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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Closed-loop Glucose Control for Automated Management of Type 1 Diabetes

NCTNCT00811317 (opens ClinicalTrials.gov in a new tab)Other id2007P-000101Other idH-27207Other idSPID#0813

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
11 participants (actual)
Sponsor
Boston University Charles River Campus · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
May 2008
Primary completion
Oct 2009
Completion
Oct 2009
First posted
18 Dec 2008 (estimated)
Last update posted
25 Oct 2017
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010
  1. N/A

    Closed-loop Glucose Control for Automated Management of Type 1 Diabetes

    NCT00811317

    May 2008 to Oct 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Closed-loopDevice

Arms1

  • Experimental

    Closed-loop

    Type 1 diabetic subjects under closed-loop blood glucose control

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Average Blood Glucose Over the Closed-loop Control Period

    Time frame · 24 hours

Secondary outcomes(20)
  1. Percentage of Time Spent Within 70-180 mg/dl

    Time frame · 24 hours

  2. Peak Hyperglycemia Following Each Meal

    Time frame · After each of 3 meals

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

    Time frame · After each of 3 meals

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

    Time frame · 24 hours

  5. Percentage of Time Spent With BG < 70 mg/dl

    Time frame · 24 hours

  6. Number of Hypoglycemic Events

    Time frame · 24 hours

    Registry description

    This outcome captures the number of hypoglycemic events that occurred throughout the entire study

  7. Nadir Blood Glucose Level for Each Hypoglycemic Event

    Time frame · 24 hours

  8. Percentage of Time Spent With BG > 180 mg/dl

    Time frame · 24 hours

  9. Total Insulin Dose

    Time frame · 24 hours

  10. Glucagon T-max

    Time frame · 24 hours

    Registry description

    Time to maximum peak glucagon concentration

  11. Total Glucagon Dose

    Time frame · 24 hours

  12. Blood Glucagon Levels

    Time frame · 24 hours

  13. Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data

    Time frame · 24 hours

  14. Number of Carbohydrate Interventions

    Time frame · 24 hours

  15. Number of Participants Achieving a Stable Glucose Response to Insulin Dosing

    Time frame · 24 hours

  16. Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals

    Time frame · 24 hours

  17. Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard

    Time frame · 24 hours

    Registry description

    Measuring the mean absolute relative difference (MARD) between the blood glucose measurement and CGM glucose readings, on three different CGM devices: Dexcom, Guardian and Navigator

  18. Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects

    Time frame · 24 hours

  19. Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects

    Time frame · 24 hours

  20. Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard

    Time frame · 24 hours

    Registry description

    Mean absolute relative difference (MARD) of CGM and BG glucose readings in hypoglycemia (\< 70 mg/dl) and hyperglycemia (\>180 mg/dl) in three different CGM devices: Dexcom, Navigator and Guardian

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 24 hours

Average Blood Glucose Over the Closed-loop Control Period

GroupValue (mg/dl)Spread
Closed-loop16417
Secondary and other outcome results(7)
Secondary outcomeMean· 24 hours

Percentage of Time Spent Within 70-180 mg/dl

GroupValue (percentage of time)Spread
Closed-loop6115
Secondary outcomeMean· After each of 3 meals

Peak Hyperglycemia Following Each Meal

GroupValue (mg/dl)Spread
Closed-loop226.726.6
Secondary outcomeMean· After each of 3 meals

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

GroupValue (percentage of time)Spread
Closed-loop389
Secondary outcomeNumber· 24 hours

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

GroupValue (percentage of blood glucose measurements)
Closed-loop6
Secondary outcomeMean· 24 hours

Percentage of Time Spent With BG < 70 mg/dl

GroupValue (percentage of time)Spread
Closed-loop0.350.33
Secondary outcomeNumber· 24 hours

Number of Hypoglycemic Events

GroupValue (Number of events)
Closed-loop2
Secondary outcomeNumber· 24 hours

Nadir Blood Glucose Level for Each Hypoglycemic Event

GroupValue (mg/dl)
Closed-loop66

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Closed-loopType 1 diabetic subjects under closed-loop blood glucose control Closed-loop: 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 target0 / 110 / 110 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2007

Adaptive closed-loop control provides blood-glucose regulation using dual subcutaneous insulin and glucagon infusion in diabetic Swine.

El-Khatib et al. 2007Journal of diabetes science and technologycited by 52

PMID 19888405PMC2771467DOI 10.1177/193229680700100208PUB-19888405

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria (type 1 diabetic subjects): * 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 Inclusion Criteria (non-diabetic subjects): * 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 * Normal 75 g oral glucose tolerance test (fasting, 1 hour, and 2 hour measurements) Exclusion Criteria (all subjects): * 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 * History of pheochromocytoma * Abnormal plasma fractionated metanephrines * History of adrenal disease or tumor * History of pancreatic tumor, including insulinoma * History of impaired gastric motility or gastroparesis requiring pharmacological or surgical treatment * Current alcohol abuse (\> 3 drinks daily) or substance abuse (any use within the last 6 months of illegal drugs) * Severe mental illness (schizophrenia, bipolar disease, inadequately treated depression, or any psychiatric hospitalization in the last year) * Impaired cognition or altered mental status. * Hypertension (blood pressure \> 140/90) at the time of screening * Use of medications that reduce gastric motility * Electrically powered implants that might be susceptible to RF interference * Use non-insulin injectable anti-diabetic medications, inhaled insulin, or oral anti-diabetic medications * History of adverse reaction to glucagon (including allergy) besides nausea and vomiting. * Established history of latex, adhesive, tape allergy, inadequate venous access, history of allergy to or intolerance of aspirin.

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