Average Blood Glucose Over the Closed-loop Control Period
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Closed-loop | 164 | 17 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Closed-loop Glucose Control for Automated Management of Type 1 Diabetes
NCT00811317May 2008 to Oct 2009
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
We hypothesize that our integrated closed-loop glucose-control system can provide effective, tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the feasibility of closed-loop BG control.
Experimental
Closed-loop
Type 1 diabetic subjects under closed-loop blood glucose control
Outcomes the sponsor listed as primary.
Average Blood Glucose Over the Closed-loop Control Period
Time frame · 24 hours
Percentage of Time Spent Within 70-180 mg/dl
Time frame · 24 hours
Peak Hyperglycemia Following Each Meal
Time frame · After each of 3 meals
Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals
Time frame · After each of 3 meals
Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target)
Time frame · 24 hours
Percentage of Time Spent With BG < 70 mg/dl
Time frame · 24 hours
Number of Hypoglycemic Events
Time frame · 24 hours
This outcome captures the number of hypoglycemic events that occurred throughout the entire study
Nadir Blood Glucose Level for Each Hypoglycemic Event
Time frame · 24 hours
Percentage of Time Spent With BG > 180 mg/dl
Time frame · 24 hours
Total Insulin Dose
Time frame · 24 hours
Glucagon T-max
Time frame · 24 hours
Time to maximum peak glucagon concentration
Total Glucagon Dose
Time frame · 24 hours
Blood Glucagon Levels
Time frame · 24 hours
Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data
Time frame · 24 hours
Number of Carbohydrate Interventions
Time frame · 24 hours
Number of Participants Achieving a Stable Glucose Response to Insulin Dosing
Time frame · 24 hours
Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals
Time frame · 24 hours
Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard
Time frame · 24 hours
Measuring the mean absolute relative difference (MARD) between the blood glucose measurement and CGM glucose readings, on three different CGM devices: Dexcom, Guardian and Navigator
Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects
Time frame · 24 hours
Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects
Time frame · 24 hours
Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard
Time frame · 24 hours
Mean absolute relative difference (MARD) of CGM and BG glucose readings in hypoglycemia (\< 70 mg/dl) and hyperglycemia (\>180 mg/dl) in three different CGM devices: Dexcom, Navigator and Guardian
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Closed-loop | 164 | 17 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Closed-loop | 61 | 15 |
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Closed-loop | 226.7 | 26.6 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Closed-loop | 38 | 9 |
| Group | Value (percentage of blood glucose measurements) |
|---|---|
| Closed-loop | 6 |
| Group | Value (percentage of time) | Spread |
|---|---|---|
| Closed-loop | 0.35 | 0.33 |
| Group | Value (Number of events) |
|---|---|
| Closed-loop | 2 |
| Group | Value (mg/dl) |
|---|---|
| Closed-loop | 66 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Closed-loopType 1 diabetic subjects under closed-loop blood glucose control Closed-loop: Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target | 0 / 11 | 0 / 11 | 0 / 11 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
PubMed tag: none · 2007
El-Khatib et al. 2007Journal of diabetes science and technologycited by 52
PMID 19888405PMC2771467DOI 10.1177/193229680700100208PUB-19888405
Who could join, as posted.
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