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

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01582139

Run by

University of Virginia

People needed

12

Starts

2012-05-01

Expected to finish

2012-08-01

Last updated by the study team

2014-08-15

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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
• 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.

You may not qualify if…

• 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)
• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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