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

NCT01582139 | Completed Results

• 2 other identifiers: 159705R21DK085641
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. Investigators will also be studying to see if information about heart rate can help the AP Platform reduce hypoglycemia related to exercise.

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas Project; AP Platform; Insulin Pump; Continuous Glucose Monitor; Closed-Loop Control; Control-to-Range

Outcome Measures

Primary Outcomes (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.

  26 hours (x2 admissions)

Secondary Outcomes (3)

• Low Blood Glucose Index

  26 hours (x2 admissions)

• Average Glucose Drop

  26 hours (2x admissions)

• Time in Range

  26 hours (x2 admissions)

Study Arms (2)

Experimental Condition: (Heart-Rate Informed SSM+HMM)

EXPERIMENTAL

An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate

Device: Heart rate informed SSM+HMM

Control Condition (SSM+HMM)

NO INTERVENTION

A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.

Interventions

Heart rate informed SSM+HMM DEVICE

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.

Experimental Condition: (Heart-Rate Informed SSM+HMM)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• DexCom, Inc.: collaborator
• Insulet Corporation: collaborator
• Abbott Diabetes Care: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 24702135 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Marc D Breton, Ph.D.
• Organization: University of Virginia

mb6nt@virginia.edu

434-982-6484

Study Officials

• Marc Breton, Ph.D.

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

US (1)