Trial Outcomes & Findings for Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform (NCT NCT02750267)
NCT ID: NCT02750267
Last Updated: 2017-07-24
Results Overview
All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
COMPLETED
NA
12 participants
68 hours
2017-07-24
Participant Flow
Participant milestones
| Measure |
Group A- Home Care Before Closed-Loop Control
In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Group B- Closed-Loop Control Before Home Care
Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Overall Study
STARTED
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6
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6
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Overall Study
COMPLETED
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6
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6
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
Baseline characteristics by cohort
| Measure |
Group A- Home Care Before Closed-Loop Control
n=6 Participants
In this randomized, cross-over study, the intervention involves blood glucose control using a Closed Loop system run by the Diabetes Assistant (DiAs) during a stay at a Research House/Hotel. All subjects will have blood glucose data compared between their usual diabetes care (at home, using home insulin pump) and this Closed-Loop care (at Research House/Hotel using the DiAs system). Subjects who are randomized to Group A will have home care evaluated before the Research House/Hotel admission. Subjects in this arm will participate in CGM training and data collection prior to the Research House/Hotel admission.
Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Group B- Closed-Loop Control Before Home Care
n=6 Participants
Group B is identical to Group A with the exception that usual diabetes care (at home, using home insulin pump) will be evaluated after the Research House/Hotel admission. Subjects who are randomized to Group B will participate in CGM training and data collection after the Research House/Hotel admission. As with Group A, all subjects will use Diabetes Assistant (DiAs) with Closed-Loop during the admission.
Diabetes Assistant (DiAs) with Closed-Loop: All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
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Total
n=12 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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7 years
n=5 Participants
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7 years
n=7 Participants
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7 years
n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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3 Participants
n=7 Participants
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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3 Participants
n=7 Participants
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6 Participants
n=5 Participants
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HbA1c
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7.7 percentage of HbA1C
n=5 Participants
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7.6 percentage of HbA1C
n=7 Participants
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7.7 percentage of HbA1C
n=5 Participants
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Diabetes Duration
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4.9 years
n=5 Participants
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3.3 years
n=7 Participants
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3.7 years
n=5 Participants
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PRIMARY outcome
Timeframe: 68 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
| Measure |
Home Care (Pump+CGM)
n=12 Participants
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
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Diabetes Assistant (DiAs) With Closed-Loop Control
n=12 Participants
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
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|---|---|---|
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Percent of Sensor Glucose Readings Between 70-180 mg/dL
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46.9 percentage of time in range
Standard Deviation 2.7
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73.1 percentage of time in range
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: 68 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
| Measure |
Home Care (Pump+CGM)
n=12 Participants
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
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Diabetes Assistant (DiAs) With Closed-Loop Control
n=12 Participants
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
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|---|---|---|
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Percent of Time Sensor Glucose Readings Are <70 mg/dL
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1.6 percentage of time below 70 mg/dL
Standard Deviation 1.2
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1.1 percentage of time below 70 mg/dL
Standard Deviation 1.1
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SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 68 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
| Measure |
Home Care (Pump+CGM)
n=12 Participants
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
|
Diabetes Assistant (DiAs) With Closed-Loop Control
n=12 Participants
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
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|---|---|---|
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Percent of Time Sensor Glucose Readings Are >180 mg/dL
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51.5 percentage of time above 180 mg/dL
Standard Deviation 0.8
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25.8 percentage of time above 180 mg/dL
Standard Deviation 2.8
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SECONDARY outcome
Timeframe: 68 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
| Measure |
Home Care (Pump+CGM)
n=12 Participants
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
|
Diabetes Assistant (DiAs) With Closed-Loop Control
n=12 Participants
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
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|---|---|---|
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Percent of Time Sensor Glucose Readings Are >250 mg/dL
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20.8 percentage of time above 250 mg/dL
Standard Deviation 9.9
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6.3 percentage of time above 250 mg/dL
Standard Deviation 5.4
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SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 68 hoursAll subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
| Measure |
Home Care (Pump+CGM)
n=12 Participants
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
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Diabetes Assistant (DiAs) With Closed-Loop Control
n=12 Participants
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
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|---|---|---|
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Mean BG (as Measured by CGM)
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190 mg/dL
Standard Deviation 7.4
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152 mg/dL
Standard Deviation 4.2
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SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 72 hoursAll subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 68 hoursAll subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.
Outcome measures
| Measure |
Home Care (Pump+CGM)
n=12 Participants
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
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Diabetes Assistant (DiAs) With Closed-Loop Control
n=12 Participants
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission.
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|---|---|---|
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Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL
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4.0 events per subject, glucometer <70mg/dL
Standard Deviation 1.0
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3.3 events per subject, glucometer <70mg/dL
Standard Deviation 1.0
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SECONDARY outcome
Timeframe: 72 hoursAll subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.
Outcome measures
Outcome data not reported
Adverse Events
Home Care (Pump+CGM)
Diabetes Assistant (DiAs) With Closed-Loop Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Home Care (Pump+CGM)
n=12 participants at risk
All 12 subjects completed 68 hours of usual, home care using their home insulin pumps and a study CGM. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
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Diabetes Assistant (DiAs) With Closed-Loop Control
n=12 participants at risk
All 12 subjects used the DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a 68 hour Hotel admission. The 6 subjects in Group A completed the home care portion before the Hotel admission, and the 6 subjects in Group B completed the home care portion after the Hotel admission.
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Sore Knee
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0.00%
0/12 • Adverse event data was collect over two 72 hour periods for each subject. Over the entire study, adverse events were collected over a 216 hour period (Group A's 72 hr home period, 72 hr hotel period, Group B's 72 hr home period).
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8.3%
1/12 • Number of events 1 • Adverse event data was collect over two 72 hour periods for each subject. Over the entire study, adverse events were collected over a 216 hour period (Group A's 72 hr home period, 72 hr hotel period, Group B's 72 hr home period).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place