Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes

NCT01939834 | Terminated Results

• 1 other identifier: 16930
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use an Advisory/Automated Adaptive (AAA) or Closed-Loop Control (CLC) system for insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. A component of this study evaluated AAA or CLC Control overnight only in 5 consecutive overnights in a cross-over trial with sensor-augmented pump therapy occurring prior to or following CLC overnight. Another component of this study planned evaluating if the AAA Control system run on the Diabetes Assistant (DiAs) system can prevent hypoglycemia during and following exercise more efficiently during a 40 hour trial this part of the trial was not conducted due to a preference for overnight only configuration in pilot testing. This protocol represents a culmination of prior clinical trials in development of this AAA system and benefits from the synthesis of those components.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus; Artificial Pancreas; Diabetes Assistant (DiAs); Continuous Glucose Monitor

Outcome Measures

Primary Outcomes (1)

• Time in Range Overnight

  For subjects participating in consecutive overnight control, will assess time in range (80-140mg/dL) overnight in closed loop control compared to sensor-augmented pump therapy.

  5 consecutive nights

Secondary Outcomes (2)

• Evaluating the Risk for Hypoglycemia as Measured by the Low Blood Glucose Index

  5 consecutive nights

• Time Within Target Range

  5 consecutive nights

Study Arms (2)

Overnight CLC followed by SAP

EXPERIMENTAL

Throughout the trial, participants wore a study CGM. Participants spent 5 nights in a supervised outpatient setting using closed-loop control (CLC) system running on DiAs from 23:00 to 07:00. The participants then subsequently had a week at home in which they wore either their personal pump (UVA) or the study pump (Italy) along with a continuous glucose monitor without running in any specialized mathematical equations (sensor-augmented pump therapy or SAP). Four fingersticks completed each day and carbohydrates will be recorded in bolus calculator of their insulin pump prior to each meal.

Device: Overnight CLC; Device: Sensor-Augmented Pump Therapy (SAP)

SAP followed by Overnight CLC

EXPERIMENTAL

Throughout the trial, participants wore a study CGM. Participants in this arm spent a week had a week at home in which they wore either their personal pump (UVA) or the study pump (Italy) along with a continuous glucose monitor without running in any specialized mathematical equations (sensor-augmented pump therapy or SAP). They subsequently spent 5 nights in a supervised outpatient setting using closed-loop control (CLC) system running on DiAs from 23:00 to 07:00. Four fingersticks completed each day and carbohydrates will be recorded in bolus calculator of their insulin pump prior to each meal.

Device: Overnight CLC; Device: Sensor-Augmented Pump Therapy (SAP)

Interventions

Overnight CLC DEVICE

Overnight Closed-Loop Control (CLC) is run on the DiAs which is a medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump. The cell phone runs the CLC and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range.

Overnight CLC followed by SAP; SAP followed by Overnight CLC

Sensor-Augmented Pump Therapy (SAP) DEVICE

The subject will be on their home insulin pump (UVA) or study pump (Italy) and using a CGM per their usual care.

Overnight CLC followed by SAP; SAP followed by Overnight CLC

Eligibility Criteria

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

You may qualify if:

• ≥21 and \<65 years old.
• Clinical diagnosis of type 1 diabetes mellitus. For an individual to be enrolled at least one criterion from each list must be met.
• o Criteria for documented hyperglycemia (at least 1 must be met): i. Fasting glucose ≥126 mg/dL - confirmed ii. Two-hour Oral Glucose Tolerance Test glucose ≥200 mg/dL - confirmed iii. Hemoglobin A1C (HbA1c) ≥6.5% documented - confirmed iv. Random glucose ≥200 mg/dL with symptoms v. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
• o Criteria for requiring insulin at diagnosis (1 must be met): i. Participant required insulin at diagnosis and continually thereafter ii. 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 iii. Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually
• Use of an insulin pump to treat his/her diabetes for at least 1 year.
• Familiarity with a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate ratio, insulin sensitivity factor (ISF), target glucose and active insulin.
• HbA1c \<9% 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 24 hours prior to and during CGM use.
• Ability to access the Internet and upload CGM data via the company software during the data collection period.
• 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:

• Severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic ketoacidosis within the 12 months prior to enrollment.
• Pregnancy; breast feeding, or intention of becoming pregnant.
• Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg).
• Conditions which may increase the risks associated with possible hypoglycemia, such as any active cardiac disorder/arrhythmia, uncontrolled coronary artery disease during the previous year (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, uncontrolled adrenal insufficiency, neurologic disease or atrial fibrillation.
• Self-reported hypoglycemia unawareness.
• 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).
• Anticoagulant therapy other than aspirin.
• Oral steroids.
• Subjects currently taking Amylin.
• Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study sessions.
• Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment).
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• Known current or recent alcohol or drug abuse.
• Medical conditions that would make operating a CGM, the Diabetes Assistant (DiAs) cell phone or insulin pump difficult (e.g. blindness, severe arthritis, immobility).

Sponsors & Collaborators

• Sue Brown: lead
• DexCom, Inc.: collaborator
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Brown SA, Kovatchev BP, Breton MD, Anderson SM, Keith-Hynes P, Patek SD, Jiang B, Ben Brahim N, Vereshchetin P, Bruttomesso D, Avogaro A, Del Favero S, Boscari F, Galasso S, Visentin R, Monaro M, Cobelli C. Multinight "bedside" closed-loop control for patients with type 1 diabetes. Diabetes Technol Ther. 2015 Mar;17(3):203-9. doi: 10.1089/dia.2014.0259. Epub 2015 Jan 16.

  PMID: 25594434 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: Sue Brown
• Organization: University of Virginia

sab2f@virginia.edu

434-924-1825

Study Officials

• Sue Brown, MD

  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: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: September 11, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-04

Locations

US (1)