Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia
1 other identifier
interventional
12
1 country
1
Brief Summary
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 19, 2013
September 1, 2013
2 months
June 28, 2013
September 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting
Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold. Ability of the system to issue timely and accurate warnings.
1 week after subject is enrolled in the study
Secondary Outcomes (1)
Capturing the number of Adverse Events as a measure of assessing subject safety
1 week after subject is enrolled in the study
Study Arms (1)
type 1 diabetes
EXPERIMENTALPredictive Low Glucose Minimizer (PLGM) System
Interventions
This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Eligibility Criteria
You may qualify if:
- Age 21-65 years
- Type 1 diabetes mellitus for at least one year
- Currently using an insulin infusion pump for at least the past 6 months
You may not qualify if:
- Pregnancy
- History of Diabetic Ketoacidosis (DKA) in the past six months
- History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsum Diabetes Reserach Inst.
Santa Barbara, California, 93105, United States
Related Publications (1)
Finan DA, Dassau E, Breton MD, Patek SD, McCann TW Jr, Kovatchev BP, Doyle FJ 3rd, Levy BL, Venugopalan R. Sensitivity of the Predictive Hypoglycemia Minimizer System to the Algorithm Aggressiveness Factor. J Diabetes Sci Technol. 2015 Jun 30;10(1):104-10. doi: 10.1177/1932296815593292.
PMID: 26134834DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Zisser, MD
Samsum Diabetes Reserach Inst.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2013
First Posted
August 9, 2013
Study Start
July 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 19, 2013
Record last verified: 2013-09