An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas

NCT02536950 | Completed DMC

• 1 other identifier: IRB34914
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.

Conditions

Diabetes Mellitus, Type 1

Keywords

bionic pancreas; closed-loop control; artificial pancreas

Outcome Measures

Primary Outcomes (1)

• Mean glucose

  Dexcom G4P AP mean glucose

  change over 5 days

Secondary Outcomes (7)

• % time <50 mg/dl

  change over 5 days

• % time <70 mg/dl

  change over 5 days

• % time 70-120 mg/dl

  change over 5 days

• % time 70-180 mg/dl

  change over 5 days

• % time >180 mg/dl

  change over 5 days

Study Arms (3)

Blinded Sensor

NO INTERVENTION

Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week

Fixed set point

EXPERIMENTAL

Subjects will be in a hotel and use a fixed set point for glucose control for two days initialized at 130 mg/dl. The setpoint will be adjusted, if necessary, over the two days in the hotel before they are sent home for 5 days

Device: Fixed set point

Variable Set Point

EXPERIMENTAL

Subjects will begin using a "variable" setpoint which will make adjustments based on their past glucose control over the previous day

Device: Variable set point

Interventions

Fixed set point DEVICE

Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting.

Fixed set point

Variable set point DEVICE

Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window.

Variable Set Point

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetes for at least 1 year
• insulin pump for ≥ 6 months
• Prescription medication regimen stable for \> 1 month
• Subject comprehends written English
• Female patients who are sexually active must be on acceptable method of contraception e.g. oral contraceptive pill, diaphragm, IUD (Intrauterine Device)
• Female patients must have a negative urine pregnancy test
• Informed Consent Form signed by the subject
• Lives and works within a 60 minute drive-time radius of Stanford University
• Willing to remain within a 60 minute drive-time radius of Stanford University during all 3 of the 7-day study arms (21 days)
• Have someone over 18 years of age who lives with them,

You may not qualify if:

• Current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days), use of marijuana within 1 month of enrollment, or other substance abuse (use within the last 6 months of controlled substances other than marijuana without a prescription)
• Subject has a history of diagnosed medical eating disorder
• Subject has a history of visual impairment which would not allow subject to participate
• Subject has an active skin condition that would affect sensor placement
• Subject has adhesive allergies
• Subjects requiring an intermediate or long-acting insulin (such as NPH, Neutral Protamine Hagedorn, detemir or glargine)
• Subjects requiring other anti-diabetic medications other than insulin (oral or injectable)
• Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
• Unwilling or unable to refrain from drinking more than 2 drinks in an hour or more than 4 drinks in a day or use of marijuana during the trial
• Subject has active Graves' disease
• Subjects with inadequately treated thyroid disease or celiac disease
• History of liver disease Renal failure on dialysis
• Personal history of cystic fibrosis, pancreatitis, pancreatic tumor, or any other pancreatic disease besides type 1 diabetes
• Any known history of coronary artery disease
• Abnormal EKG (electrocardiogram) consistent with coronary artery disease or increased risk of malignant arrhythmia

Sponsors & Collaborators

• Bruce A. Buckingham: lead
• Boston University: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, 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

Study Officials

• Bruce A Buckingham, MD

  Stanford School of Medicine, Pediatric Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics (Endocrinology), MD

Study Record Dates

• First Submitted: July 18, 2015
• First Posted: September 1, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)