Trial Outcomes & Findings for Use of the Guardian™ Connect System With Smart Connected Devices (NCT NCT04809285)
NCT ID: NCT04809285
Last Updated: 2024-12-10
Results Overview
The overall mean percentage of time in hypoglycemia (SG \< 70 mg/dL)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
217 participants
Primary outcome timeframe
Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
Results posted on
2024-12-10
Participant Flow
All subjects participated for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older participated for up to 9 months (Phase 2). All subjects wore the Guardian Connect system (real-time CGM) continuously and used smart insulin pens or insulin pens with smart caps for multiple daily injections and continued their standard therapy throughout the duration of the study.
Participant milestones
| Measure |
Guardian™ Connect System, InPen™ Basal Smart Cap, and Smart Insulin Pens
All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app: Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
|
|---|---|
|
Phase 1
STARTED
|
208
|
|
Phase 1
COMPLETED
|
168
|
|
Phase 1
NOT COMPLETED
|
40
|
|
Phase 2
STARTED
|
67
|
|
Phase 2
COMPLETED
|
60
|
|
Phase 2
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Guardian™ Connect System, InPen™ Basal Smart Cap, and Smart Insulin Pens
All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app: Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
|
|---|---|
|
Phase 1
Lost to Follow-up
|
6
|
|
Phase 1
Protocol Violation
|
2
|
|
Phase 1
Physician Decision
|
3
|
|
Phase 1
Withdrawal by Subject
|
29
|
|
Phase 2
Protocol Violation
|
3
|
|
Phase 2
Withdrawal by Subject
|
4
|
Baseline Characteristics
One subject (out of the 208 enrolled) did not provide this information during their study visit.
Baseline characteristics by cohort
| Measure |
Guardian™ Connect System, InPen™ Basal Smart Cap, and Smart Insulin Pens
n=208 Participants
All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study.
Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app: Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. The subject's insulin delivery, sleep, physical activity (as applicable), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
|
|---|---|
|
Age, Continuous
|
37.3 Years
STANDARD_DEVIATION 17.8 • n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Sex: Female, Male
Female
|
97 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Sex: Female, Male
Male
|
110 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Race/Ethnicity, Customized
Race · White
|
154 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Race/Ethnicity, Customized
Race · Asian
|
13 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native, Black or African American, White
|
2 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native, White
|
1 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
28 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=207 Participants • One subject (out of the 208 enrolled) did not provide this information during their study visit.
|
|
Region of Enrollment
United States
|
208 Participants
n=208 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2Population: The number of participants analyzed reflects the number of subjects for which any data were available.
The overall mean percentage of time in hypoglycemia (SG \< 70 mg/dL)
Outcome measures
| Measure |
Phase 1
n=192 Participants
Subjects who participated in Phase 1 of the study.
|
Phase 2
n=63 Participants
Subjects who participated in Phase 2 of the study (some subjects 18 years of age or older who participated for up to 9 months after participating in Phase 1).
|
|---|---|---|
|
Percentage of Time in Hypoglycemia
|
3.1 percentage of time
Standard Deviation 3.4
|
2.7 percentage of time
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2Population: The number of participants analyzed reflects the number of subjects for which any data were available.
The overall mean percentage of time in euglycemia (SG 70-180 mg/dL)
Outcome measures
| Measure |
Phase 1
n=192 Participants
Subjects who participated in Phase 1 of the study.
|
Phase 2
n=63 Participants
Subjects who participated in Phase 2 of the study (some subjects 18 years of age or older who participated for up to 9 months after participating in Phase 1).
|
|---|---|---|
|
Percentage of Time in Euglycemia
|
59.5 percentage of time
Standard Deviation 20.2
|
58.7 percentage of time
Standard Deviation 20.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2Population: The number of participants analyzed reflects the number of subjects for which any data were available.
The overall mean percentage of time in hyperglycemia (SG \> 180 mg/dL)
Outcome measures
| Measure |
Phase 1
n=192 Participants
Subjects who participated in Phase 1 of the study.
|
Phase 2
n=63 Participants
Subjects who participated in Phase 2 of the study (some subjects 18 years of age or older who participated for up to 9 months after participating in Phase 1).
|
|---|---|---|
|
Percentage of Time in Hyperglycemia
|
37.5 percentage of time
Standard Deviation 20.9
|
38.7 percentage of time
Standard Deviation 20.7
|
Adverse Events
Phase 1
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase 2
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1
n=208 participants at risk
Subjects who participated in Phase 1 of the study.
|
Phase 2
n=67 participants at risk
Subjects who participated in Phase 2 of the study (some subjects 18 years of age or older who participated for up to 9 months after participating in Phase 1).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/208 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
1.5%
1/67 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/208 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
1.5%
1/67 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
1.5%
1/67 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Cardiac disorders
Myocardial infarction
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
General disorders
Hypothermia
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.96%
2/208 • Number of events 2 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.96%
2/208 • Number of events 2 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Nervous system disorders
Encephalopathy
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Psychiatric disorders
Substance abuse
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Renal and urinary disorders
End stage renal disease
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
Other adverse events
| Measure |
Phase 1
n=208 participants at risk
Subjects who participated in Phase 1 of the study.
|
Phase 2
n=67 participants at risk
Subjects who participated in Phase 2 of the study (some subjects 18 years of age or older who participated for up to 9 months after participating in Phase 1).
|
|---|---|---|
|
General disorders
Medical device pain
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
General disorders
Medical device site dermatitis
|
1.9%
4/208 • Number of events 4 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
General disorders
Medical device site discolouration
|
0.96%
2/208 • Number of events 2 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
General disorders
Medical device site haemorrhage
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
General disorders
Medical device site irritation
|
3.4%
7/208 • Number of events 7 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
General disorders
Medical device site pruritus
|
1.9%
4/208 • Number of events 4 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
General disorders
Medical device site rash
|
1.4%
3/208 • Number of events 3 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
General disorders
Medical device site vesicles
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.96%
2/208 • Number of events 2 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.48%
1/208 • Number of events 2 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.48%
1/208 • Number of events 1 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
0.00%
0/67 • Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60