Trial Outcomes & Findings for Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy (NCT NCT01714505)
NCT ID: NCT01714505
Last Updated: 2014-09-09
Results Overview
The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in "risk space." Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes. LBGI \< 2.5 is associated with low risk of hypoglycemia, 2.5 \< LBGI \< 5 is associated with a moderate risk of hypoglycemia and LBGI \> 5 is associated with a high risk of hypoglycemia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
40 hours (x2 admissions)
Results posted on
2014-09-09
Participant Flow
Participant milestones
| Measure |
Open-Loop Then Closed-Loop Control
Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings.
Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.
|
Closed-Loop Then Open-Loop Control
Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.
Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings.
|
|---|---|---|
|
Admission 1 (40 Hours)
STARTED
|
10
|
10
|
|
Admission 1 (40 Hours)
COMPLETED
|
9
|
9
|
|
Admission 1 (40 Hours)
NOT COMPLETED
|
1
|
1
|
|
Admission 2 (40 Hours)
STARTED
|
9
|
9
|
|
Admission 2 (40 Hours)
COMPLETED
|
9
|
9
|
|
Admission 2 (40 Hours)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy
Baseline characteristics by cohort
| Measure |
Open and Closed Loop Control
n=20 Participants
Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.
Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 40 hours (x2 admissions)The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in "risk space." Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes. LBGI \< 2.5 is associated with low risk of hypoglycemia, 2.5 \< LBGI \< 5 is associated with a moderate risk of hypoglycemia and LBGI \> 5 is associated with a high risk of hypoglycemia.
Outcome measures
| Measure |
Closed-loop Control to Range
n=18 Participants
Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
|
Open-Loop CGM-Augmented Insulin Pump Therapy
n=18 Participants
Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
|
|---|---|---|
|
Safety, Low Blood Glucose Index (LBGI)
|
0.64 index score
Standard Deviation 0.72
|
1.12 index score
Standard Deviation 0.77
|
PRIMARY outcome
Timeframe: 40 hours (x 2 admissions)Hypoglycemic episodes are defined as BG \< 3.9mmol/L
Outcome measures
| Measure |
Closed-loop Control to Range
n=18 Participants
Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
|
Open-Loop CGM-Augmented Insulin Pump Therapy
n=18 Participants
Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
|
|---|---|---|
|
Safety, Frequency of Hypoglycemia
|
1.22 hypoglycemic episodes/participant
Standard Deviation 0.4
|
2.39 hypoglycemic episodes/participant
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 40 hours (x2 admissions)Percentage of time in the target range of 3.9-10 mmol/L (70-180 mg/dL).
Outcome measures
| Measure |
Closed-loop Control to Range
n=18 Participants
Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
|
Open-Loop CGM-Augmented Insulin Pump Therapy
n=18 Participants
Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
|
|---|---|---|
|
Efficacy, Time Spent in Target Range
|
66.1 percentage of time spent in range
Standard Deviation 18.6
|
70.7 percentage of time spent in range
Standard Deviation 21.7
|
Adverse Events
Closed-loop Control to Range
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Open-Loop CGM-Augmented Insulin Pump Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Closed-loop Control to Range
n=19 participants at risk
Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.
Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
|
Open-Loop CGM-Augmented Insulin Pump Therapy
n=20 participants at risk
Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
15.8%
3/19 • Number of events 3
|
0.00%
0/20
|
|
Investigations
System Malfunction
|
10.5%
2/19 • Number of events 2
|
0.00%
0/20
|
|
Endocrine disorders
Hyper and Hypoglycemia
|
0.00%
0/19
|
5.0%
1/20 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place