Inpatient Evaluation of an Automated Closed-Loop Control-to-Range System

NCT01271023 | Completed Phase 1 DMC

• 1 other identifier: CTR
• Study Type: interventional
• Target: 57
• Locations: 4 countries
• Sites: 7

Brief Summary

The purpose of this study is to test an insulin management system ("Control-to-Range (CTR) system") in an inpatient setting to see if the system is safe and effective enough to test in a future at-home study. The system includes (1) a DexCom Seven Plus Continuous Glucose Monitoring (CGM) device that measures the blood sugar, (2) a laptop computer that determines how much insulin is needed, and (3) an Insulet OmniPod insulin pump that delivers the insulin. The study will include two hospital stays consisting of meals and exercise scenarios. Both hospital stays will be for 24+ hours during the day and night. The study will include about 50 individuals at 7 clinical centers in the United States, France, Israel, and Italy.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (6)

• Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit

  Group success criterion defined as a mean blood glucose \>50%, lower end of one-sided 95% confidence interval \>40% and individual criterion of no individual \<30%.

  Admission Visit 1

• Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus

  Success is defined as \>=40% subjects with a blood glucose in the 71-180 mg/dL range.

  4 hours following the breakfast with a missed meal bolus

• Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount

  Success is defined as \>=50% subjects with a blood glucose in the 71-180 mg/dL range.

  5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount

• Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise

  Success is defined as less than 25% of subjects with a blood glucose nadir \<=60 mg/dL.

  Following exercise completion

• Overall frequency of hypoglycemia

  Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.

  Includes both admission visits

• Overall frequency of hyperglycemia

  Success defined as no subjects with diabetic ketoacidosis (DKA).

  Includes both admission visits

Secondary Outcomes (8)

• Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit

  Admission Visit Day 1 (9:00AM-11:00PM)

• Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit

  Admission Visit Night 1 (11:00PM-8:00AM)

• Percent of blood glucose values >400 mg/dL during the first admission visit

  Admission Visit 1

• Percent of blood glucose values <=60 mg/dL during the first admission visit

  Admission Visit 1

• Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus

  4 hours following the breakfast with a missed meal bolus

Study Arms (1)

Closed-Loop Control

EXPERIMENTAL

The Control to Range algorithm will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.

Device: Control-to-Range Automated Insulin Management System

Interventions

Control-to-Range Automated Insulin Management System DEVICE

The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter. The Closed-Loop Control System will be used during all 3 admission visits.

Closed-Loop Control

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Age 12 to 65 years
• Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
• For females, not currently known to be pregnant
• Demonstration of proper mental status and cognition for the study
• An understanding of and willingness to follow the protocol and sign the informed consent or assent

You may not qualify if:

• Diabetic ketoacidosis in the past 6 months
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
• History of a seizure disorder (except hypoglycemic seizure). Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist treatment for a seizure disorder
• Coronary artery disease or heart failure. Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
• Cystic fibrosis
• Active infection
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
• Presence of a known adrenal disorder
• Abnormal liver or renal function (Transaminase \>2 times the upper limit of normal, Creatinine \> 1.5 mg/dL)
• Active gastroparesis
• 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
• Uncontrolled thyroid disease
• Abuse of alcohol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
• A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol

Sponsors & Collaborators

• Jaeb Center for Health Research: lead

Study Sites (7)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado Health Sciences Center- Barbara Davis

Aurora, Colorado, 80045, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

University of Padova

Padua, 93106, Italy

Location

Related Publications (2)

• Chase HP, Doyle FJ 3rd, Zisser H, Renard E, Nimri R, Cobelli C, Buckingham BA, Maahs DM, Anderson S, Magni L, Lum J, Calhoun P, Kollman C, Beck RW; Control to Range Study Group. Multicenter closed-loop/hybrid meal bolus insulin delivery with type 1 diabetes. Diabetes Technol Ther. 2014 Oct;16(10):623-32. doi: 10.1089/dia.2014.0050. Epub 2014 Sep 4.

  PMID: 25188375 DERIVED

• Zisser H, Renard E, Kovatchev B, Cobelli C, Avogaro A, Nimri R, Magni L, Buckingham BA, Chase HP, Doyle FJ 3rd, Lum J, Calhoun P, Kollman C, Dassau E, Farret A, Place J, Breton M, Anderson SM, Dalla Man C, Del Favero S, Bruttomesso D, Filippi A, Scotton R, Phillip M, Atlas E, Muller I, Miller S, Toffanin C, Raimondo DM, De Nicolao G, Beck RW; Control to Range Study Group. Multicenter closed-loop insulin delivery study points to challenges for keeping blood glucose in a safe range by a control algorithm in adults and adolescents with type 1 diabetes from various sites. Diabetes Technol Ther. 2014 Oct;16(10):613-22. doi: 10.1089/dia.2014.0066. Epub 2014 Jul 8.

  PMID: 25003311 DERIVED

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

Study Officials

• Roy W Beck, MD, PhD

  Jaeb Center for Health Research

  STUDY DIRECTOR

• Howard Zisser, MD

  Sansum Diabetes Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 6, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

FR (1); IT (1); IL (1); US (4)