Medtronic Minimed Overnight Closed-Loop System (NCT01881009) | Clinical Trial Compass
CompletedNot Applicable
Medtronic Minimed Overnight Closed-Loop System
United States37 participantsStarted 2013-06
Plain-language summary
To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study. Once the safety of the device has been validated we will move the study to an outpatient diabetes camp setting. The camp setting will allow us to obtain pilot efficacy and safety data in a "real-life" environment.
We plan to compare the subject control nights to the subject nights on the OCL system to assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on previous research, we anticipate that the use of the OCL system will contribute to a greater percentage of sensor glucose readings in the target range.
Who can participate
Age range
10 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
To be eligible for the study, a subject must meet the following criteria:
* Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and a Medtronic insulin infusion pump for at least 3 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
* Age 10.0 - 35 years
Exclusion Criteria:
The presence of any of the following is an exclusion for the study:
* Diabetic ketoacidosis in the past month
* Hypoglycemic seizure or loss of consciousness in the past 3 months
* History of seizure disorder (except for hypoglycemic seizure)
* History of any heart disease including coronary artery disease, heart failure, or arrhythmias
* Cystic fibrosis
* Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
* History of ongoing renal disease (other than microalbuminuria).
* Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as:
* Inpatient psychiatric treatment in the past 6 months
* Uncontrolled adrenal disorder
* Abuse of alcohol
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.