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

NCT01929798 | Completed Early Phase 1

• 1 other identifier: DP301
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

artificial pancreas

Outcome Measures

Primary Outcomes (1)

• time spent in safe blood glucose range

  The percentage time spent in safe blood glucose range of \[80-140\] mg/dl will be the primary endpoint. More time spent inside the desired range will be considered successful. Expected levels are \[70-180\] mg/dl the 5 hours after meals and \[70-150\] mg/dl 3 hours after exercise.

  24-hour closed-loop

Secondary Outcomes (1)

• glucose level extremes and need for outside intervention

  24-hour closed loop

Study Arms (2)

Optimized basal/bolus with artificial pancreas

EXPERIMENTAL

Portable artificial pancreas with optimization

Device: portable Artificial Pancreas

Nominal basal/bolus treatment

NO INTERVENTION

Portable artificial pancreas without optimization.

Interventions

portable Artificial Pancreas DEVICE

The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on measured glucose levels.

Optimized basal/bolus with artificial pancreas

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• University of Virginia: collaborator
• Mayo Clinic: collaborator
• University of California, Santa Barbara: collaborator
• University of Padova: collaborator

Study Sites (1)

Sansum Diabetes Research Institutute

Santa Barbara, California, 93105, United States

Location

Related Publications (1)

• Dassau E, Brown SA, Basu A, Pinsker JE, Kudva YC, Gondhalekar R, Patek S, Lv D, Schiavon M, Lee JB, Dalla Man C, Hinshaw L, Castorino K, Mallad A, Dadlani V, McCrady-Spitzer SK, McElwee-Malloy M, Wakeman CA, Bevier WC, Bradley PK, Kovatchev B, Cobelli C, Zisser HC, Doyle FJ 3rd. Adjustment of Open-Loop Settings to Improve Closed-Loop Results in Type 1 Diabetes: A Multicenter Randomized Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3878-86. doi: 10.1210/jc.2015-2081. Epub 2015 Jul 23.

  PMID: 26204135 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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 28, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (1)