Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 100 of 1007 for:    Area Under Curve AND insulin

Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature (ASPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01497938
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Device: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature
Device: Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump
Enrollment 247
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Glucose Suspend Feasure (LGS) Control Arm
Hide Arm/Group Description

According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study

Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low.

The Low Glucose Suspend feature will not be available to subjects in the control arm

Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low.

Period Title: Overall Study
Started 121 126
Completed 116 124
Not Completed 5 2
Reason Not Completed
Adverse Event             0             1
Physician Decision             0             1
Withdrawal by Subject             4             0
Device Violation             1             0
Arm/Group Title Low Glucose Suspend Feature (LGS) Control Arm Total
Hide Arm/Group Description

According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study

Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low.

The Low Glucose Suspend feature will not be available to subjects in the control arm

Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low.

Total of all reporting groups
Overall Number of Baseline Participants 121 126 247
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 126 participants 247 participants
<=18 years
4
   3.3%
5
   4.0%
9
   3.6%
Between 18 and 65 years
110
  90.9%
114
  90.5%
224
  90.7%
>=65 years
7
   5.8%
7
   5.6%
14
   5.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 126 participants 247 participants
41.6  (12.83) 44.8  (13.82) 43.3  (13.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 126 participants 247 participants
Female
75
  62.0%
76
  60.3%
151
  61.1%
Male
46
  38.0%
50
  39.7%
96
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 121 participants 126 participants 247 participants
121 126 247
1.Primary Outcome
Title Change in A1C From Baseline to End of Study Participation
Hide Description The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation.
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' Group B Without Low Glucose Suspend (LGS) Feature
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 116 124
Mean (Standard Deviation)
Unit of Measure: Percent
0.00  (0.44) -0.04  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A With Low Glucose Suspend (LGS) Feature Turned 'ON', Group B Without Low Glucose Suspend (LGS) Feature
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments pre-specified non-inferiority margin of 0.4% was used for sample size calculation. sample size is based on two-sample t test with one-sided type 1 error of 2.5%. Assuming a same mean of change in A1C for the treatment arm and control arm and a common standard deviation of 1% for both treatment groups, it showed that a total of 200 subjects will provide over 80% power to detect the non-inferiority with a margin of 0.4%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.05
Confidence Interval (1-Sided) 97.5%
0.15
Estimation Comments [Not Specified]
2.Primary Outcome
Title The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)
Hide Description An event is identified as: LGS feature in the correct setting; CGM values <= 65 mg/dL continuously with starting time between 10pm - 8am; No evidence of patient intervention during the first 20 minutes when CGM value was <= 65 mg/dL; The rate of change before reaching sensor glucose value of <= 65 mg/dL was <= 5 mg/dl/minutes; If the time between two successive events was less than 30 minutes, they will be combined as one event; An evaluable event is defined as any event with CGM value <= 65 mg/dL of greater than 20 minutes and the LGS feature is on the correct setting; Event AUC analysis was performed based on logarithm of AUC data.
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' Group B Without Low Glucose Suspend (LGS) Feature
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 121 126
Mean (Standard Deviation)
Unit of Measure: mg/dL x min
980  (1200.1) 1568  (1994.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A With Low Glucose Suspend (LGS) Feature Turned 'ON', Group B Without Low Glucose Suspend (LGS) Feature
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -588
Estimation Comments [Not Specified]
Time Frame Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Adverse Event Reporting Description Adverse events during run-in (training) period are available upon request
 
