Type 1 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAventis U-400 Insulin
Sponsors
National Institutes of Health (NIH)
Medtronic
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* People with type 1 diabetes previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins may join this study.
Exclusion criteria
* Anyone not previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose Control as Assessed by Mean Glucose Levels | End of study, approximately 5 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aventis U-400 Insulin Aventis U-400 Insulin | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 6 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Aventis U-400 Insulin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 12 |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Glucose Control as Assessed by Mean Glucose Levels
Time frame: End of study, approximately 5 years
Population: 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.