NCT02147860

Brief Summary

The overall aim of this proposed research is to determine the safety, feasibility and efficacy of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting. This will be addressed in two parts: 1) An in residence, outpatient study to determine safety and feasibility of the DiAs during 72 continuous hours of day and night glucose control; and 2) Camp studies planned for the summer of 2014 with randomization to either full closed-loop or sensor-augmented pump therapy over the duration of 6-7 day diabetes camps.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 19, 2016

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

May 21, 2014

Last Update Submit

July 15, 2016

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1Artificial Pancreas Project (APP)Diabetes Assistant (DiAs)Closed-Loop Control (CLC)Continuous Glucose Monitor (CGM)Insulin Pump

Outcome Measures

Primary Outcomes (1)

  • DiAs time within target

    Determine the efficacy of glucose control, as determined by the percentage of sensor glucose readings in the target range

    7 days/6 nights

Study Arms (2)

Sensor Augmented Pump Therapy

PLACEBO COMPARATOR

Each camp participant will be randomized to full day and night CLC or sensor augmented pump therapy for up to 7 days/6 nights. The subject will wear a continuous glucose monitoring system (CGM) to measure sensor glucose and a physiological monitor to measure heart rate and 3-axis accelerometer for 24-72 hours.

Other: Sensor Augmented Pump Therapy

Diabetes Assistant (DiAs) with USS Virginia

EXPERIMENTAL

With the use of the UVA Artificial Pancreas (DiAs), the study will assess safety and feasibility and are not powered for statistical significance. These studies are intended to train staff on system function and obtain data regarding safe and feasible system use. Camp participants will be randomized to either closed-loop control using the DiAs or sensor-augmented pump therapy only. These studies would generate up to 120 days of closed-loop data and 120 comparable days of open-loop data.

Device: Diabetes Assistant (DiAs) with USS Virginia

Interventions

Diabetes Assistant (DiAs) with USS VirginiaDEVICE

DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and help avoid hypoglycemia during the night.

Also known as: Closed-Loop system
Diabetes Assistant (DiAs) with USS Virginia
Sensor Augmented Pump TherapyOTHER

Subjects randomized to this placebo group will wear a continuous glucose monitoring system (CGM) to measure sensor glucose and a physiological monitor to measure heart rate and 3-axis accelerometer for 24-72 hours.

Also known as: SAP
Sensor Augmented Pump Therapy

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of type 1 diabetes
  • The diagnosis of type 1 diabetes is based on the investigator's judgment
  • C peptide levels and antibody determinations are not required
  • Daily insulin therapy for ≥ 12 months
  • Insulin pump therapy for ≥ 3 months
  • Age 10.0 - 35.0 years
  • Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
  • Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
  • Female subjects who are sexually active must be on acceptable method of contraception (e.g. oral contraceptive pill, diaphragm, IUD)

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 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).
  • Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
  • Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
  • Pregnancy - verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned.
  • Sexually active females who do not practice acceptable contraceptive methods to prevent pregnancy.
  • Presence of a febrile illness within 24 hours of admission or acetaminophen use while wearing the CGM. The subject may be rescheduled for Research House/hotel admission if these criteria are not met. The camp study subject will not participate in the trial if these conditions are met.
  • 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 insufficiency
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 93405, United States

Location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

  • Ly TT, Buckingham BA, DeSalvo DJ, Shanmugham S, Satin-Smith M, DeBoer MD, Oliveri MC, Schertz E, Breton MD, Chernavvsky DR. Day-and-Night Closed-Loop Control Using the Unified Safety System in Adolescents With Type 1 Diabetes at Camp. Diabetes Care. 2016 Aug;39(8):e106-7. doi: 10.2337/dc16-0817. Epub 2016 Jun 6. No abstract available.

    PMID: 27271182RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bruce Buckingham, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 28, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 19, 2016

Record last verified: 2015-11

Data Sharing

IPD Sharing
Will share

Paper Published in Diabetes Care

Locations

US(2)