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Full Day and Night Closed-Loop With DiAs Platform

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diabetes Assistant (DiAs) with USS Virginia

Sensor Augmented Pump Therapy

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Artificial Pancreas Project (APP), Diabetes Assistant (DiAs), Closed-Loop Control (CLC), Continuous Glucose Monitor (CGM), Insulin Pump

Eligibility Criteria

10 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be eligible for the study, a subject must meet the following criteria:

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)

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 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
- Alcohol abuse

Sites / Locations

Stanford University
University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sensor Augmented Pump Therapy

Diabetes Assistant (DiAs) with USS Virginia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

DiAs time within target

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02147860

First Posted

May 21, 2014

Last Updated

July 15, 2016

Sponsor

University of Virginia

Collaborators

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT02147860

Brief Title

Full Day and Night Closed-Loop With DiAs Platform

Official Title

Full Day and Night Closed-Loop With DiAs Platform

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study is an early feasibility study that will test the efficacy of DiAs - a smart-phone-based system compared to sensor augmented therapy in an outpatient setting. Twelve study subjects with type 1 diabetes, six each at UVa and Stanford University, who have experience with insulin pump use at two clinical sites will be recruited. The first six subjects recruited will be aged 15-18 years and this will follow with recruitment of six subjects aged 10-14 years. This study is designed to mimic the protocol at camp and will include a period of light exercise after breakfast and moderate intensity physical activity after lunch, with group activities such as soccer and volleyball. The duration of the Outpatient in Residence Study will be 72 hours. The data will be reviewed by the Data Safety Monitoring Board (DSMB) before proceeding to camp studies. The camp study will recruit 48 subjects, with type 1 diabetes who have experience with insulin pump therapy. Initial studies will be conducted at a camp with older participants aged 15-35 years, with at least 5 of the campers between 15-18 years old. These studies will be reviewed by the DSMB and, if safe, we will recruit additional children aged 10-14 years of age. The duration of the Diabetes Camp Studies will be up to 7 days/6 nights.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sensor Augmented Pump Therapy

Arm Type

Placebo Comparator

Arm Description

Arm Title

Diabetes Assistant (DiAs) with USS Virginia

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Diabetes Assistant (DiAs) with USS Virginia

Other Intervention Name(s)

Closed-Loop system

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sensor Augmented Pump Therapy

Other Intervention Name(s)

SAP

Intervention Description

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.

Primary Outcome Measure Information:

Title

DiAs time within target

Description

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

Time Frame

7 days/6 nights

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: To be eligible for the study, a subject must meet the following criteria: 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) 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 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 Alcohol abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Buckingham, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

93405

Country

United States

Facility Name

University of Virginia Center for Diabetes Technology

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Paper Published in Diabetes Care

Citations:

PubMed Identifier

27271182

Citation

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.

Results Reference

result

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/?term=Chernavvsky+D

Description

Pubmed

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Full Day and Night Closed-Loop With DiAs Platform

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