Diabetes, Hyperglycemia
Conditions
Keywords
closed loop glucose control, intensive care glucose control
Brief summary
The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery
Detailed description
The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm
Interventions
DEVICEglucose and insulin infusions
combined algorithm directed glucose and insulin infusion with 5 minute blood glucose measurements to direct glucose control; regular insulin and glucose are infused intravenously as adjusted by the algorithm without manual intervention in the group of diabetic individuals under study to adjust the glucose level to a target range of 80-180 mg/dl
Sponsors
Admetsys Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Insulin and glucose infusion in closed loop control; intervention is glucose control with insulin and glucose infusion
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9% * glucose at time of study \> 150 mg/dl
Exclusion criteria
* pregnancy * renal or hepatic disease * corticosteroids * poor intravenous access * anemia * electrolyte abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glucose control in target range | data will be evaluated within 6 months after completion of all 40 studies | blood glucose measurements in target range (80-125 mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hypoglycemia | data will be evaluated within 6 months after all 40 studies are completed | blood glucose \<70 mg/dl |
Countries
United States
Outcome results
None listed