NCT01819844

Brief Summary

The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 21, 2017

Completed
Last Updated

December 12, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

February 28, 2013

Results QC Date

November 1, 2016

Last Update Submit

November 13, 2017

Conditions

Diabetes MellitusHyperglycemia

Keywords

Closed-loop blood glucose controlContinuous glucose monitoringBionic pancreasArtificial pancreas

Outcome Measures

Primary Outcomes (1)

  • Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.

    12 hours

Secondary Outcomes (9)

  • Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol

    12 hours

  • Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements

    12 hours

  • Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl

    12 hours

  • Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm

    12 hours

  • Number of BG Events < 70 mg/dl as Determined by the CGM

    12 hours

  • +4 more secondary outcomes

Study Arms (1)

Closed-loop blood glucose control

EXPERIMENTAL

Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is \> 1 u/kg or \> 2 u/kg.

Device: Closed-loop blood glucose control

Interventions

Closed-loop blood glucose controlDEVICE

The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose \> 2 u/kg).

Also known as: InPatient Closed-Loop Blood Glucose Control Device.
Closed-loop blood glucose control

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with type 1 diabetes
  • Age 21 to 75 with clinical type 1 diabetes for at least one year
  • Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
  • Total daily dose (TDD) of insulin that is \< 1 u/kg
  • Subjects with type 2 diabetes
  • Age 21 to 75 with clinical type 2 diabetes for at least one year
  • Diabetes managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin
  • Total daily dose (TDD) of insulin that is \> 1 u/kg/day but \< 2 u/kg/day or \> 2 u/kg/day

You may not qualify if:

  • Pregnancy
  • Renal insufficiency
  • Cancer
  • Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
  • Acute illness or exacerbation of chronic illness at the time of the study procedure
  • Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin
  • History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders
  • Known history of coronary artery disease, TIA or stroke
  • History of seizures
  • Transaminitis
  • Stage 2 hypertension at the time of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH Diabetes Research Center

Boston, Massachusetts, 02114, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Steven J. Russell
Organization
Massachusetts General Hospital
sjrussell@partners.org
617-726-8722

Study Officials

  • Steven J Russell, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 28, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

December 12, 2017

Results First Posted

July 21, 2017

Record last verified: 2017-11

Locations

US(1)