A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Intervention: GBP CGM
Intervention description: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Continuous Glucose Monitor

Summary:

      The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies
      Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1
      diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (>180mg/dL)
      glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels
      when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing
      41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous
      insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal
      is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and
      displays blood sugar (glucose) levels in the body throughout the day and night. The method
      being used to detect blood sugar in the investigational Glucose Binding Protein-Based
      Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by
      commercially available models.

      Some sensors cannot tell the difference between glucose (sugar) and other substances such as
      Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give
      false readings. The GBP CGM is made to only recognize glucose in the body rather than other
      substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect
      the new GBP CGM to be more accurate at detecting low blood sugar levels than the current
      devices.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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):

               1. Fasting glucose ≥126 mg/dL - confirmed

               2. Two-hour oral Glucose Tolerance Tests (OGTT) glucose ≥200 mg/dL - confirmed

               3. HbA1c ≥6.5% documented - confirmed

               4. Random glucose ≥200 mg/dL with symptoms

               5. 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):

               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

          -  Use of an insulin pump to treat his or her diabetes for at least six months prior to
             the study.

          -  Actively using a bolus calculator function with the current insulin pump with
             pre-defined parameters for glucose goal(s), carbohydrate ratio(s), and insulin
             sensitivity factor(s).

          -  Signed informed consent

          -  Age ≥21 and <65 years old

          -  Body mass index between 19 and 30 kg/m2, inclusive

          -  HbA1c ≤11%

        Exclusion Criteria:

          -  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 12 months
             prior to enrollment

          -  Conditions which may increase the risk of induced hypoglycemia such as known coronary
             artery disease, congestive heart failure, history of any cardiac disorder or
             arrhythmia, history of a cerebrovascular event, history of migraines, seizure
             disorder, syncope, adrenal insufficiency, or neurological disease.

          -  Current use of medications containing >4000 mg acetaminophen per day.

          -  Current use of L-Monoamine oxidases (MAO) inhibitors.

          -  Known microvascular (diabetic) complications (other than diabetic non-proliferative
             retinopathy),such as history of laser coagulation, proliferative diabetic retinopathy,
             known diabetic nephropathy (other than microalbuminuria with normal creatinine) or
             neuropathy requiring treatment

          -  Known allergy to eggs

          -  Pregnancy, breast-feeding or intention of becoming pregnant

          -  Current or recent alcohol or drug abuse by patient history.