NCT00811317

Brief Summary

We hypothesize that our integrated closed-loop glucose-control system can provide effective, tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the feasibility of closed-loop BG control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

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

Study Start

First participant enrolled

May 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2008

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

October 25, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

May 29, 2008

Results QC Date

April 18, 2017

Last Update Submit

October 24, 2017

Conditions

Type 1 Diabetes

Keywords

diabetesglucosehyperglycemiahypoglycemiainsulinglucagoncounter-regulationclosed-loopfeedbackcontroldual-infusionsubcutaneousautomatedartificial pancreasintensive insulin therapy

Outcome Measures

Primary Outcomes (1)

  • Average Blood Glucose Over the Closed-loop Control Period

    24 hours

Secondary Outcomes (22)

  • Percentage of Time Spent Within 70-180 mg/dl

    24 hours

  • Peak Hyperglycemia Following Each Meal

    After each of 3 meals

  • Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals

    After each of 3 meals

  • Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target)

    24 hours

  • Percentage of Time Spent With BG < 70 mg/dl

    24 hours

  • +17 more secondary outcomes

Study Arms (1)

Closed-loop

EXPERIMENTAL

Type 1 diabetic subjects under closed-loop blood glucose control

Device: Closed-loop

Interventions

Closed-loopDEVICE

Computer algorithm developed by Firas El-Khatib and Edward Damiano at Boston University that controls sub-cutaneous infusion of insulin and glucagon to regulate blood glucose to target

Closed-loop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Clinical type 1 diabetes for at least five years
  • Otherwise healthy (mild chronic disease allowed if well controlled)
  • Diabetes managed using an insulin infusion pump
  • Body mass index (BMI) between 20 and 31
  • Total daily dose (TDD) of insulin ≤ 1 U/kg and ≤ 100 U/day
  • Post-prandial C-peptide \< 0.1 nmol/L at 90 minutes in a mixed meal (Sustacal) tolerance test by the DCCT method
  • Hemoglobin A1c less than or equal to 8.5%
  • Prescription medication regimen stable for at least 1 month
  • Age 18 years or older
  • No personal history of diabetes, impaired fasting glucose, or impaired glucose tolerance
  • No personal history of pancreatic disease
  • Not taking medication that may affect glucose, insulin, or glucagon dynamics
  • Otherwise healthy (mild chronic disease allowed if well controlled)
  • Body mass index (BMI) between 20 and 31
  • +1 more criteria

You may not qualify if:

  • Unable to provide informed consent or are unable to comply with study procedures
  • Current participation in another clinical trial
  • Anemia (HCT or hemoglobin less than normal for sex)
  • Elevated alanine aminotransferase (ALT \> 3 fold above upper limit of normal)
  • Untreated or inadequately treated hyperthyroidism or hypothyroidism (abnormal TSH or free T4)
  • Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception
  • Progressive or proliferative diabetic retinopathy (subjects with mild, non-proliferative background retinopathy or stable disease previously treated with photocoagulation are not excluded).
  • Renal insufficiency (creatinine clearance estimated by Cockcroft-Gault equation of ≤ 50 ml/min)
  • Any known history or symptoms of coronary artery disease.
  • Abnormal EKG
  • Congestive heart failure
  • History of TIA or stroke within preceding 6 months
  • Acute illness or exacerbation of chronic illness at the time of the study procedure
  • Change in medication regimen in the 30 days prior to enrollment
  • History of seizures
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • El-Khatib FH, Jiang J, Gerrity RG, Damiano ER. Pharmacodynamics and stability of subcutaneously infused glucagon in a type 1 diabetic Swine model in vivo. Diabetes Technol Ther. 2007 Apr;9(2):135-44. doi: 10.1089/dia.2006.0006.

    PMID: 17425438BACKGROUND

  • El-Khatib FH, Jiang J, Damiano ER. Adaptive closed-loop control provides blood-glucose regulation using dual subcutaneous insulin and glucagon infusion in diabetic Swine. J Diabetes Sci Technol. 2007 Mar;1(2):181-92. doi: 10.1177/193229680700100208.

    PMID: 19888405BACKGROUND

  • El-Khatib FH, Jiang J, Damiano ER. A feasibility study of bihormonal closed-loop blood glucose control using dual subcutaneous infusion of insulin and glucagon in ambulatory diabetic swine. J Diabetes Sci Technol. 2009 Jul 1;3(4):789-803. doi: 10.1177/193229680900300428.

    PMID: 20144330BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusHyperglycemiaHypoglycemiaInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Results Point of Contact

Title
Steven Russell
Organization
Massachusetts General Hospital
sjrussell@mgh.harvard.edu
6177261848

Study Officials

  • Steven J Russell, M.D., Ph.D.

    Massachusetts General Hospital

    STUDY DIRECTOR

  • Edward Damiano, Ph.D.

    Boston University

    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
Associate Professor of Biomedical Engineering

Study Record Dates

First Submitted

May 29, 2008

First Posted

December 18, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 25, 2017

Results First Posted

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

Locations

US(1)