Safety and Feasibility of an Insulin Sensitivity-Informed Bolus Calculator in Type 1 Diabetes

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Continuous Glucose Monitor, Insulin Sensitivity, Exercise Read More

Inclusion Criteria:

1. Type 1 diabetes for at least 12 months
2. Current use of an insulin pump for at least 12 months
3. Current or historical use of a CGM system for at least 6 months
4. Age ≥18 to ≤65 years old
5. HbA1c <8.5% at screening; if HbA1c <6.0% then total daily insulin must be ≥0.5 U/kg
6. For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study
7. Willingness to use the same set of insulin therapy parameters (i.e., basal rate, insulin-to-carbohydrate ratio, correction factor) during both admissions
8. Willingness to upload data during the study
9. An understanding of and willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

1. Diabetes ketoacidosis (DKA) in the 6 months prior to enrollment
2. Clinically significant electrocardiogram (ECG) found at Screening as determined by the study medical physician
3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
4. Currently being treated for a seizure disorder
5. Coronary artery disease or heart failure, unless written clearance is received from a cardiologist or primary care provider and documentation of a negative stress test within the year
6. History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
7. Cystic fibrosis
8. Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures
9. Abnormal liver function test results (Transaminase >2 times the upper limit of normal)
10. Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2)
11. Uncontrolled thyroid disease (TSH undetectable or >10 mIU/L)

12. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

    • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's care companion
    • Presence of a known adrenal disorder
    • 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
13. Abuse of alcohol or recreational drugs
14. Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
15. Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg)
16. 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
17. Basal Rate <0.01 units/hour
18. Inability to be physically active for more than 30 minutes per day
19. Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility)
20. Current enrollment in another intervention clinical trial

List any restrictions on use of other drugs or treatments:

1. Medications being taken to lower blood glucose, such as Pramlintide, Metformin, GLP-1 Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
2. Any other medication that the investigator believes is a contraindication to the subject's participation