N/A
Completed N=8
Hybrid Closed-Loop Hotel Studies With Medtronic PID Controller
Source: ClinicalTrials.gov NCT02280863 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness — 0; 0; 1 Participants
Summary
The primary objective of this study is to evaluate the safety and efficacy of the Medtronic hybrid closed-loop (HCL) system utilizing the proportional-integral-derivative algorithm with insulin feedback (PID-IFB) optimized to function in a hybrid mode with closed-loop control operating during the day and night.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness |
0; 0; 1 | — |
| SECONDARY Mean Glucose Values |
151; 144; 171; 156; 152; 153 | — |
| SECONDARY Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts |
148; 164; 127; 151 | — |
| SECONDARY Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort |
181; 132 | — |
| SECONDARY Percentage of Time Within Glucose Range of 70-180 mg/dL |
71.9; 67.7; 55.2; 71.0; 71.8; 69.8 | — |
| SECONDARY Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL |
4.7; 13.0; 11.7; 1.4; 7.6; 13.5 | — |
| SECONDARY Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts |
2.7; 7.6; 1.4; 2.0; 3.5; 8.2 | — |
| SECONDARY Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort |
2.7; 2.5; 2.5; 0.7 | — |
| SECONDARY Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface |
0.0; 0.7 | — |
| SECONDARY Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort |
3.0; 8.9; 3.1; 6.7 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of type 1 diabetes (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
- Daily insulin therapy for at least one year
- Age between 14.0 to 40.0 years of age. The first 9 subjects (between all 3 centers) will be over 18 years old.
- Subject has performed an average of at least 3 meter glucose readings per day in the preceding 2 weeks
- Subject has used a downloadable insulin pump for at least 3 months
- Subject comprehends written English
- Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD
- Female patients must have a negative urine pregnancy test
- Informed Consent Form signed by the subject and/or parent and assent signed by the subject if 140 mmHg on screening visit
- Diastolic blood pressure > 90 mmHg on screening visit
- Subject has active Graves' disease
- Subjects with inadequately treated thyroid disease or celiac disease
- Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- Either the subject or the subject's primary caregiver has received inpatient psychiatric treatment in the past 6 months
- Subject has a history of diagnosed medical eating disorder
- Subject has a history of known illicit drug abuse
- Subject has a history of known prescription drug abuse
- Subject has a history of current alcohol abuse
- Subject has a history of visual impairment which would not allow subject to participate
- Subject has an active skin condition that would affect sensor placement
- Subject has adhesive allergies
- Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)
- Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Subject is currently on beta blocker medication
- Subject is currently participating in another investigational study (drug or device)
- Subject is deemed by the investigator to be unwilling or unable to follow the protocol
Data sourced from ClinicalTrials.gov (NCT02280863). 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.