Studying the Effectiveness of Non-Invasive Glucose Sensors in Patients With Diabetes: The SENSOR Study (SENSOR)

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Wearing a non-invasive glucose sensor

Detailed Description

Self-monitoring of blood glucose (SMBG) can both facilitate and hinder adherence in patients with diabetes mellitus (DM). Readings provide real-time information on hypoglycemic and hyperglycemic excursions. These data are crucial to successfully managing this disease, as SMBG can help guide decisions on titrating medications, and can potentially encourage patient engagement. There are drawbacks. Piercing the skin to check glucose up to several times a day can be uncomfortable and obtrusive for a patient with DM. SMBG offers only a snapshot of the patient's glucose at the time of testing.

Continuous glucose monitoring (CGM) can reveal glucose trends. A subcutaneous sensor transmits interstitial glucose readings approximately every five minutes. Yet, sensor insertion requires a needle. Patients still must test SMBG about 4 times per day to calibrate the CGM sensor. This modality is less accurate with low or rapidly rising glucose. CGM is also not widely available, due to cost and insurance issues. A non-invasive glucose monitor, the GlucoWatch, was discontinued due to problems with accuracy and tolerability.

Compounding these challenges is the surging number of individuals with DM. Every 19 seconds, an American 20 years of age or older is diagnosed with DM. If current trends continue, 1 in 3 Americans could have DM by 2050.

There is thus an unmet need for a non-invasive glucose monitoring device. UCSD nanoengineers developed a flexible, ultra-thin sensor adherent to the skin, similar to a temporary tattoo. Preliminary data from seven individuals without DM demonstrated correlation between glucose measurements from this sensor and a glucometer. Evaluating this sensor in patients with DM will be critical: while hour-to-hour blood glucose fluctuates approximately 50% throughout the day in those without DM, it may vary up to 10-fold in patients with DM. This study would be the first to examine this sensor in individuals with DM. The investigators hypothesize that compared with a glucometer, a tattoo sensor can accurately measure glucose in patients with DM.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • UCSD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. An existing diagnosis of diabetes mellitus, either T1DM or T2DM
2. 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.
3. Ability to provide informed consent for participation.

Exclusion Criteria:

1. Individuals without diabetes
2. Those who have a MOCA score of 26 or less
3. 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.
4. 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.
5. Individuals who have frequent hypoglycemia, hypoglycemia unawareness, or who are at high risk for hypoglycemia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wearing glucose sensor; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy	how the non-invasive glucose sensor measurements correlate with glucometer readings	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acceptability	how acceptable patients find this sensor	1 year

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Actual): March 27, 2018
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: UCSDSOM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No