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CompletedNCT00805506Updated Nov 26, 2015

Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes

An observational study in Diabetes, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-26.

Sponsored by HealthPartners Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16
Ages
18 Years and older
Sex
All
01

Study summary

Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.

Read the detailed description

Many CGM systems use a surrogate for blood glucose--tissue glucose or interstitial glucose. Interstitial fluid (ISF) is the medium for these approaches. A physiological lag in ISF glucose relative to capillary blood glucose has been noted, probably due to relatively low blood perfusion at the sampling site. 9 This physiological lag can result in an accuracy error, manifesting as a significant bias between blood and tissue glucose, particularly during periods of rapid glucose change. This lag error might be particularly meaningful when glucose is rapidly dropping towards hypoglycemia.

02

Conditions studied

  • Diabetes

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Keywords

  • continuous glucose monitoring accuracy
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 16 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.

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

04

Who can participate

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

Study population

adults with diabetes who are treated with insulin

Inclusion criteria

  • adult
  • A1c >7.4 within last 4 months
  • type 1 or 2 diabetes treated with basal/bolus insulin

Exclusion criteria

Exclusion Criteria:

  • under 18 years of age
  • unable to read/write english
  • allergy to adhesives
  • employee of CGM company
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16 participants (actual)

Groups and cohorts

  • Diabetes Insulin Treated

    People with type 1 or type 2 diabetes on insulin.

06

What researchers measure

Primary outcomes

  1. To collect sufficient glucose data by means of continuous glucose monitoring for the purpose of detecting clinically relevant alterations in blood glucose throughout a typical or modal day.

    Time frame: 9 days

07

Study locations

1 site
  • International Diabetes Center
    Minneapolis, Minnesota 55416, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00805506
Lead sponsor
HealthPartners Institute
Collaborators
International Diabetes Center at Park Nicollet, LifeScan
First posted
Dec 9, 2008
Start date
Feb 2006
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Nov 26, 2015

Study contacts

Roger S Mazze, PhD
principal investigator · International Diabetes Center at Park Nicollet
Elinor (Ellie) S Strock, APRN BC
principal investigator · International Diabetes Center at Park Nicollet

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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