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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
Overnight Closed-Loop Control (CLC) is run on the DiAs which is a medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump. The cell phone runs the CLC and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range.
The subject will be on their home insulin pump (UVA) or study pump (Italy) and using a CGM per their usual care.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Time in Range Overnight
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.
Time frame: 5 consecutive nights
Evaluating the Risk for Hypoglycemia as Measured by the Low Blood Glucose Index
A secondary goal of the cross-over trial is to evaluate the ability of the CLC to prevent hypoglycemia with the outcome measure of Low Blood Glucose Index. Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk (there is no maximum score). Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale. The calculation of LBGI uses all available CGM values during the 5 consecutive nights of study to create one index. For the SAP group, the mean value lies outside the interquartile range due to outlying values that contribute to increasing the mean.
Time frame: 5 consecutive nights
Time Within Target Range
Closed loop control will improve the time spent within the target range of 70-180 mg/dl (computed from retrofitted CGM data).
Time frame: 5 consecutive nights
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.