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Crossover Feasibility Study of Portable AP Device With Zone-MPC and HMS and Adapted I:C and Basal Insulin

Information source: William Sansum Diabetes Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: portable Artificial Pancreas (Device)

Phase: Phase 0

Status: Active, not recruiting

Sponsored by: William Sansum Diabetes Center

Summary

The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1 diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to compare closed-loop control with or without optimization of initialization parameters related to basal insulin infusion rates and insulin to carbohydrate (I: C) ratios for meals and snacks.

Clinical Details

Official title: Randomized Crossover Feasibility Study of Artificial Pancreas Device (AP) Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) With and Without Basal and Insulin-to-Carbohydrate Bolus Initialization

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: time spent in safe blood glucose range

Secondary outcome: glucose level extremes and need for outside intervention

Detailed description: The study consists of an evaluation of the Artificial Pancreas device system during two 24-27. 5-hour closed-loop phases in an outpatient/hotel environment. Prior to the closed-loop phases, each subject will undergo a 7-day data collection period consisting of his or her usual free-living conditions along with 3 meals of known carbohydrate content. Data from the insulin pump, a continuous glucose monitoring sensor (CGM), diet and exercise records will be collected during this period. These data from this 7-day period will be analyzed in order to come up with adapted basal insulin infusion rates and bolus insulin to carbohydrate (I: C) ratios.

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump

for at least 6 months with commercially available rapid acting insulin

- The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide

level and antibody determinations are not needed.

- Age 21 to 65 years

- For females, not currently known to be pregnant or nursing

- HbA1c ≤ to 10%, as measured with DCA2000 or equivalent device

- Willing to perform the calibration of the study CGMs using a finger stick only and

willing to follow instructions for insulin pump and CGM wear.

- Willing to use the study CGM and study insulin pump during closed-loop.

- Able to and agrees to avoid the following medication starting 24 hours before sensor

wear through completion of the close loop study visit: acetaminophen, prednisone, and pseudoephedrine.

- An understanding of and willingness to follow the protocol and sign the informed

consent. Exclusion Criteria:

- Pregnancy (as determined by a positive blood pregnancy test performed in females of

childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.

- Females who are sexually active and able to conceive that do not use contraception.

- Any documented arrhythmias.

- Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency

room visit or hospitalization

- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months

prior to enrollment

- Current treatment for a seizure disorder; Subjects with a history of seizures may be

included in the study if they receive written clearance from their neurologist

- Active infection

- A known medical condition that in the judgment of the investigator might interfere

with the completion of the protocol such as cognitive deficit.

- Mental incapacity, unwillingness or language barriers precluding adequate

understanding or co-operation, including subjects not able to read or write.

- 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

- Presence of a known adrenal disorder

- 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. Adequately treated thyroid disease and celiac disease

do not exclude subjects from enrollment

- Abuse of alcohol

- 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

- Current use of a beta blocker medication

- Hematocrit < 30% or >55%

- A1C > 10%

- Abnormal liver or renal function (Transaminase >2 times the upper limit of normal,

Creatinine> 1. 5 mg/dL)

- Labs drawn at screening visit or within one month prior to screening (for other

purposes) will suffice for enrollment purposes related to hematocrit

- Subject has skin conditions that, in the determination of the investigator, would

preclude wearing the study devices (infusion set and sensor), in the abdomen. Examples include but are not limited to: psoriasis, burns, scaring, eczema, tattoos, and significant hypertrophy at sites of device wear; any known allergy to medical adhesives.

- Currently on long-term treatment using prednisone.

- If subject had been on short term treatment of prednisone, defer enrollment until

underlying condition and prednisone treatment have resolved.

- Allergy to study drug, food or other study material.

- Clinically significant screening ECG, physical examination, laboratory test, or vital

sign abnormality.

- Exposure to any investigational drug within 30 days.

- History of malignancy within the 5 years before screening (other than basal cell

carcinoma).

- Currently smoking or discontinued smoking (including cigarettes, cigars, pipes) over

the past 6 months.

- Highly sensitive to insulin: insulin-to-carbohydrate ratio I: C > 1: 12

- Current participation in another investigational trial.

Locations and Contacts

Sansum Diabetes Research Institutute, Santa Barbara, California 93105, United States
Additional Information

Starting date: November 2013
Last updated: October 27, 2014

Page last updated: August 23, 2015

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