NCT01973413

Brief Summary

The primary goal is to test the function of the Diabetes Assistant (DiAs) enhanced control-to-range (CTR) controller in a closely monitored diabetes camp setting. The camp setting will allow us to obtain pilot efficacy data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 15, 2014

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

October 24, 2013

Results QC Date

June 27, 2014

Last Update Submit

April 3, 2015

Conditions

Diabetes Mellitus, Type 1

Keywords

Artificial Pancreas ProjectDiabetes Mellitus, Type 1Insulin pump therapyContinuous Glucose Monitors (CGM)Juvenile-Onset DiabetesAutoimmune DiabetesClosed-to-RangeDiabetes Assistant (DiAs)

Outcome Measures

Primary Outcomes (1)

  • Percent Time Near Normoglycemia

    Percent of time in a glucose target range of 70-150 mg/dl during camp study. Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were \~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error \>20%, or pump failure resulting in a \>60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, \<20% with a minimum of 5 hours were included in the control group.

    6 nights

Secondary Outcomes (2)

  • Overnight Glucose

    6 nights

  • Glycemic Events

    6 nights

Study Arms (2)

Closed-Loop Control with DiAs System

EXPERIMENTAL

Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.

Device: Diabetes Assistant (DiAs)Device: Tandem t:slim Insulin PumpDevice: Dexcom G4 Platinum sensor

Control Group, Sensor-Augmented Pump Therapy

PLACEBO COMPARATOR

Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.

Device: Tandem t:slim Insulin PumpDevice: Dexcom G4 Platinum sensor

Interventions

Diabetes Assistant (DiAs)DEVICE

The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range.

Closed-Loop Control with DiAs System
Tandem t:slim Insulin PumpDEVICE

FDA, market-approved insulin pump.

Closed-Loop Control with DiAs SystemControl Group, Sensor-Augmented Pump Therapy
Dexcom G4 Platinum sensorDEVICE

FDA, market-approved continuous glucose monitor (CGM)

Closed-Loop Control with DiAs SystemControl Group, 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 and using daily insulin therapy for at least one year and a Medtronic, Animas or Tandem insulin infusion pump for at least 3 months
  • The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide levels and antibody determinations are not required.
  • Age 10.0 - 35 years
  • Willingness to use a Sure-T or Contact Detach infusion set while at camp

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)
  • Using an OmniPod insulin infusion pump
  • 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).
  • Insulin pump users who supplement with injected intermediate or long acting insulin.
  • Subjects who take other anti-diabetic medications other than insulin..
  • 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 (verbal denial of pregnancy obtained with telephone informed consent, pregnancy test performed at camp before study devices are assigned).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Los Gatos, California, 95032, United States

Location

Related Publications (1)

  • Ly TT, Breton MD, Keith-Hynes P, De Salvo D, Clinton P, Benassi K, Mize B, Chernavvsky D, Place J, Wilson DM, Kovatchev BP, Buckingham BA. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Care. 2014 Aug;37(8):2310-6. doi: 10.2337/dc14-0147. Epub 2014 May 30.

    PMID: 24879841RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Marc Breton, PhD
Organization
Univeristy of VIrginia
mb6nt@virginia.edu
434-982-6484

Study Officials

  • Bruce Buckingham, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Marc Breton, PhD

    University of Virginia Center for Diabetes Technology

    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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

October 24, 2013

First Posted

October 31, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 24, 2015

Results First Posted

August 15, 2014

Record last verified: 2015-04

Locations

US(1)