Trial Outcomes & Findings for Hybrid Closed Loop Insulin Delivery System in Hypoglycemia (NCT NCT03215914)
NCT ID: NCT03215914
Last Updated: 2024-10-24
Results Overview
The primary outcome measure will be endogenous glucose production in response to insulin-induced hypoglycemia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
After 6 months of hybrid closed-loop insulin delivery.
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Subjects With Type 1 Diabetes Using MiniMed 670G System
Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
MiniMed 670G system: Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
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|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
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Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hybrid Closed Loop Insulin Delivery System in Hypoglycemia
Baseline characteristics by cohort
| Measure |
Subjects With Type 1 Diabetes Using MiniMed 670G System
n=10 Participants
Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
MiniMed 670G system: Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
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Age, Categorical
>=65 years
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1 Participants
n=93 Participants
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Age, Continuous
|
49 years
STANDARD_DEVIATION 16 • n=93 Participants
|
|
Sex: Female, Male
Female
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7 Participants
n=93 Participants
|
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Sex: Female, Male
Male
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3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
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Region of Enrollment
United States
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10 participants
n=93 Participants
|
|
Endogenous Glucose Produciton
|
.73 [mg/(kgxmin)]
STANDARD_DEVIATION .23 • n=93 Participants
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PRIMARY outcome
Timeframe: After 6 months of hybrid closed-loop insulin delivery.The primary outcome measure will be endogenous glucose production in response to insulin-induced hypoglycemia.
Outcome measures
| Measure |
Subjects With Type 1 Diabetes Using MiniMed 670G System
n=10 Participants
Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
MiniMed 670G system: Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
|
|---|---|
|
Endogenous Glucose Production
|
.66 [mg/(kgxmin)]
Standard Deviation .13
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SECONDARY outcome
Timeframe: After 18 months of hybrid closed-loop insulin delivery.The secondary outcome measure will be endogenous glucose production in response to insulin-induced hypoglycemia.
Outcome measures
| Measure |
Subjects With Type 1 Diabetes Using MiniMed 670G System
n=10 Participants
Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
MiniMed 670G system: Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
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|---|---|
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Endogenous Glucose Production
|
.69 [mg/(kgxmin)]
Standard Deviation .11
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Adverse Events
Subjects With Type 1 Diabetes Using MiniMed 670G System
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects With Type 1 Diabetes Using MiniMed 670G System
n=10 participants at risk
Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
MiniMed 670G system: Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels \< 70 mg/dl.
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|---|---|
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Endocrine disorders
Hypoglycemia
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40.0%
4/10 • Number of events 5 • 18 months
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Infections and infestations
URI
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20.0%
2/10 • Number of events 2 • 18 months
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|
Infections and infestations
Bacterial Infections
|
20.0%
2/10 • Number of events 2 • 18 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place