Single Hormone Closed Loop Study With PDT Sensor

NCT03528174 | Completed Results FDA Device

• 1 other identifier: 18241
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study described within this protocol is designed to test a single hormone closed-loop algorithm for managing blood glucose in type 1 diabetes using insulin only and a new device for measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery. Subjects will undergo one all day closed loop study using insulin only. The closed loop insulin only system includes a Dexcom G5 transmitter, a Nexus 5 smart phone and two Tandem tslim pumps connected to two Pacific Diabetes Technologies glucose sensing cannulas. The closed loop system will be started after G5 2 hour sensor start-up with an IV catheter for frequent blood withdrawal for 10 hours.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean Absolute Relative Difference of Sensed Glucose Values

  Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values.

  up to 10 hours

Secondary Outcomes (13)

• Percent of Time With Sensed Glucose Between 70-180 mg/dl

  up to 10 hours

• Percent of Time With Sensed Glucose Less Than 70 mg/dl

  up to 10 hours

• Percent of Time With Sensed Glucose Less Than 54 mg/dl

  up to 10 hours

• Percent of Time With Sensed Glucose Greater Than 250 mg/dl

  up to 10 hours

• Mean Sensed Glucose

  up to 10 hours

Study Arms (1)

Single Hormone closed loop

EXPERIMENTAL

Subjects will have glucose managed using the Artificial Pancreas Control system (APC) using insulin only. Insulin will be infused through the Pacific Diabetes Technologies CGM Insulin Infusion system.

Device: Artificial Pancreas Control system (APC); Device: Pacific Diabetes Technologies CGM Insulin Infusion system

Interventions

Artificial Pancreas Control system (APC) DEVICE

This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.

Single Hormone closed loop

Pacific Diabetes Technologies CGM Insulin Infusion system DEVICE

An integrated combination CGM/insulin infusion system

Single Hormone closed loop

Eligibility Criteria

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

You may qualify if:

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Male or female subjects 21 to 65 years of age.
• Current use of an insulin pump for at least 3 months with stable insulin pump settings for \> 2 weeks.
• HbA1c ≤ 10% at screening.
• Body Mass Index ≥ 22.
• Total daily insulin requirement is less than 200 units/day.
• 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 reported 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 36% for men, less than 32% for women.
• History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.
• History of Diabetic Ketoacidosis during the prior 6 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
• 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

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: Jessica Castle MD
• Organization: Oregon Health and Science University

castleje@ohsu.edu

503-494-7072

Study Officials

• Jessica Castle, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Peter Jacobs, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 17, 2018
• Study Start: April 16, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)