Feasibility Study of a Modular Control to Range System in Type 1 Diabetes Mellitus (MDB003)
In this protocol the investigators plan to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). The protocol is designed to challenge the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state. This system is designed to both
- monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;
- predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.
The investigators plan to enroll 12 adult Type 1 Diabetes Mellitus (T1DM) patients (expected retention 10/12) and compare glucose control performances under two treatments: standard vs. the new insulin management system. The protocol will include a total of 6 admissions per subject (4 out-patients and 2 in-patients): screening, effort test, CGM insertion 1, inpatient 1, CGM insertion 2, and inpatient 2. During the 24h inpatient admissions, the patients will be challenged with 30 minutes of mild exercise and 3 meals, insulin coverage of these events will vary depending on the chosen treatment, each subject will be exposed to both studied treatments (repeated measure design).The order of treatment during the inpatient admissions will be randomized.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Feasibility Study of a Modular Control to Range System in T1DM|
- Number of hypoglycemic events below 70 mg/dL per patient per day [ Time Frame: 24h ] [ Designated as safety issue: Yes ]Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemia symptoms
- Percent time in euglycemia [ Time Frame: 24h ] [ Designated as safety issue: No ]Percent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl
- Mean glucose [ Time Frame: 24h ] [ Designated as safety issue: No ]Average plasma glucose concentration in mg/dl
|Study Start Date:||October 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Closed Loop Control (CLC)
The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:
Device: Closed Loop Control (CLC)
In this study, the researchers compared the management of diabetes during physical activity and meals with the closed-loop system developed at the University of Virginia. This Control to Range System uses two DexComTM Seven Continuous Glucose Monitor, a computer containing an investigational control algorithm (well-defined instructions that are expressed in mathematical equations), and an OmniPod Insulin Management System, a portable subcutaneous (under the skin) insulin pump. During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms.
Placebo Comparator: Open Loop
The subject were in charge of their insulin treatment.
Device: Open Loop
This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418703
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22904|
|Principal Investigator:||Marc D Breton, Ph.D.||University of Virgnia - School of Medicine, Psychiatry and Neurobehavioral Sciences|