Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Sue Brown
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Time in Range Overnight
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to use an Advisory/Automated Adaptive (AAA) or Closed-Loop Control (CLC) system for insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. A component of this study evaluated AAA or CLC Control overnight only in 5 consecutive overnights in a cross-over trial with sensor-augmented pump therapy occurring prior to or following CLC overnight. Another component of this study planned evaluating if the AAA Control system run on the Diabetes Assistant (DiAs) system can prevent hypoglycemia during and following exercise more efficiently during a 40 hour trial this part of the trial was not conducted due to a preference for overnight only configuration in pilot testing. This protocol represents a culmination of prior clinical trials in development of this AAA system and benefits from the synthesis of those components.
Detailed Description
The primary goal of this study is to test an Advisory/Automated Adaptive (AAA) or CLC Control system, which includes three interacting control modules: * Module 1 - Automated Safety Supervision (SSM) responsible for prevention of hypoglycemia, which can be adapted (individualized) with prior data for each subject; * Module 2 - Advisory Module (AM) responsible for pre-meal boluses and postprandial corrections, which can be adapted (individualized) with prior data for each subject; * Module 3 -- Automated Basal Rate Module (BRM) responsible for augmentation of basal rate to compensate for changes in insulin sensitivity, particularly overnight (e.g. dawn phenomenon), which can be adapted with prior data for each subject. Daytime control (40hour studies) includes all 3 modules (n=36 were not recruited). Overnight only closed loop control (5 consecutive overnights) includes Module 1 and 3 (n=5-7).
Investigators
Sue Brown
Principal Investigator
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •≥21 and \<65 years old.
- •Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met.
- •o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test glucose ≥200 mg/dL - confirmed iii. Hemoglobin A1C (HbA1c) ≥6.5% documented - confirmed iv. Random glucose ≥200 mg/dL with symptoms v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- •o Criteria for requiring insulin at diagnosis (1 must be met): i. Participant required insulin at diagnosis and continually thereafter ii. 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 iii. 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.
- •Familiarity with a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate ratio, insulin sensitivity factor (ISF), target glucose and active insulin.
- •HbA1c \<9% 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 24 hours prior to and during CGM use.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time in Range Overnight
Time Frame: 5 consecutive nights
For subjects participating in consecutive overnight control, will assess time in range (80-140mg/dL) overnight in closed loop control compared to sensor-augmented pump therapy.
Secondary Outcomes
- Evaluating the Risk for Hypoglycemia as Measured by the Low Blood Glucose Index(5 consecutive nights)
- Time Within Target Range(5 consecutive nights)