MMPPC Outpatient Clinical Protocol 2016

NCT02769884 | Completed Phase 2

• 1 other identifier: MMPPC- outpatient-2016
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study trials a prototype artificial pancreas system that consists of a Roche insulin pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model probabilistic predictive control) algorithm housed on an android cell phone. The system doses insulin based on CGM sensor glucose levels and the experimental algorithm. The aim of this clinical study is to determine the efficacy of the MMPPC controller in adolescents and adults with type 1 diabetes in a hotel setting.

Conditions

Type 1 Diabetes

Keywords

artificial pancreas

Outcome Measures

Primary Outcomes (2)

• Mean CGM glucose value

  Average CGm glucose value during the experimental trial

  72 hours

• CGM percent time < 60 mg/dl

  Percent of time the CGM was reading \<60 mg/dl

  72 hours

Secondary Outcomes (14)

• CGM percent time < 50 mg/dl

  72 hours

• CGM percent time < 70 mg/dl

  72 hours

• % 70-140 mg/dl

  72 hours

• % 70-180 mg/dl

  72 hours

• % CGM >180 mg/dl

  72 hours

Other Outcomes (5)

• Comparison of Announced and Unannounced Meals

  72 hours

• Safety Criteria 1: No more than 3 SMBG values < 50 mg/dL per subject

  72 hours

• Safety Criteria 2: No more than 2 episodes with SMBG value >300 mg/dL for >1 hour not due to infusion set failure per subject

  72 hours

Study Arms (1)

MMPPC arm

EXPERIMENTAL

Subjects in this arm will wear the experimental MMPPC algorithm artificial pancreas for 72 hours in a hotel/house setting. The study period will involve unannounced meals and exercise

Device: MMPPC algorithm artificial pancreas

Interventions

MMPPC algorithm artificial pancreas DEVICE

An artificial pancreas system using the MMPPC algorithm, Roche insulin pump, and Dexcom CGM

MMPPC arm

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Diabetic ketoacidosis in the past 6 months
• Hypoglycemic seizure or loss of consciousness in the past 6 months
• Hypoglycemia unawareness as defined by no recognition of hypoglycemia until the glucose is \<60 mg/dL and no adrenergic symptoms at glucose of 60 mg/dL (shakiness, palpitations, diaphoresis). Subjects will also be administered the Clark questionnaire for hypoglycemia unawareness. If they have a score ≥ 4, they are excluded from the study
• Subjects requiring an intermediate or long-acting insulin (such as NPH, detemir or glargine)
• Subjects using other anti-diabetic medications other than insulin (oral or injectable) at the time of enrollment. Any prior use of other anti-diabetic medications must be washed out for at least 8 weeks prior to enrollment.
• Current use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study
• Subject has a medical disorder that in the judgment of the investigator will affect completion of any aspect of the protocol
• Subject is currently participating in another investigational device or drug study within 30 days or 5-half lives of the drug.
• Subject has a history of any cardiac or vascular disorder including, but not limited to, myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, arrhythmia or thromboembolic disease
• Subject has a history of hepatic disease
• Subject has renal failure on dialysis
• Systolic blood pressure \> 160 mmHg on screening visit
• Diastolic blood pressure \> 90 mmHg on screening visit
• Subjects with inadequately treated thyroid disease or celiac disease
• Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol

Sponsors & Collaborators

• Rensselaer Polytechnic Institute: lead
• Stanford University: collaborator
• University of Colorado, Denver: collaborator
• Mount Sinai Hospital, New York: collaborator

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: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Chemical & Biological Engineering

Model Details: Use the MMPPC system for 72 hours in a hotel setting

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 12, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share