Feasibility Study Using Run-to-Run Control to Optimize Continuous Glucose Sensor Bias

NCT02290600 | Completed FDA Device

• 1 other identifier: JDRF KK1413
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this 12 week feasibility study is to see how much more accurate a continuous glucose monitor (CGM) might be in individuals with type 1 diabetes if the investigators personalize sensor calibrations to the user, based on previous wear.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Accuracy of continuous glucose sensor output by individualizing sensor bias in subjects with type 1 diabetes, assessed by quantifying the improvement in CGM accuracy as measured by MARD (mean absolute relative difference).

  3 months

Secondary Outcomes (2)

• Continuous Glucose Monitor sensor bias

  3 months

• Continuous Glucose Monitor sensor failure

  3 months

Study Arms (1)

type 1 diabetes

type 1 diabetes with continuous glucose monitor (CGM)

Device: Continuous Glucose Monitor

Interventions

Continuous Glucose Monitor DEVICE

CGM sensor calibration individualization

Also known as: CGM

type 1 diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 1 diabetes

You may qualify if:

• Clinical diagnosis of type 1 diabetes for at least one year.
• The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Actively using an insulin pump (CSII therapy) for the last 6 months, and will continue to use an insulin pump throughout the trial.
• Age 18 to 75 years.
• For females, not currently known to be pregnant or nursing.
• HbA1c \< 9.5%, as measured with DCA2000 or equivalent device.
• Willing to perform the calibration of the study CGMs using a finger stick only and willing to follow instructions for CGM wear.
• Able to and agrees to avoid the following medication starting 24 hours before sensor wear through completion of the study: acetaminophen, prednisone.
• An understanding of and willingness to follow the protocol and sign the informed consent.

You may not qualify if:

• Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and before phase II) or nursing mother.
• Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization.
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment.
• Current treatment for a seizure disorder: Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist.
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
• Active coronary artery disease or heart failure
• Active gastroparesis
• If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study.
• Uncontrolled thyroid disease: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
• Abuse of alcohol.
• A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
• Current use of a beta blocker medication.
• Laboratory results:
• Hematocrit \< 30% or \>55%.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Related Publications (1)

• Zavitsanou S, Lee JB, Pinsker JE, Church MM, Doyle FJ 3rd, Dassau E. A Personalized Week-to-Week Updating Algorithm to Improve Continuous Glucose Monitoring Performance. J Diabetes Sci Technol. 2017 Nov;11(6):1070-1079. doi: 10.1177/1932296817734367. Epub 2017 Oct 16.

  PMID: 29032732 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jordan Pinsker, M.D.

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: November 14, 2014
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 12, 2018

Record last verified: 2018-07

Locations

US (1)