Trial Outcomes & Findings for Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System (NCT NCT01148862)
NCT ID: NCT01148862
Last Updated: 2017-03-30
Results Overview
Duration (minutes) of induced hypoglycemia (YSI \< 70 mg/dL)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
approximately 8 hours per induction experiment
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
LGS on First, Then LGS Off
LGS on first, then LGS off group will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature turned 'ON' first, then LGS turned 'OFF' after crossing over
|
LGS Off First, Then LGS on
LGS off first, then LGS on group will wear the MiniMed Paradigm® X54 System with Low Glucose Suspend (LGS) turned 'OFF' first, then LGS turned on 'ON' after crossing over
|
|---|---|---|
|
First Intervention
STARTED
|
25
|
25
|
|
First Intervention
COMPLETED
|
25
|
25
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 2 Weeks
STARTED
|
25
|
25
|
|
Washout Period of 2 Weeks
COMPLETED
|
25
|
25
|
|
Washout Period of 2 Weeks
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
25
|
25
|
|
Second Intervention
COMPLETED
|
25
|
23
|
|
Second Intervention
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
LGS on First, Then LGS Off
LGS on first, then LGS off group will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature turned 'ON' first, then LGS turned 'OFF' after crossing over
|
LGS Off First, Then LGS on
LGS off first, then LGS on group will wear the MiniMed Paradigm® X54 System with Low Glucose Suspend (LGS) turned 'OFF' first, then LGS turned on 'ON' after crossing over
|
|---|---|---|
|
Second Intervention
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=50 Participants
Includes groups randomized to LGS on first and LGS off first
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 8 hours per induction experimentDuration (minutes) of induced hypoglycemia (YSI \< 70 mg/dL)
Outcome measures
| Measure |
LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'
n=50 Participants
LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
|
LGS Off: Without Low Glucose Suspend (LGS) Feature
n=50 Participants
LGS off: Without Low Glucose Suspend (LGS) feature
|
|---|---|---|
|
The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.
|
138.5 minutes
Standard Deviation 76.68
|
170.7 minutes
Standard Deviation 75.91
|
PRIMARY outcome
Timeframe: approximately 8 hours per induction experimentSeverity (Milligrams per Deciliter) of induced hypoglycemia (YSI \< 70 Milligrams per Deciliter) is defined as 70 Milligrams per Deciliter minus absolute lowest blood sugar level
Outcome measures
| Measure |
LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'
n=50 Participants
LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
|
LGS Off: Without Low Glucose Suspend (LGS) Feature
n=50 Participants
LGS off: Without Low Glucose Suspend (LGS) feature
|
|---|---|---|
|
The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia.
|
10.5 Milligrams per Deciliter
Standard Deviation 5.72
|
12.5 Milligrams per Deciliter
Standard Deviation 5.69
|
Adverse Events
LGS Off: Without Low Glucose Suspend (LGS) Feature
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LGS Off: Without Low Glucose Suspend (LGS) Feature
n=50 participants at risk
|
LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'
n=50 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Dental Discomfort
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
General disorders
Pain
|
4.0%
2/50 • Number of events 2 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
General disorders
Application Site Bleeding
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Gastrointestinal Infection
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Fungal infection
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Herpes zoster
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Tonsillitis
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Urinary Tract Infection
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Upper Respiratory Track Infection
|
4.0%
2/50 • Number of events 2 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • Number of events 2 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Injury, poisoning and procedural complications
Limb Injury
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Injury, poisoning and procedural complications
Skeletal Injury
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Renal and urinary disorders
Ketonuria
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Surgical and medical procedures
Endodontic procedure
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
|
Infections and infestations
Sinusitis
|
2.0%
1/50 • Number of events 1 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
0.00%
0/50 • Severe adverse event data and adverse event data were collected during the 35-46 days of study duration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place