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

NCT ID: NCT01645696

Last Updated: 2021-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-09-30

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.

Detailed Description

This is a single site, non-randomized study. The study consists of a Screening Visit (Visit 1) during which the subject will be consented and the inclusion exclusion criteria confirmed. An interventional visit (Visit 2)which consists of a 72 hour in-clinic stay and a Follow-up Visit (Visit 3). Subjects eligible for the study will be admitted to the clinic for the Study Visit 2 in the afternoon on the day before the first Clamp is performed. An IV line for blood sampling will be established. One blood sample will be obtained for glucose determination and a second blood sample will be collected for immunoassay development before any sensors are inserted. Two BD-Glucose Binding Protein-Continuous Glucose Monitor Sensors(BD-GBP-CGM), with and without outer layer, and one commercial CGM sensor will be inserted in the subcutaneous tissue in the abdomen shortly thereafter. Blood sampling intervals will be adjusted over the 3 study days as determined by the study event (i.e. clamp period, meal excursion, nighttime). During the hyper- /hypo-glycemic clamps periods on Day 1 and Day 3 blood samples will be taken more frequently, every 5-10 minutes. During the breakfast meal on Day 2 sampling will occur at 10-15 minute intervals for 4 hours to capture the meal excursion. Sampling will be less frequent during the evening meal and at night during sleep hours.

Conditions

Diabetes

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

BD Continuous Glucose Monitor (CGM) with outer layer

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

Group Type: EXPERIMENTAL

BD CGM with Outer Layer

Intervention Type: DEVICE

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

BD CGM without outer layer

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

Group Type: EXPERIMENTAL

BD CGM without Outer Layer

Intervention Type: DEVICE

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

Medtronic iPro 2 Professional CGM

Commercial glucose oxidase continuous glucose monitor

Group Type: ACTIVE_COMPARATOR

Medtronic iPro2 Professional CGM

Intervention Type: DEVICE

continuous subcutaneous glucose monitoring for 72 hours

Interventions

BD CGM with Outer Layer

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

Intervention Type: DEVICE

BD CGM without Outer Layer

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

Intervention Type: DEVICE

Medtronic iPro2 Professional CGM

continuous subcutaneous glucose monitoring for 72 hours

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Criteria for documented hyperglycemia (at least 1 must be met):

1. Fasting glucose ≥ 7 mmol/L [126 mg/dL] - confirmed

2. Two-hour OGTT (oral glucose tolerance test) glucose ≥ 11.1 mmol/L [200 mg/dL] - confirmed

3. HbA1c ≥6.5% documented - confirmed

4. Random glucose ≥ 11.1 mmol/L [200 mg/dL] with symptoms

5. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes

3. Criteria for requiring insulin at diagnosis (1 must be met):

1. Participant required insulin at diagnosis and continually thereafter

2. 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

3. 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

4. Signed informed consent

5. Age ≥18 and ≤65 years old

6. Body mass index between 19 and 35 kg/m2, inclusive

7. HbA1c ≤ 10.0%

Exclusion Criteria

1. Uncontrolled arterial hypertension (diastolic blood pressure > 90 mm Hg and/or systolic blood pressure > 160 mm Hg)

2. Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥ three times the upper reference limit

3. Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal

4. Diabetic ketoacidosis in the past 6 months

5. Severe hypoglycemia resulting in a seizure or loss of consciousness in the 6 months prior to enrollment

6. Conditions which may increase the risk of hypoglycemia or conditions of known microvascular (diabetic) complications will be assessed on an individual basis with exclusion based on the discretion of the principal investigator.

7. Current use of medications containing > 4000 mg acetaminophen per day.

8. Current use of MAO (monoamine oxidase) inhibitors.

9. Known allergy to eggs

10. Pregnancy, breast-feeding or intention of becoming pregnant

11. Current or recent alcohol or drug abuse by subject history.

12. Blood donation of more than 473 ml within the last 56 days

13. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

14. Any skin condition that prevents sensor placement on the abdomen (e.g., bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)

15. Known allergy to medical adhesives, e.g. Tegaderm

16. Hematocrit < 38% (males) and < 36% (females)

17. Potassium < 3.4 mmol/L

18. Active enrollment in another clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronnie Aronson, MD

Role: PRINCIPAL_INVESTIGATOR

LMC Endocrinology Centre, Clinical Research Unit

Locations

>LMC Endocrinology Centre, Clinical Research Unit

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

BDT-11-CGM002

Identifier Type: -

Identifier Source: org_study_id