not yet known how close two glucose sensors can be placed and still work properly. Meaning, if one is reading inaccurately,and the other is positioned adjacent to it, will it read inaccurately also, defeating the purpose of having two sensors. Twenty adult subjects with Type 1 diabetes will wear four Medtronic REAL-Time glucose sensors during two separate 10-hour studies. The inter-sensor distances of each pair to be tested will be: 2, 10, 20, and 30mm apart. The sensors will be inserted the day prior to the study day to allow for signal stabilization and calibration. During the study day, arterialized venous blood will be drawn every 15 minutes to measure blood glucose. The sensor values and interstitial values will be recorded from each sensor receiver at each time point. Subjects will be fed two standardized meals and given pre-meal insulin based on their typical insulin to carbohydrate ratio.

02

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • glucose sensor
  • Inter-sensor distance
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 20 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

clinical practice Type 1 patients

Eligibility criteria

Inclusion Criteria:

  1. Type 1 diabetes mellitus diagnosed for at least 6 months
  2. Current usage of multiple daily injections or subcutaneous insulin pump treatment
  3. Age 18-65 years
  4. HbA1c of 6.0 - 9.5% at screening visit
  5. BMI 21-35
  6. Willingness to follow all study procedures, including attending all clinic visits
  7. Willingness to sign informed consent and HIPAA documents

Exclusion Criteria: Subjects presenting with any of the following will not be included in the study.

  1. Pregnancy or Lactation: for women of childbearing potential there is a requirement for a negative urine pregnancy test.
  2. Renal insufficiency (serum creatinine of 2.0 mg/dL or greater). Serum ALT or AST equal to or greater than 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as a serum albumin of less the 3.3 g/dL; or serum bilirubin of over 2.
  3. Hematocrit of less than or equal to 34%.
  4. Congestive heart failure, NYHA class III or IV.
  5. Visual impairment preventing reading of glucose meter values.
  6. Active coronary artery disease as manifested by unstable angina, or a myocardial infarction or therapeutic coronary percutaneous procedure (e.g., PTCA, stent placement) or CABG within the past 4 months.
  7. Active foot ulceration.
  8. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
  9. Cerebrovascular accident within the past 6 months.
  10. Active alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator).
  11. Active malignancy, except basal cell or squamous cell skin cancers.
  12. Major surgical operation within 30 days prior to screening.
  13. Seizure disorder (epilepsy).
  14. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
  15. Currently administration of oral or parenteral corticosteroids.
  16. Use of an investigational drug within 30 days prior to screening.
  17. Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (actual)

Groups and cohorts

  • Type 1 diabetic
06

What researchers measure

Primary outcomes

  1. Difference between very large sensor accuracy errors (≥50% from reference glucose) with the simultaneous use of four sensors vs one sensor.

    Time frame: 9-hour collection period, X 2

Secondary outcomes

  1. Difference between mean absolute relative difference with the simultaneous use of four sensors vs one sensor.

    Time frame: 9-hour glucose level collection, X 2

07

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
08

References and documents

Publications

  • Ward WK, Casey HM, Quinn MJ, Federiuk IF, Wood MD. A fully implantable subcutaneous glucose sensor array: enhanced accuracy from multiple sensing units and a median-based algorithm. Diabetes Technol Ther. 2003;5(6):943-52. doi: 10.1089/152091503322640980. PubMed 14709196 ↗
  • Schmidtke DW, Pishko MV, Quinn CP, Heller A. Statistics for critical clinical decision making based on readings of pairs of implanted sensors. Anal Chem. 1996 Sep 1;68(17):2845-9. doi: 10.1021/ac9602027. PubMed 8794921 ↗
  • Castle JR, Engle JM, El Youssef J, Massoud RG, Yuen KC, Kagan R, Ward WK. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care. 2010 Jun;33(6):1282-7. doi: 10.2337/dc09-2254. Epub 2010 Mar 23. PubMed 20332355 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02241993
Lead sponsor
Oregon Health and Science University
Collaborators
The Leona M. and Harry B. Helmsley Charitable Trust
Responsible party
W Kenneth Ward MD (Associate Professor, Oregon Health and Science University) — Principal investigator
First posted
Sep 16, 2014
Start date
Jul 2010
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Sep 16, 2014

Study contacts

W. Kenneth Ward, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 1→

Other studies from this sponsor

Oregon Health and Science University

Start the discussion