Medtronic Minimed Overnight Closed-Loop System

NCT01881009 | Completed Results DMC

• 1 other identifier: G130115 IRB 27462
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus; Autoimmune Diabetes; Juvenile-Onset Diabetes; Diabetes, Mellitus, Type 1

Keywords

Diabetes; Insulin; Closed loop; Nocturnal glucose control

Outcome Measures

Primary Outcomes (2)

• Target Sensor Glucose 70-150 mg/dl

  Compared to control nights, the percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.

  Approximately 12 hours

• Target Sensor Glucose 70-150 mg/dl

  Percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.

  Approximately 12 hours

Secondary Outcomes (1)

• Target Sensor Glucose 70-180 mg/dl

  Approximately 12 hours

Study Arms (2)

Inpatient overnight

EXPERIMENTAL

Participants in this group will have an overnight evaluation to test safety of the closed-loop system therapy device.

Device: Hybrid Closed-loop System

Summer Camp Session

EXPERIMENTAL

Participants in this group will receive either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study.

Device: Hybrid Closed-loop System; Device: Sensor-augmented pump

Interventions

Hybrid Closed-loop System DEVICE

Medtronic Revel insulin pump, Enlite 3 sensor, Minimed transmitter, PID-IFB (proportional-integral-derivative based with insulin feedback) algorithm on an Android platform with remote monitoring.

Inpatient overnight; Summer Camp Session

Sensor-augmented pump DEVICE

Medtronic Revel insulin pump, Enlite 3 sensor, Minimed transmitter.

Summer Camp Session

Eligibility Criteria

• Age: 10 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bruce A. Buckingham: lead

Study Sites (1)

Stanford University

Stanford, California, 94305-5208, United States

Location

Related Publications (1)

• Ly TT, Keenan DB, Roy A, Han J, Grosman B, Cantwell M, Kurtz N, von Eyben R, Clinton P, Wilson DM, Buckingham BA. Automated Overnight Closed-Loop Control Using a Proportional-Integral-Derivative Algorithm with Insulin Feedback in Children and Adolescents with Type 1 Diabetes at Diabetes Camp. Diabetes Technol Ther. 2016 Jun;18(6):377-84. doi: 10.1089/dia.2015.0431. Epub 2016 May 16.

  PMID: 27183197 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Bruce Buckingham, M.D.
• Organization: Stanford University

buckingham@stanford.edu

408-356-0911

Study Officials

• Bruce Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor, Pediatrics

Study Record Dates

• First Submitted: June 16, 2013
• First Posted: June 19, 2013
• Study Start: June 1, 2013
• Primary Completion: August 3, 2013
• Study Completion: August 3, 2013
• Last Updated: November 14, 2019
• Results First Posted: November 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)