Type 1 Diabetes Mellitus Clinical Trial
Official title:
Safety and Feasibility of an Insulin Sensitivity-Informed Bolus Calculator in Type 1 Diabetes
NCT number | NCT03709108 |
Other study ID # | 21040 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 19, 2018 |
Est. completion date | March 31, 2019 |
Verified date | May 2019 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-center randomized crossover trial. The investigators will target completion
of 15 adults (age 18-65 years) with Type 1 Diabetes who use an insulin pump. After completion
of the Screening Visit, each subject will participate in a 28-day at home Data Collection
Period while using their personal insulin pump, a personal glucometer, a study CGM, and a
study activity tracker (i.e., Fitbit). This data collection period may be extended to obtain
to gather more days of quality data, if needed per principal investigator judgement.
Once the data has been collected and processed, subjects will participate in two 24-hour
admissions (Experimental and Control Admission) in a semi-controlled environment (i.e.,
hotel), performed in the assigned random order. During both admissions, subjects will use the
personal insulin pump and glucometer, and a study CGM. The exercise session will consist of
three 15-minute bouts of moderate-intensity exercise (i.e., stationary bicycle). Subjects
will be provided a controlled dinner; the SI-informed bolus calculator will be used in the
Experimental Admission while standard therapy will be used in the Control Admission. Subjects
will then be observed overnight and discharged in the following morning.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | DexCom, Inc., Juvenile Diabetes Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and feasibility of the SI-informed bolus calculator: Low Blood Glucose Index | Safety and feasibility of the SI-informed bolus calculator as measured by overall and postprandial occurrence of hypoglycemia quantified using the Low Blood Glucose Index (LBGI) computed from CGM data. LBGI is a previously introduced glucose variability measure and strong predictor of severe hypoglycemia, designed to aggregate the frequency and extent of low blood glucose events into a single number. By this definition, a higher LBGI may indicate a large number of mild hypoglycemic events, a small number of significant events, or a combination of both. As a higher LBGI indicates higher exposure to hypoglycemia, LBGI is expected to be better (i.e., lower) when the optimized bolus calculator is used, as compared to standard therapy. | LBGI will be assessed in the postprandial period following the controlled dinner meal (up to 4 hours following dinner) and overnight (e.g., from 11PM until 6AM), and will be compared between the two admissions. |
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