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Type 1 Diabetes MellitusNCT01582139

Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker

A study testing Heart rate informed SSM+HMM in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site 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 Platform (AP Platform = Cell Phone + Closed Loop Control) 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 21 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Heart rate informed SSM+HMM
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
May 2012to Aug 2012
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 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥21 and <65 years old with clinical diagnosis of Type 1 Diabetes Mellitus for at least 1 year.
  • Criteria for documented hyperglycemia (at least 1 criterion must be met):
  • Fasting glucose ≥126 mg/dL - confirmed
  • Two-hour Oral Glucose Tolerance Test (OGTT) glucose ≥200 mg/dL - confirmed
  • HbA1c ≥6.5% documented - confirmed
  • Random glucose ≥200 mg/dL with symptoms
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  • No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes.
  • Criteria for requiring insulin at diagnosis (at least 1 criterion 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 require insulin eventually and used continually
  • Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes (LADA) in adults and did require insulin eventually and used continually.
  • Criteria for Type 1 Diabetes Mellitus (at least 1 criterion must be met)
  • Documented low or absent C-peptide level.
  • Documented presence of Islet Cell Cytoplasmic Autoantibodies (ICA) or Glutamic Acid Decarboxylase (GAD65) antibodies.
  • Use of an insulin pump to treat his/her diabetes for at least 6 months
  • Actively using a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate (CHO) ratio, insulin sensitivity factor (ISF), and target glucose
  • 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 during the study interventions involving continuous glucose monitor use.
  • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, have stability on the medication for at least 2 months prior to enrollment in the study.

Who cannot join

  • Clinical diagnosis of Type 2 Diabetes Mellitus
  • Diabetic ketoacidosis within the 6 months prior to enrollment
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
  • Pregnancy, breast feeding, or intention of becoming pregnant
  • Uncontrolled arterial hypertension (diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg)
  • Hematocrit <36% (females); <38% (males)
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  • Uncontrolled thyroid disease or thyroid replacement as determined by a thyroid-stimulating hormone (TSH) out of the UVa reference range.
  • Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase >2 times the upper limit of normal
  • Impaired renal function measured as creatinine >1.5 mg/dL
  • Conditions which may increase the risk of hypoglycemia such as known coronary artery disease (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages >50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation
  • Additional conditions which may inhibit the ability to perform exercise on a stationary bike (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 (CGM) (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 admissions.
  • 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
  • Current or recent alcohol or drug abuse by patient history
  • Medical conditions that would make operating a CGM, 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 microvascular (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, anti-depressant 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
  • Known 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 the continuous glucose monitor is in use.
  • Unwillingness to withhold dietary supplements two weeks prior to admission and for the duration of the study participation.
  • Subjects with basal rates less than 0.05.
  • Restrictions on use of other drugs or treatments
  • Pramlintide, liraglutide and exenatide will be held for the duration of the study intervention.
  • Oral steroids are excluded
  • Anticoagulant therapy other than aspirin is excluded
  • Acetaminophen will not be allowed while the continuous glucose monitor is in use
  • Dietary supplements will be withheld two weeks prior to admission and for the duration of study participation
  • Beta blockers, reserpine, guanethidine, methyldopa, clonidine, cimetidine, digitalis, calcium channel blockers, amiodarone, antiarrythmic drugs, and lithium are excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

The purpose of this study is to see if the Artificial Pancreas Platform (AP Platform = Cell Phone + Closed Loop Control) 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 information about heart rate can help the AP Platform reduce hypoglycemia related to exercise.

Read the detailed description

The combination of the Control to Range system and the cell phone is called the "Artificial Pancreas (AP) Platform". The purpose of this study is to see if this investigational technology can help control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy can be successfully used and supervised in a hospital setting. This study is also being done to see if giving information about heart rate to the Closed-to-Range System can reduce hypoglycemia as it relates to exercise. Subjects will exercise on an exercise bike in the clinical research unit. During one exercise testing session, the Closed-to-Range System will receive information about your heart rate (Experimental Condition). During the other exercise testing session, the Control to Range System will not receive information about your heart rate (Control Condition). This part of the study is being done to see whether heart rate information helps the Closed-to-Range System reduce the occurrences of exercise-related hypoglycemia.

The Closed-to-Range system has two parts (modules) that can work together or separately.

  1. The Safety Supervision Module (SSM) helps to prevent low blood sugars. It can reduce the amount of basal insulin that the pump is delivering and alert you if carbohydrates are needed to help prevent a low blood sugar. This module will be active at all times during the operation of the Closed-to-Range System.
  2. The Hyperglycemia Mitigation Module (HMM) helps to prevent high blood sugars. It can instruct the insulin pump to deliver small boluses to help prevent high blood sugar. It can also help warn you of a possible pump problem if the blood sugar level is not responding to the insulin as it should.

The Closed-to-Range System works with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL) during the day and help avoid hypoglycemia during the night.

Being tested
Heart rate informed SSM+HMM
Keywords
Artificial Pancreas Project, AP Platform, Insulin Pump, Continuous Glucose Monitor, Closed-Loop Control, Control-to-Range
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 informed SSM+HMMDevice

    The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.

Study groups in NCT01582139
Study groupRoleWhat they receive
Experimental Condition: (Heart-Rate Informed SSM+HMM)ExperimentalAn experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate
Receives: Device: Heart rate informed SSM+HMM
Control Condition (SSM+HMM)No interventionA control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.

What is being measured

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

  1. Hypoglycemic Events

    Plasma glucose based number of hypoglycemic events, defined as consecutive plasma readings below 70mg/dl to measure the capacity of the system to protect patients against the risk of hypoglycemia. Two events separated by only one Yellow Springs Instrument (YSI) value over 70 are considered to form a single event.

    Measured: 26 hours (x2 admissions)

Secondary outcomes (3)

  1. Low Blood Glucose Index

    A measure of the risk of hypoglycemia. It quantifies the frequency and the extent of low BG readings.

    A LBGI < 2.5 is associated with a low-risk of hypoglycemia, LBGI 2.5-5 is associated with a moderate risk of hypoglycemia, and LBGI > 5 is associated with a high-risk of hypoglycemia.

    Measured: 26 hours (x2 admissions)

  2. Average Glucose Drop

    Average glucose drops at specific time points after the onset of exercise; defined as the difference between plasma glucose at onset of exercise and the glucose values reached at 40 and 60 min post onset of exercise.

    Measured: 26 hours (2x admissions)

  3. Time in Range

    Percent time spent within target (70-180 mg/dL) range.

    Measured: 26 hours (x2 admissions)

Timeline

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

  1. First posted20 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2012
  4. Study completionAug 2012

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01582139
Sponsor's protocol ID
15970
Other IDs
5R21DK085641
Status last verified
Jul 2014
First submitted
18 Apr 2012
Last updated
15 Aug 2014
Data monitoring committee
No

Publications

  • Breton MD, Brown SA, Karvetski CH, Kollar L, Topchyan KA, Anderson SM, Kovatchev BP. Adding heart rate signal to a control-to-range artificial pancreas system improves the protection against hypoglycemia during exercise in type 1 diabetes. Diabetes Technol Ther. 2014 Aug;16(8):506-11. doi: 10.1089/dia.2013.0333. Epub 2014 Apr 4.

    PubMed 24702135

Questions about this trial

What is this clinical trial studying?

A study testing Heart rate informed SSM+HMM in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site 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 21 inclusion and 38 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 15 Aug 2014). 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?

Hypoglycemic Events (time frame: 26 hours (x2 admissions)). 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 NCT01582139, 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 15 Aug 2014.

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