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Type 1 Diabetes MellitusNCT01945060

Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator

A study of Type 1 Diabetes Mellitus, run by Marc Breton at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Type 1 Diabetes Mellitus
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
2 sitesUnited States
Study dates
Sep 2013to Apr 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
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  • 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
  • Actively use a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate (CHO) ratio, insulin sensitivity factor (ISF), and target glucose
  • Current HbA1c between 5.0% and 10.5% as measured with DCA2000 or equivalent device
  • Not currently known to be pregnant, breast feeding, or intending to become pregnant (females)
  • Demonstration of proper mental status and cognition for the study
  • Willingness to avoid consumption of acetaminophen-containing products while wearing the continuous glucose monitor sensor.

Who cannot join

  • 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)
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  • 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)
  • Any skin condition that prevents sensor or pump placement on the abdomen or arm (e.g. bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
  • Known micro vascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment
  • Active gastroparesis requiring current medical therapy
  • If on antihypertensive, thyroid, or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
  • Known bleeding diathesis or dyscrasia
  • Allergy to medical adhesives, components of the insulin pump insertion set or continuous glucose monitor sensor
  • Anticoagulant therapy other than aspirin
  • Oral steroids
  • Active enrollment in another clinical trial
  • Unwillingness to avoid acetaminophen while wearing the continuous glucose monitor sensor.
  • Unwillingness to withhold dietary supplements two weeks prior to and during admission
  • Unwillingness to use an approved form of birth control during this study by a sexually active female participant.
  • Subject develops a febrile illness within 24 hours of inpatient admission.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Virginia Center for Diabetes Technology

    Charlottesville, Virginia, 22903

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298-0140

Other trials in United States

About this study

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.

Read the detailed description

The artificial pancreas (AP), known as Closed-Loop Control of blood glucose in diabetes, is a system combining a continuous glucose monitor (glucose sensor), a control algorithm (complex mathematical formulas), and an insulin pump. The algorithms are intended to maintain your blood glucose level within a certain range. This is called Control-to-Range. The algorithms are intended to maintain your blood glucose level within a certain range. The algorithms run on a portable AP platform on an Android smart phone, called the Diabetes Assistant (DiAs) Medical Platform.

In this study, researchers hypothesize that the heart rate informed Control To Range (hrCTR) will limit the risk for hypo and hyperglycemia during and immediately after exercise in adolescents 12 - 17 years of age and assess if the hrCTR will improve additional measures of overall short term glycemic control in this population.

This trial will be performed at both Virginia Commonwealth University and the University of Virginia. IRB approvals have been obtained at both institutions.

Being tested
heart rate Control to Range System (hrCTR) using DiAs Platform, DiAs Control-to-Range System not informed for heart rate
Keywords
Artificial Pancreas Project, Diabetes Assistant (DiAs) Medical Platform System, Artificial Pancreas Platform, Insulin Pump, Continuous Glucose Monitor, Closed-Loop Control, heart rate Control to Range System (hrCTR)
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • heart rate Control to Range System (hrCTR) using DiAs PlatformDevice

    Diabetes Assistant (DiAs) Medical Platform System

    • A smart-phone medical platform (DiAs);
    • Continuous Glucose Monitor;
    • Insulin pump;
    • Bluetooth connection;
    • Remote Monitoring Server.

  • DiAs Control-to-Range System not informed for heart rateOther

    Not informing system of heart rate during exercise.

Study groups in NCT01945060
Study groupRoleWhat they receive
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.
Receives: Device: heart rate Control to Range System (hrCTR) using DiAs Platform
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.
Receives: Device: heart rate Control to Range System (hrCTR) using DiAs Platform; Other: DiAs Control-to-Range System not informed for heart rate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01945060
Sponsor's protocol ID
HM15215 & 17256
Other IDs
17-2013-498
Status last verified
Jun 2023
First submitted
10 Sep 2013
Last updated
21 Aug 2023
Data monitoring committee
No

Publications

  • 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.

    PubMed 27734563

Questions about this trial

What is this clinical trial studying?

A study of Type 1 Diabetes Mellitus, run by Marc Breton at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low Blood Glucose Index (LBGI) (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01945060, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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Clinical Trial NCT01945060 | AzTrials