Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator
2 other identifiers
interventional
22
1 country
2
Brief Summary
The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a hospital setting. Investigators will also be studying to see if the heart rate informed Control To Range (hrCTR) can improve the performance of the system during and immediately after exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
2 active sites
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
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 10, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
August 21, 2023
CompletedAugust 21, 2023
June 1, 2023
1.6 years
September 10, 2013
August 1, 2022
August 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Low Blood Glucose Index (LBGI)
The Low Blood Glucose Index, which quantifies the risk for hypoglycemia, and the hypoglycemic count (number sequences of blood glucose less than 70 mg/dL). The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI is measured on a scale from 0 to 100 and a higher score indicates a worse outcome.
24 hours
Study Arms (2)
heart rate Control to Range System (hrCTR) THEN No heart rate Control to Range System (hrCTR)
EXPERIMENTALThe Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate during exercise. The study team member will activate and deactivate a heart rate button when the subject's heart rate exceeds and then returns below 140 beats per minute.
No heart rate Control to Range System (hrCTR) THEN heart rate Control to Range System (hrCTR)
PLACEBO COMPARATORUsing the DiAs Platform, the Control-to-Range system is not notified of the heart rate during exercise. Heart rate not of interest in this arm.
Interventions
Diabetes Assistant (DiAs) Medical Platform System * A smart-phone medical platform (DiAs); * Continuous Glucose Monitor; * Insulin pump; * Bluetooth connection; * Remote Monitoring Server.
Not informing system of heart rate during exercise.
Eligibility Criteria
You may qualify if:
- Criteria for documented hyperglycemia (at least 1 must be met):
- Fasting glucose ≥ 126 mg/dL - confirmed
- Two-hour Oral Glucose Tolerance Test (OGTT) glucose ≥ 200 mg/dL - confirmed
- Hemoglobin A1c (HbA1c) ≥ 6.5% documented - confirmed
- Random glucose ≥ 200 mg/dL with symptoms
- No data are available from the time of diagnosis but the participant has a convincing history of medical care and biochemical parameters consistent with T1DM
- Criteria for requiring insulin at diagnosis (1 must be met):
- Participant required insulin at diagnosis and continually thereafter
- Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did eventually require insulin that has been used continually
- Criteria for Type 1 Diabetes Mellitus (T1DM) (at least 1 must be met):
- Documented low or absent C-peptide level.
- Documented presence of islet cell autoantibodies (ICA) or glutamic acid decarboxylase (GAD65) autoantibodies.
- No data are available from the time of diagnosis but the participant has a convincing history of medical care and biochemical parameters consistent with T1DM
- In addition, all subjects will meet the following additional criteria:
- Use an insulin pump (CSII) to treat his/her diabetes for at least 6 months
- +5 more criteria
You may not qualify if:
- Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM)
- Diabetic ketoacidosis within 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
- Pregnancy, breast feeding, or intention to become pregnant
- Subjects weighing less than 40 kg
- Hematocrit \<36% (females); \<38% (males)
- Conditions which may increase the risk of hypoglycemia such as known history of cerebrovascular event, history of arrhythmias, seizure disorder, syncope, adrenal insufficiency, or neurologic disease
- Additional conditions which may inhibit the ability to perform exercise (e.g. injury to or immobility of limbs, neuromuscular disease, exercise-induced asthma requiring inhaler use within the last 12 months or clinically impaired pulmonary function)
- Use of a medication that significantly lowers heart rate (beta blockers, reserpine, guanethidine, methyldopa, clonidine, cimetidine, digitalis, calcium channel blockers, amiodarone, antiarrythmic drugs, or lithium)
- History of a systemic or deep tissue infection with methicillin-resistant staph aureus or Candida albicans
- Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the continuous glucose monitor (implantable cardioverter defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
- Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admission.
- Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment, uncontrolled anxiety or panic disorder)
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Medical conditions that would make operating a continuous glucose monitor, cell phone or insulin pump difficult (e.g. blindness, severe arthritis, immobility)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marc Bretonlead
- Virginia Commonwealth Universitycollaborator
- DexCom, Inc.collaborator
- Tandem Diabetes Care, Inc.collaborator
Study Sites (2)
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0140, United States
Related Publications (1)
DeBoer MD, Chernavvsky DR, Topchyan K, Kovatchev BP, Francis GL, Breton MD. Heart rate informed artificial pancreas system enhances glycemic control during exercise in adolescents with T1D. Pediatr Diabetes. 2017 Nov;18(7):540-546. doi: 10.1111/pedi.12454. Epub 2016 Oct 13.
PMID: 27734563RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marc D Breton
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Francis, MD, PhD
Virginia Commonwealth University
- PRINCIPAL INVESTIGATOR
Marc Breton, PhD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Co-Principal Investigator
Study Record Dates
First Submitted
September 10, 2013
First Posted
September 18, 2013
Study Start
September 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 21, 2023
Results First Posted
August 21, 2023
Record last verified: 2023-06