Four Way Crossover Closed Loop With Exercise Detection

NCT02862730 | Completed Results

• 1 other identifier: 15590
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is the low glucose suspend safety feature now available from Medtronic (MiniMed 530G with Enlite). The study described within this protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin only mode with predictive low glucose suspend, all with an exercise detection algorithm. The purpose of this study is to determine whether a dual hormone AP with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm and sensor augmented pump therapy using the subject's own insulin pump.

Conditions

Type 1 Diabetes

Keywords

diabetes; closed-loop; dual hormone; exercise

Outcome Measures

Primary Outcomes (4)

• Percent of Time With Sensed Glucose < 3.9 mmol/L

  Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.

  entire 84 hour study

• Percent of Time With Sensed Glucose < 3.9 mmol/L

  Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.

  From 14:00-18:00 for each 12 hour inpatient visit

• Percent of Time With Sensed Glucose Between 3.9-10 mmol/L

  Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.

  entire 84 hour study

• Percent of Time With Sensed Glucose Between 3.9-10 mmol/L

  Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.

  From 14:00-18:00 for each 12 hour inpatient visit

Secondary Outcomes (8)

• Mean Sensed Glucose

  entire 84 hour study

• Number of Carbohydrate Treatments

  entire 84 hour study

• Percent of Time With Sensed Glucose < 3.0 mmol/L

  entire 84 hour study

• Percent of Time With Sensed Glucose > 10 mmol/L

  entire 84 hour study

• Number of Events With Capillary Blood Glucose < 3.9 mmol/L

  entire 84 hour study

Study Arms (4)

Predictive Low Glucose Suspend Arm

EXPERIMENTAL

Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient. The predictive low glucose suspend system will run through the artificial pancreas controller in predictive low glucose suspend mode and utilize the patient's optimized basal rates, correction factor, and carb ratio, but it will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.

Device: Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode

Dual Hormone Closed-loop Arm

EXPERIMENTAL

Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in dual hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery and an increase in glucagon delivery upon detection.

Device: Artificial Pancreas Controller in Dual Hormone Mode

Single Hormone Closed-loop Arm

EXPERIMENTAL

Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient using the closed-loop artificial pancreas controller in single hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery upon detection.

Device: Artificial Pancreas Controller in Single Hormone Mode

Sensor Augmented Pump Therapy arm

ACTIVE COMPARATOR

Subjects will undergo an 84 hour study with 24 hours inpatient and 60 hour outpatient with subject's insulin pump and glucose sensor, if he/she typically uses one. Subjects will still wear a heart rate monitor uploading to a smart phone.

Device: Subject's insulin pump

Interventions

Artificial Pancreas Controller in Dual Hormone Mode DEVICE

The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.

Also known as: APC

Dual Hormone Closed-loop Arm

Subject's insulin pump DEVICE

Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.

Sensor Augmented Pump Therapy arm

Artificial Pancreas Controller in Single Hormone Mode DEVICE

The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.

Single Hormone Closed-loop Arm

Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode DEVICE

The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.

Predictive Low Glucose Suspend Arm

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
• Current use of an insulin pump.
• Lives with another person age 18 or older who will be present while subject exercises at home and that can attend the training on using the system with the subject.
• Lives within 20 miles of OHSU.
• A1C\<10%
• Willingness to follow all study procedures, including attending all clinic visits.
• Willingness to sign informed consent and HIPAA documents.

You may not qualify if:

• Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
• Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
• Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
• Hematocrit of less than or equal to 34%.
• Hypertensive subjects with systolic blood pressure \>= 160 mmHg or diastolic blood pressure \>= 100 mmHg despite treatment or who have treatment-refractory hypertension (e.g. requiring four or more medications).
• History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Subjects will complete a hypoglycemia awareness questionnaire. Subjects will be excluded for four or more R responses.
• Adrenal insufficiency.
• Any active infection.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Seizure disorder.
• Active foot ulceration.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Major surgical operation within 30 days prior to screening.
• Use of an investigational drug within 30 days prior to screening.
• Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Castle JR, El Youssef J, Wilson LM, Reddy R, Resalat N, Branigan D, Ramsey K, Leitschuh J, Rajhbeharrysingh U, Senf B, Sugerman SM, Gabo V, Jacobs PG. Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors. Diabetes Care. 2018 Jul;41(7):1471-1477. doi: 10.2337/dc18-0228. Epub 2018 May 11.

  PMID: 29752345 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jessica Castle
• Organization: Oregon Health and Science University

castleje@ohsu.edu

503-494-7072

Study Officials

• Jessica Castle, MD

  Oregon Health and Science University

  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: July 28, 2016
• First Posted: August 11, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: January 31, 2018
• Last Updated: September 14, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)