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| ID | Type | Description | Link |
|---|---|---|---|
| RR00052 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Medtronic | INDUSTRY |
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This research is being done to find out whether subjects previously treated with the implantable insulin pump (IIP) therapy, and now taking insulin by injection, will benefit from re-implantation of IIP. The investigators will see if IIP causes more stable control of blood sugar, with fewer highs and lows. People with type 1 diabetes previously implanted with the MiniMed Implantable Pump (MIP) model 2000 at Johns Hopkins may join this study.
If the participant joins the study and chooses to have a new pump implanted, the study is expected to last 12-15 months for each participant, and each participant will continue to be followed, with 3-monthly refills and research visits for as long as the pump lasts, until the participant chooses to withdraw, until the FDA approves the pump for regular care, or until the company stops supporting the pump. During the first 12-15 months of the study, there will be an estimated 13 clinic visits and one hospital stay for 2-3 days. The data collection visits will take about 30 minutes, and a continuous glucose monitor will be started. The participants will have a brief visit 3-4 days later to drop off the monitor. After this phase of the research, the participants will still be cared for with the implanted pump, having visits for refills and tests every 3 months. This long-term follow up will last until the participants choose to withdraw, the pump malfunctions, the FDA approves the pump for regular care, or the company no longer supports the pump. If the participants are no longer taking part in the study, the investigators will have the pump removed from their body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aventis U-400 Insulin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aventis U-400 Insulin | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Control as Assessed by Mean Glucose Levels | End of study, approximately 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Saudek, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19885248 | Background | Witkowski CJ, Saudek C. The implantable peritoneal pump--a patient's perspective. J Diabetes Sci Technol. 2008 Jul;2(4):703-6. doi: 10.1177/193229680800200423. | |
| 16800761 | Background | Moore KB, Saudek CD, Greene A, Dackiw A. Implantable insulin pump therapy: an unusual presentation of a catheter-related complication. Diabetes Technol Ther. 2006 Jun;8(3):397-401. doi: 10.1089/dia.2006.8.397. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aventis U-400 Insulin | Aventis U-400 Insulin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aventis U-400 Insulin | Aventis U-400 Insulin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glucose Control as Assessed by Mean Glucose Levels | 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. | Posted | End of study, approximately 5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aventis U-400 Insulin | Aventis U-400 Insulin | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Heart Attack |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal hemorrage | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johns Hopkins ClinicalTrials.gov Program | Johns Hopkins University | 410-550-6484 | registerclinicaltrials@jhmi.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 12 |
| 1 |
| 12 |
| 12 |
| 12 |
| Fracture | Musculoskeletal and connective tissue disorders |
|
| Hypoglycemia | Endocrine disorders |
|
| Left lower quadrant pain | Gastrointestinal disorders |
|
| Right groin pain | Musculoskeletal and connective tissue disorders |
|
| Right shoulder pain | Musculoskeletal and connective tissue disorders |
|
| Poison ivy | Skin and subcutaneous tissue disorders |
|
| Cataract surgery | Surgical and medical procedures |
|
| Pump stopped | Product Issues |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Gall bladder surgery | Surgical and medical procedures |
|
| Adhesive capsulitis | Musculoskeletal and connective tissue disorders |
|
| Swollen abdomen | Gastrointestinal disorders |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Lyme disease | Infections and infestations |
|
| Pump explant | Product Issues |
|
| High insulin antibodies | Immune system disorders |
|
| Diabetic ketoacidosis | Endocrine disorders |
|
| External Otitis | Eye disorders |
|
| Changed site location | Product Issues |
|
| Right ankle surgery | Surgical and medical procedures |
|
| Hyperglycemia | Endocrine disorders |
|
| Pump site infection | Infections and infestations |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |