NCT02800044

Brief Summary

The overall goal for this pilot clinical trial is to explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings with glucometer measurements from patients with type 1 or type 2 diabetes (T1DM or T2DM), under varying conditions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

June 6, 2016

Last Update Submit

July 27, 2020

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • accuracy

    how the non-invasive glucose sensor measurements correlate with glucometer readings

    1 year

Secondary Outcomes (1)

  • acceptability

    1 year

Study Arms (1)

Wearing glucose sensor

EXPERIMENTAL

The study team will measure glucose readings from the non-invasive sensor and from a glucometer at the following time points: fasting, 1.5 to 2 hours after a meal, and before and after 15-30 minutes of pedaling on a stationary bicycle at 80% maximum heart rate..

Device: Wearing a non-invasive glucose sensor

Interventions

Wearing a non-invasive glucose sensorDEVICE

Glucose readings will be obtained from both a glucometer (fingerstick readings) and from the non-invasive glucose sensor at the following four timepoints: fasting, 1.5 to 2 hours after consuming a meal, and before and after 15-30 minutes of moderate exercise on a stationary bicycle.

Wearing glucose sensor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An existing diagnosis of diabetes mellitus, either T1DM or T2DM
  • Absence of cognitive impairment, as demonstrated by a Montreal Cognitive Assessment (MOCA) score greater than 26; those individuals with questionable cognitive ability will be screened with this instrument.
  • Ability to provide informed consent for participation.

You may not qualify if:

  • Individuals without diabetes
  • Those who have a MOCA score of 26 or less
  • Those who cannot speak or read English. The investigators are limiting participation to those who read and speak English, as this is a pilot study of a small number of participants, that will very unlikely offer the prospect of direct benefit from participating.
  • Individuals who have a cardiac, respiratory, or other condition that would preclude safely exercising at a moderate pace. Along with a medical history and physical examination by the PI, prospective participants will complete the Physical Activity Readiness Questionnaire (PAR-Q) to help determine those who may safely exercise for this study. One or more "yes" responses does not necessarily exclude an individual from participating.
  • Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at high risk for hypoglycemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD

San Diego, California, 92161, United States

Location

Related Publications (1)

  • Bandodkar AJ, Jia W, Yardimci C, Wang X, Ramirez J, Wang J. Tattoo-based noninvasive glucose monitoring: a proof-of-concept study. Anal Chem. 2015 Jan 6;87(1):394-8. doi: 10.1021/ac504300n. Epub 2014 Dec 12.

    PMID: 25496376BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Edward C Chao, DO

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor of Medicine

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 15, 2016

Study Start

March 14, 2017

Primary Completion

March 27, 2018

Study Completion

March 27, 2018

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)