Arm/Group Title Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' Group B Without Low Glucose Suspend (LGS) Feature
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' Group B Without Low Glucose Suspend (LGS) Feature
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' Group B Without Low Glucose Suspend (LGS) Feature
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/121 (0.00%)      2/126 (1.59%)    
Infections and infestations     
Pneumonia * 1 [1]  0/121 (0.00%)  0 1/126 (0.79%)  1
Metabolism and nutrition disorders     
Hypoglycemia * 1 [1]  0/121 (0.00%)  0 1/126 (0.79%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
[1]
Not related to study device or study procedure
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' Group B Without Low Glucose Suspend (LGS) Feature
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/121 (32.23%)      41/126 (32.54%)    
Ear and labyrinth disorders     
Ear pain * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Eye disorders     
Conjunctivitis * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Gastrointestinal disorders     
Toothache * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Nausea * 1  2/121 (1.65%)  2 1/126 (0.79%)  1
Food poisoning * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Vomit * 1  1/121 (0.83%)  1 2/126 (1.59%)  2
Stomach Discomfort * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
General disorders     
Injection site haemorrhage * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Dental bridge failure * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Pyrexia * 1  3/121 (2.48%)  3 0/126 (0.00%)  0
Application site bleeding * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Infections and infestations     
Acute Sinusitis * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Bacterial Infection * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Bronchitis Acute * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Cellulitis * 1  1/121 (0.83%)  1 1/126 (0.79%)  1
Ear Infection * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Gastroenteritis * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Gastroenteritis Viral * 1  2/121 (1.65%)  2 1/126 (0.79%)  1
Infection * 1  0/121 (0.00%)  0 1/126 (0.79%)  2
Influenza * 1  1/121 (0.83%)  1 2/126 (1.59%)  2
Infusion Site Infection * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Kidney Infection * 1  0/121 (0.00%)  0 2/126 (1.59%)  2
Nasopharyngitis * 1  3/121 (2.48%)  3 7/126 (5.56%)  7
Otitis media * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Pharyngitis * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Respiratory Tract Infection * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Sinusitis * 1  2/121 (1.65%)  2 2/126 (1.59%)  2
Tonsillitis * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Tooth Abscess * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Upper Respiratory Track Infection * 1  3/121 (2.48%)  4 5/126 (3.97%)  5
Urinary Tract Infection * 1  1/121 (0.83%)  1 1/126 (0.79%)  1
Vaginal Mycosis * 1  2/121 (1.65%)  2 0/126 (0.00%)  0
Gingival infection * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Injury, poisoning and procedural complications     
Contusion * 1  1/121 (0.83%)  1 2/126 (1.59%)  2
Fibula fracture * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Skin laceration * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Foot fracture * 1  0/121 (0.00%)  0 2/126 (1.59%)  2
Meniscus lesion * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Tibia fracture * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycaemia * 1  4/121 (3.31%)  4 3/126 (2.38%)  3
Hypoglycemia * 1  0/121 (0.00%)  0 3/126 (2.38%)  3
Musculoskeletal and connective tissue disorders     
Neck pain * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Chest wall pain * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Osteoarthritis * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Exostosis * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Nervous system disorders     
Migraine * 1  2/121 (1.65%)  2 1/126 (0.79%)  1
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal Pain * 1  3/121 (2.48%)  3 1/126 (0.79%)  1
Sinus congestion * 1  3/121 (2.48%)  4 0/126 (0.00%)  0
Cough * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
Nasal congestion * 1  1/121 (0.83%)  1 2/126 (1.59%)  2
Skin and subcutaneous tissue disorders     
Ecchymosis * 1  1/121 (0.83%)  1 1/126 (0.79%)  2
Nail hypertrophy * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Dermatitis contact * 1  1/121 (0.83%)  1 1/126 (0.79%)  1
Skin irritation * 1  0/121 (0.00%)  0 2/126 (1.59%)  3
Rash * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Dermatitis * 1  1/121 (0.83%)  1 0/126 (0.00%)  0
Surgical and medical procedures     
Endodontic procedure * 1  0/121 (0.00%)  0 1/126 (0.79%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Thomas Troub
Organization: Medtronic
Phone: (818) 576-3142
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01497938     History of Changes
Other Study ID Numbers: CEP 237
First Submitted: December 18, 2011
First Posted: December 23, 2011
Results First Submitted: October 24, 2013
Results First Posted: March 17, 2014
Last Update Posted: March 17, 2014