Three-day, In-clinic Evaluation of the BD 2nd Generation Continuous Glucose Sensor Device in Type 1 Diabetics

NCT01645696 | Completed

• 1 other identifier: BDT-11-CGM002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the accuracy and performance of a new subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high blood sugar) and hypoglycemic (low blood sugar) "clamp" conditions and during meal excursions over the course of 72 hours as compared to a commercially available monitor.

Conditions

Diabetes

Keywords

Diabetes; Type 1 Diabetes; Continuous glucose monitoring; Blood glucose; Blood glucose sensor; Glucose Binding Protein (GBP)

Outcome Measures

Primary Outcomes (2)

• Blood Glucose

  Blood glucose will be measured by the BD-Continuous Glucose Monitor, with and without outer layer, the commercially available Medtronic iPro2 and the YSI (Yellow Springs Instrument) Glucose analyzer (control) for 72 hours. Blood glucose will be used to determine performance of the device to include warm up behavior, lag time and accuracy of the blood glucose monitor over 72 hours.

  72 hours

• Number of participants with adverse events

  At each study contact, subjects will be questioned about any adverse events that may have occurred and are potentially related to the device.

  up to 89 days or until the subject is discharged

Secondary Outcomes (4)

• Skin Effects-Draize Scoring for Skin Irritation

  Up to 36 days

• Skin thickness using ultrasound

  Upon removal of the devices

• Insulin levels

  72 hours

• antibodies against the glucose binding protein

  36 days

Study Arms (3)

BD Continuous Glucose Monitor (CGM) with outer layer

EXPERIMENTAL

A subcutaneous glucose binding protein sensing device to continuously monitor glucose in diabetics.

Device: BD CGM with Outer Layer

BD CGM without outer layer

EXPERIMENTAL

A continuous glucose binding protein sensing device used to monitor glucose in Diabetics

Device: BD CGM without Outer Layer

Medtronic iPro 2 Professional CGM

ACTIVE COMPARATOR

Commercial glucose oxidase continuous glucose monitor

Device: Medtronic iPro2 Professional CGM

Interventions

BD CGM with Outer Layer DEVICE

continuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours.

BD Continuous Glucose Monitor (CGM) with outer layer

BD CGM without Outer Layer DEVICE

continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.

BD CGM without outer layer

Medtronic iPro2 Professional CGM DEVICE

continuous subcutaneous glucose monitoring for 72 hours

Medtronic iPro 2 Professional CGM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of type 1 diabetes mellitus for ≥1 year. For an individual to be enrolled at least one criterion from each list must be met.
• Criteria for documented hyperglycemia (at least 1 must be met):
• Fasting glucose ≥ 7 mmol/L \[126 mg/dL\] - confirmed
• Two-hour OGTT (oral glucose tolerance test) glucose ≥ 11.1 mmol/L \[200 mg/dL\] - confirmed
• HbA1c ≥6.5% documented - confirmed
• Random glucose ≥ 11.1 mmol/L \[200 mg/dL\] with symptoms
• No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
• Criteria for requiring insulin at diagnosis (1 must be met):
• Participant required insulin at diagnosis and continually thereafter
• Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually
• Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually
• Signed informed consent
• Age ≥18 and ≤65 years old
• Body mass index between 19 and 35 kg/m2, inclusive
• HbA1c ≤ 10.0%

You may not qualify if:

• Uncontrolled arterial hypertension (diastolic blood pressure \> 90 mm Hg and/or systolic blood pressure \> 160 mm Hg)
• Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥ three times the upper reference limit
• Impaired renal function measured as creatinine \> 1.2 times above the upper limit of normal
• Diabetic ketoacidosis in the past 6 months
• Severe hypoglycemia resulting in a seizure or loss of consciousness in the 6 months prior to enrollment
• Current use of medications containing \> 4000 mg acetaminophen per day.
• Current use of MAO (monoamine oxidase) inhibitors.
• Known allergy to eggs
• Pregnancy, breast-feeding or intention of becoming pregnant
• Current or recent alcohol or drug abuse by subject history.
• Blood donation of more than 473 ml within the last 56 days
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
• Any skin condition that prevents sensor placement on the abdomen (e.g., bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
• Known allergy to medical adhesives, e.g. Tegaderm
• Hematocrit \< 38% (males) and \< 36% (females)

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

>LMC Endocrinology Centre, Clinical Research Unit

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Ronnie Aronson, MD

  LMC Endocrinology Centre, Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 20, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

CA (1)