N/A
Completed N=16
Medtronic Minimed Overnight Closed-Loop System
Type 1 diabetes mellitus · Autoimmune Diabetes · Juvenile-Onset Diabetes · Diabetes, Mellitus, Type 1
Source: ClinicalTrials.gov NCT01881009 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Target Sensor Glucose 70-150 mg/dl — 66.4; 50.6 percentage of time — p=0.004
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Sensor Glucose 70-150 mg/dl |
63 | — |
| SECONDARY Target Sensor Glucose 70-180 mg/dl |
79.9; 60.0 | 0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01881009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.