Effectiveness of Closed Loop Diabetes Control
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Placebo Comparator: Insulin Alone | 136.9 | 5.0 |
| Active Comparator: Insulin Plus Glucagon | 149.5 | 5.5 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone
NCT00797823Nov 2008 to Sept 2009
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study aims to test an insulin and glucagon delivery algorithm designed to be used in conjunction with a continuous glucose monitoring system. This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas. The insulin and glucagon delivery algorithm is based on the difference between the current blood glucose and the target glucose (proportional error) and the rate of change in blood glucose (derivative error), both adjusted for the recent glucose history. This algorithm is called the Fading Memory Proportional-Derivative (FMPD) Algorithm. The principal investigator of this study has published previous research regarding the use of this algorithm and found it to be well-suited to control blood glucose in type 1 diabetic animals. The addition of glucagon was helpful; better glycemic control with fewer glucose excursions were observed when small intermittent infusions of subcutaneous glucagon were given during times of impending low blood sugar (Ward et al. 2008).
Placebo comparator
Insulin + Placebo
Glycemic control of subject participants was managed by the closed-loop system which delivered insulin and normal saline (instead of glucagon) as a placebo, based upon algorithm calculations.
Active comparator
Insulin + Glucagon
Glycemic control of subject participants was managed by the system which delivered insulin and glucagon based upon algorithm calculations.
Experimental
Pilot Study
Pilot studies designed to assess safety of the system. Includes 6 participants undergoing 7 studies.
Outcomes the sponsor listed as primary.
Effectiveness of Closed Loop Diabetes Control
Time frame · 1 year
Effectiveness of closed loop diabetes control will be measured by mean glucose.
Percent of Time Venous Blood Glucose <70 mg/dl
Time frame · 1 year
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Placebo Comparator: Insulin Alone | 136.9 | 5.0 |
| Active Comparator: Insulin Plus Glucagon | 149.5 | 5.5 |
| Group | Value (percent of time) | Spread |
|---|---|---|
| Placebo Comparator: Insulin Alone | 2.8 | 0.67 |
| Active Comparator: Insulin Plus Glucagon | 1.15 | 0.41 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Insulin + Glucagon -> Insulin + Placebo)This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention). | – | 0 / 4 | 4 / 4 |
| Insulin + Placebo -> Insulin + GlucagonThis group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention). | – | 0 / 4 | 4 / 4 |
| PilotPilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study. | – | 0 / 6 | 1 / 6 |
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