Trial Outcomes & Findings for Medtronic MiniMed Implantable Insulin Pump (NCT NCT00298740)
NCT ID: NCT00298740
Last Updated: 2017-09-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
End of study, approximately 5 years
Results posted on
2017-09-12
Participant Flow
Participant milestones
| Measure |
Aventis U-400 Insulin
Aventis U-400 Insulin
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Aventis U-400 Insulin
Aventis U-400 Insulin
|
|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Medtronic MiniMed Implantable Insulin Pump
Baseline characteristics by cohort
| Measure |
Aventis U-400 Insulin
n=12 Participants
Aventis U-400 Insulin
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of study, approximately 5 yearsPopulation: It is unclear whether data was collected. No data is available and exhaustive searching has yielded no person with historical knowledge of this study or access to any data. Information obtained in other sections was from Regulatory records retrieved from long-term storage. This study closed in 2009 and the Principal Investigator is deceased.
Outcome measures
Outcome data not reported
Adverse Events
Aventis U-400 Insulin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Aventis U-400 Insulin
n=12 participants at risk
Aventis U-400 Insulin
|
|---|---|
|
Cardiac disorders
Death
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
Aventis U-400 Insulin
n=12 participants at risk
Aventis U-400 Insulin
|
|---|---|
|
Gastrointestinal disorders
Rectal hemorrage
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
25.0%
3/12 • Number of events 3
|
|
Endocrine disorders
Hypoglycemia
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Left lower quadrant pain
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right groin pain
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Poison ivy
|
8.3%
1/12 • Number of events 1
|
|
Surgical and medical procedures
Cataract surgery
|
8.3%
1/12 • Number of events 1
|
|
Product Issues
Pump stopped
|
8.3%
1/12 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
8.3%
1/12 • Number of events 1
|
|
Surgical and medical procedures
Gall bladder surgery
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Adhesive capsulitis
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Swollen abdomen
|
8.3%
1/12 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Lyme disease
|
8.3%
1/12 • Number of events 1
|
|
Product Issues
Pump explant
|
50.0%
6/12 • Number of events 6
|
|
Immune system disorders
High insulin antibodies
|
8.3%
1/12 • Number of events 1
|
|
Endocrine disorders
Diabetic ketoacidosis
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
External Otitis
|
8.3%
1/12 • Number of events 1
|
|
Product Issues
Changed site location
|
8.3%
1/12 • Number of events 1
|
|
Surgical and medical procedures
Right ankle surgery
|
8.3%
1/12 • Number of events 1
|
|
Endocrine disorders
Hyperglycemia
|
25.0%
3/12 • Number of events 3
|
|
Infections and infestations
Pump site infection
|
8.3%
1/12 • Number of events 1
|
Additional Information
Johns Hopkins ClinicalTrials.gov Program
Johns Hopkins University
Phone: 410-550-6484
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place