USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D

Inclusion Criteria

Clinical diagnosis of type 1 diabetes for at least 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 ≥126 mg/dL (confirmed)
• Two-hour oral glucose tolerance test (OGTT) glucose ≥200 mg/dL (confirmed)
• HbA1c ≥6.5% (confirmed)
• Random glucose ≥200 mg/dL with symptoms
• No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes or in the opinion of the investigator participant has history consistent with type 1 diabetes.

Criteria for requiring insulin at diagnosis (at least 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 required 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 thereafter
• Use of insulin for the last 12 months or more
• Use of an insulin infusion pump for the last 6 months or longer
• Age 12-70 years old
• HbA1c 40 as assessed from Self-Monitoring Blood Glucose (SMBG) readings from the prior month. Subject must have a glucometer that can be downloaded for this assessment. The subjects may alternatively provide a spreadsheet of their past 30 days of blood glucose values.
• Low Blood Glucose Index (LBGI) >2.5 as assessed from SMBG from the prior month or LBGI >1.1 as assessed from 1 week of CGM readings from the prior three weeks. Subject must have a glucometer or CGM that can be downloaded for this assessment. For the glucometer data, the subjects may alternatively provide a spreadsheet of their past 30 days of blood glucose values.
• Subject reports no recognition of hypoglycemia until the glucose is 3 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
• Abnormal renal function test results (estimated Glomerular filtration rate (GFR) 10 mIU/L); testing required within 3 months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
• Current or recent abuse of alcohol or recreational drugs by patient history
• Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)
• Any skin condition in the area of insertion that prevents safe sensor or pump placement (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
• Diagnosed with celiac disease and not currently following a gluten free diet
• 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
• Current use of any of the following drugs and supplements:
• Any medication being taken to lower blood glucose, such as Pramlintide, Metformin, Glucagon-like peptide-1 (GLP-1) Analogs such as Liraglutide, and nutraceuticals intended to lower blood glucose
• Beta blockers
• Oral glucocorticoids
• Pseudoephedrine
• Any other medication that the investigator believes is a contraindications to the subject's participation