Trial Outcomes & Findings for USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D (NCT NCT02302963)
NCT ID: NCT02302963
Last Updated: 2022-10-07
Results Overview
Change in hypoglycemia during the study on USS Virginia versus Sensor Augmented Pump (SAP) as assessed by Low Blood Glucose Index (LBGI) from Continuous Glucose Monitoring (CGM) during 1 week of baseline blinded use versus during the last week of intervention. The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI will be higher for someone with a higher percentage of low blood glucose readings or more extreme hypoglycemic episodes. Reference: Kovatchev BP. Metrics for Glycaemic Control: from HbA1c to Continuous Glucose Monitoring. Nature Reviews Endocrinology 2017; 13: 425-436. PMID: 28304392
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
2 weeks total: one week of baseline blinded use to compute LBGI-Pre versus use during the last week of intervention to compute LBGI-Post
Results posted on
2022-10-07
Participant Flow
85 subjects consented; 20 didn't meet eligibility criteria \& 21 subjects withdrew/dropped (18 prerandomization, 1 control, 2 exp). Reasons for withdrawal included scheduling conflicts (5), travel cost (1), interest in a different CLC trial (2), dislike of DiAs (1), alarm fatigue (1), steroid injection (1), and loss communication (10). 44 subjects completed. CGM data missing for 2 of the 44 subjects (1 control, 1 exp); therefore, 42 subjects included in final analysis.
After study eligibility was met, subjects completed 1 week of baseline blinded CGM and SMBG at least four times daily. If LBGI \>1.1 was confirmed by blinded CGM, the subject was randomized to USS Virginia AP experimental treatment or sensor-augmented pump control treatment.
Participant milestones
| Measure |
AP System (DiAs or inControl) With USS Virginia
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then proceed through 7 weeks of training and use of the AP System with USS Virginia and study pump. The inpatient testing will be repeated after wearing the AP System at home.
AP System (DiAs or inControl) with USS Virginia: Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
|
Sensor-Augmented Pump Therapy
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then wear a continuous glucose monitor and their own insulin pump at home for 5 weeks. The inpatient testing will be repeated at the completion of the 5 weeks at home.
Sensor-Augmented Pump Therapy (placebo): Subject will participate in 5 weeks use of CGM and personal insulin pump at home.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
AP System (DiAs or inControl) With USS Virginia
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then proceed through 7 weeks of training and use of the AP System with USS Virginia and study pump. The inpatient testing will be repeated after wearing the AP System at home.
AP System (DiAs or inControl) with USS Virginia: Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
|
Sensor-Augmented Pump Therapy
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then wear a continuous glucose monitor and their own insulin pump at home for 5 weeks. The inpatient testing will be repeated at the completion of the 5 weeks at home.
Sensor-Augmented Pump Therapy (placebo): Subject will participate in 5 weeks use of CGM and personal insulin pump at home.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Steroid injection
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
Baseline characteristics by cohort
| Measure |
AP System (DiAs or inControl) With USS Virginia
n=22 Participants
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then proceed through 7 weeks of training and use of the AP System with USS Virginia and study pump. The inpatient testing will be repeated after wearing the AP System at home.
AP System (DiAs or inControl) with USS Virginia: Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
|
Sensor-Augmented Pump Therapy
n=22 Participants
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then wear a continuous glucose monitor and their own insulin pump at home for 5 weeks. The inpatient testing will be repeated at the completion of the 5 weeks at home.
Sensor-Augmented Pump Therapy (placebo): Subject will participate in 5 weeks use of CGM and personal insulin pump at home.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 3.3 • n=93 Participants
|
38.0 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
38.2 years
STANDARD_DEVIATION 3.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 weeks total: one week of baseline blinded use to compute LBGI-Pre versus use during the last week of intervention to compute LBGI-PostChange in hypoglycemia during the study on USS Virginia versus Sensor Augmented Pump (SAP) as assessed by Low Blood Glucose Index (LBGI) from Continuous Glucose Monitoring (CGM) during 1 week of baseline blinded use versus during the last week of intervention. The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI will be higher for someone with a higher percentage of low blood glucose readings or more extreme hypoglycemic episodes. Reference: Kovatchev BP. Metrics for Glycaemic Control: from HbA1c to Continuous Glucose Monitoring. Nature Reviews Endocrinology 2017; 13: 425-436. PMID: 28304392
Outcome measures
| Measure |
AP System (DiAs or inControl) With USS Virginia
n=21 Participants
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then proceed through 7 weeks of training and use of the AP System with USS Virginia and study pump. The inpatient testing will be repeated after wearing the AP System at home.
AP System (DiAs or inControl) with USS Virginia: Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
|
Sensor-Augmented Pump Therapy
n=21 Participants
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then wear a continuous glucose monitor and their own insulin pump at home for 5 weeks. The inpatient testing will be repeated at the completion of the 5 weeks at home.
Sensor-Augmented Pump Therapy (placebo): Subject will participate in 5 weeks use of CGM and personal insulin pump at home.
|
|---|---|---|
|
Change in Hypoglycemia During Closed Loop Control (Assessed by Low Blood Glucose Index [LBGI])
LBGI (after 1 week of blinded CGM)
|
2.51 low blood glucose index
Standard Deviation 1.17
|
2.1 low blood glucose index
Standard Deviation 1.05
|
|
Change in Hypoglycemia During Closed Loop Control (Assessed by Low Blood Glucose Index [LBGI])
LBGI (last week of intervention after 5 weeks of study participation)
|
1.28 low blood glucose index
Standard Deviation 0.5
|
1.79 low blood glucose index
Standard Deviation 0.98
|
Adverse Events
AP System (DiAs or inControl) With USS Virginia
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sensor-Augmented Pump Therapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AP System (DiAs or inControl) With USS Virginia
n=22 participants at risk
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then proceed through 7 weeks of training and use of the AP System with USS Virginia and study pump. The inpatient testing will be repeated after wearing the AP System at home.
|
Sensor-Augmented Pump Therapy
n=22 participants at risk
Subject will complete an 8-hour inpatient assessment of hypoglycemia counterregulation. Subject will then wear a continuous glucose monitor and their own insulin pump at home for 5 weeks. The inpatient testing will be repeated at the completion of the 5 weeks at home.
|
|---|---|---|
|
Endocrine disorders
Moderate hyperglycemia, mild ketonemia
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
0.00%
0/22 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Endocrine disorders
Moderate hyperglycemia, moderate ketonemia
|
13.6%
3/22 • Number of events 3 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
9.1%
2/22 • Number of events 2 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Endocrine disorders
Mild ketonemia
|
9.1%
2/22 • Number of events 2 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
0.00%
0/22 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Musculoskeletal and connective tissue disorders
Soccer injury
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
0.00%
0/22 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory illness
|
9.1%
2/22 • Number of events 2 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
0.00%
0/22 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Skin and subcutaneous tissue disorders
IV Site Bruising
|
9.1%
2/22 • Number of events 2 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Musculoskeletal and connective tissue disorders
Arm fracture from fall
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
0.00%
0/22 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Infections and infestations
Fever
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Infections and infestations
Ear infection
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
0.00%
0/22 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
|
Nervous system disorders
Vasovagal event
|
4.5%
1/22 • Number of events 1 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
4.5%
1/22 • Number of events 2 • Up to 14 weeks of study participation (visit 2 through visit 6)
|
Additional Information
Director
University of Virginia Center for Diabetes Technology
Phone: 434-924-5592
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place