NCT03460964

Brief Summary

This pilot clinical trial will 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 from sweat with glucometer measurements from patients with any type of diabetes at fasting, and after a meal.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2018

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2019

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

February 23, 2018

Last Update Submit

July 7, 2020

Conditions

Diabetes Mellitus

Keywords

SensorGlucoseSweat

Outcome Measures

Primary Outcomes (1)

  • Glucose measurements

    Comparing glucose readings from the sensor with those from a glucometer

    Fasting, and time points ranging from 15 to 200 minutes after consuming a standardized meal. Participants can complete this study in 1 or 2 visits. The study team anticipates to complete this clinical trial in approximately 1 year.

Secondary Outcomes (1)

  • Acceptability of sensor

    The investigators will collect this data at the completion of the study, after the fasting and post-meal glucose readings (at time points ranging from 15 to 200 minutes) are collected.

Study Arms (1)

Patients with Diabetes

EXPERIMENTAL

All participants will receive a minimum of 2 doses of pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat. Glucose will be measured with both an adhesive (needle-free) glucose sensor and a glucometer, at fasting, and time points ranging from 15 to 200 minutes after consuming a standardized meal. There are no other interventions.

Device: Adhesive glucose sensorDrug: Pilocarpine

Interventions

Adhesive glucose sensorDEVICE

Will assess sensor's performance by comparing readings from an adhesive glucose sensor with those from a glucometer. pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat

Patients with Diabetes
PilocarpineDRUG

Pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat; will apply a minimum of 2 doses to each participant.

Patients with Diabetes

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with an existing diagnosis of diabetes mellitus, of any type, defined as having a fasting plasma glucose (FPG) \> 126 mg/dL, or hemoglobin A1c (HbA1c) \> 6.5%.
  • Ability to provide informed consent for participation.

You may not qualify if:

  • Individuals who do not have diabetes.
  • Those who have an allergy to pilocarpine.
  • Frequent episodes of low blood sugar (hypoglycemia), have no warning symptoms of hypoglycemia (hypoglycemia unawareness), or are at high risk of having hypoglycemia.
  • If taking any of the following medications: any beta-blockers (including atenolol, carvedilol, metoprolol, and propanolol), chlorthalidone, hydrochlorothiazide, oxybutynin, and tiotropium.
  • Individuals who have the following conditions, for which it is not safe to take pilocarpine, including:
  • Known or suspected gallstones or gallbladder disease
  • Kidney stones
  • Conditions that affect your thinking and/or memory, including Parkinson's disease and Alzheimer's disease
  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Glaucoma
  • Irritable Bowel Syndrome
  • Pregnancy - a pregnancy test will be obtained for each woman of child-bearing age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSD Altman Clinical and Translational Research Institute

San Diego, California, 92161, United States

Location

UCSD

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Pilocarpine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Edward C Chao, DO

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 9, 2018

Study Start

May 1, 2018

Primary Completion

September 5, 2019

Study Completion

September 5, 2019

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

US(2)