Trial Outcomes & Findings for The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System (NCT NCT03674281)
NCT ID: NCT03674281
Last Updated: 2021-01-12
Results Overview
Percentage of time of blood glucose in range 70-180 mg/dL as measured by the continuous glucose monitor.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
One month during each study period (sensor augmented pump and closed loop control)
Results posted on
2021-01-12
Participant Flow
Participant milestones
| Measure |
Older Adults:Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC)
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.
|
Younger Children: SAP-CLC
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.
|
Parents of Young Children
Parent of Young Children. Parents wore a sleep watch.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Older Adults:Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC)
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.
|
Younger Children: SAP-CLC
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.
|
Parents of Young Children
Parent of Young Children. Parents wore a sleep watch.
|
|---|---|---|---|
|
Overall Study
screen failure
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
3
|
Baseline Characteristics
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
Baseline characteristics by cohort
| Measure |
Older Adults:Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC)
n=15 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.
|
Younger Children: SAP-CLC
n=13 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
SAP: Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
CLC: The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.
|
Parents of Young Children
n=13 Participants
Limited data were obtained on parents of young children and included actigraphy watch.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
9.1 years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 25.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Hemoglobin A1c
|
7 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.8 • n=5 Participants
|
7.6 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.2 • n=7 Participants
|
NA percentage of glycosylated hemoglobin
STANDARD_DEVIATION NA • n=5 Participants
|
7.3 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: One month during each study period (sensor augmented pump and closed loop control)Percentage of time of blood glucose in range 70-180 mg/dL as measured by the continuous glucose monitor.
Outcome measures
| Measure |
Older Adults:Sensor Augmented Pump (SAP)
n=15 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Older Adults: Closed-Loop Control (CLC)
n=15 Participants
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: SAP
n=13 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: CLC
n=13 Participants
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: SAP
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: CLC
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
|---|---|---|---|---|---|---|
|
Percentage of Time of Blood Glucose in Range 70-180 mg/dL
|
69.6 percentage of time
Standard Deviation 14.2
|
79.6 percentage of time
Standard Deviation 7.8
|
50.9 percentage of time
Standard Deviation 12
|
69.2 percentage of time
Standard Deviation 9.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessments will be administered during the final 14 days of each study period (sensor-augmented pump and closed-loop control).Positive Moods were assessed using Ecological Momentary Assessments. Participants were asked a question on positive moods and answered on a Likert scale from 0 to 4 with a higher score indicating more positive mood. Scores were averaged from all evaluable completed assessment that were completed in the final 14 days of each study period.
Outcome measures
| Measure |
Older Adults:Sensor Augmented Pump (SAP)
n=15 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Older Adults: Closed-Loop Control (CLC)
n=15 Participants
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: SAP
n=13 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: CLC
n=13 Participants
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: SAP
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: CLC
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
|---|---|---|---|---|---|---|
|
Ecological Momentary Assessments
|
2.42 score on a scale
Standard Deviation 1.12
|
2.21 score on a scale
Standard Deviation 0.93
|
2.45 score on a scale
Standard Deviation 1.19
|
2.3 score on a scale
Standard Deviation 1.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessments will be made at baseline and at the end of each study SAP (4 weeks) and CLC (4 weeks).Pittsburgh Sleep Quality Index (PSQI): a 10-item questionnaire assessment of sleep quality disturbances over the last month. Individual Items are rated on a 4 point Likert scale ranging from 0 to 3, which are then used to calculate a Global Score which can range from 0 to 21 with higher scores reflecting worse sleep quality. Parents completed the questionnaire for the young children cohort.
Outcome measures
| Measure |
Older Adults:Sensor Augmented Pump (SAP)
n=15 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Older Adults: Closed-Loop Control (CLC)
n=15 Participants
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: SAP
n=15 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: CLC
n=13 Participants
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: SAP
n=13 Participants
SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
Young Children: CLC
n=13 Participants
CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.
|
|---|---|---|---|---|---|---|
|
Sleep Patterns
|
5.86 score on a scale
Standard Deviation 3.01
|
5.71 score on a scale
Standard Deviation 4.23
|
5.50 score on a scale
Standard Deviation 3.11
|
4.38 score on a scale
Standard Deviation 3.18
|
3.54 score on a scale
Standard Deviation 2.6
|
3.62 score on a scale
Standard Deviation 1.71
|
Adverse Events
Older Adults:SAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Older Adults: CLC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Younger Children: SAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Younger Children: CLC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place