Outpatient Control-to-Range: System and Monitoring Testing
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 diabetes mellitus, closed loop artificial pancreas
Eligibility Criteria
Inclusion Criteria:
- ≥21 and <65 years old
Clinical diagnosis of type 1 diabetes mellitus:
Criteria for documented hyperglycemia (at least 1 criterion must be met):
- Fasting glucose ≥126 mg/dL - confirmed
- Two-hour OGTT glucose ≥200 mg/dL - confirmed
- HbA1c ≥6.5% documented by history - 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
Criteria for requiring insulin at diagnosis (at least 1 criterion 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 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/her diabetes for at least 1 year
- Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin.
- HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
- Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
- Demonstration of proper mental status and cognition for the study
- Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study
Exclusion Criteria:
- ≥21 and <65 years old
Clinical diagnosis of type 1 diabetes mellitus:
Criteria for documented hyperglycemia (at least 1 criterion must be met):
- Fasting glucose ≥126 mg/dL - confirmed
- Two-hour OGTT glucose ≥200 mg/dL - confirmed
- HbA1c ≥6.5% documented by history - 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
Criteria for requiring insulin at diagnosis (at least 1 criterion 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 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/her diabetes for at least 1 year
- Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin.
- HbA1c between 6.0% - 9.0% as measured with DCA2000 or equivalent device
- Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
- Demonstration of proper mental status and cognition for the study
- Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving DexCom use
- If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study
Sites / Locations
- Sansum Diabetes Research Institute
Arms of the Study
Arm 1
Experimental
Control to Range Testing
Subjects will spend two nights in a non hospital setting while the DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is remotely monitored from an adjacent room. DiAs Diabetes Assistant Wearable Artificial Pancreas Platform is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.