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Status:

COMPLETED

Biobehavioral Mechanisms of Glucose Variability

Lead Sponsor:

University of Virginia

Collaborating Sponsors:

DexCom, Inc.

Conditions:

Diabetes Mellitus, Type 1

Eligibility:

All Genders

21-65 years

Phase:

NA

Brief Summary

The purpose of this study is to investigate how blood sugar changes in response to insulin and what the body does to counter-act low blood sugar in people with Type 1 Diabetes Mellitus. Insulin sensit...

Detailed Description

Glucose variability (GV) in type 1 diabetes (T1DM) is increasingly viewed as a primary marker of glycemic control, responsible, along with chronic hyperglycemia reflected by HbA1c, for diabetes compli...

Eligibility Criteria

Inclusion

  • Clinical diagnosis of type 1 diabetes mellitus for ≥2 years. For an individual to be enrolled at least one criterion from each list must be met.
  • Criteria for documented hyperglycemia (at least 1 must be met):
  • Fasting Blood Glucose (BG) ≥126 mg/dL
  • 2h Oral Glucose Tolerance Test (OGTT) ≥200 mg/dL
  • Hemoglobin (HbA1c) ≥6.5%
  • BG ≥200 mg/dL with symptoms
  • History of hyperglycemia consistent with diabetes
  • Criteria for requiring insulin at diagnosis (1 must be met):
  • required insulin at diagnosis and continually thereafter
  • no insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and insulin eventually required and used continually
  • no insulin at diagnosis but continued hyperglycemia, positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and insulin eventually required and used continually
  • Use of an insulin pump for at least six months prior to the study.
  • Using a bolus calculator with pre-defined parameters for carbohydrate ratio(s), and insulin sensitivity factor(s).
  • Signed informed consent.
  • Age ≥21 and \<65 years old.
  • HbA1c ≤10% as measured with DCA 2000 or equivalent device.
  • Willingness to use lispro (Humalog) insulin for metabolic challenge admission.
  • Willingness to perform self-monitoring blood glucose (SMBG) \>4 times/day.
  • Willingness to avoid consumption of acetaminophen-containing products during the study.
  • Willingness to perform 4 days of outpatient assessment with timed, prepackaged meals and snacks, and \>7 SMBGs.

Exclusion

  • Uncontrolled arterial hypertension (resting blood pressure \>160/100 mm Hg).
  • Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥3 times the upper reference limit.
  • Impaired renal function: glomerular filtration rate (calc GFR) of \<60 ml/min/1.73 m2.
  • Diabetic ketoacidosis in the past 6 months
  • Conditions which may increase the risk of induced hypoglycemia such as:
  • uncontrolled coronary artery disease
  • stable or unstable angina
  • episode of chest pain of cardiac etiology with documented Electrocardiography changes or positive troponin levels
  • positive stress test
  • catheterization with coronary blockages \>50%
  • congestive heart failure
  • significant cardiac arrhythmia
  • history of a cerebrovascular event
  • seizure disorder
  • syncope
  • adrenal insufficiency
  • hypoglycemia-induced migraine within the past year
  • neurological disease
  • Diabetic complications altering insulin kinetics or food absorption
  • Pregnancy, breast-feeding or intention of becoming pregnant.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment).
  • skin condition that prevents sensor placement on the abdomen or arm.
  • Difficulties to operate Continuous Glucose Monitor.
  • Uncontrolled thyroid disease: thyroid-stimulating hormone (TSH)\>10.
  • Bleeding diathesis or dyscrasia.
  • Alcohol or drug abuse within 1 year of enrollment by patient history.
  • Allergy to components of the CGM sensor.
  • Blood donation \>473 ml in last 56 days
  • Prior noncompliance with study procedures.
  • Hematocrit outside of the normal range.
  • Magnesium \<1.6 mg/dl.
  • Potassium \<3.4 mmol/L.
  • Active enrollment in another clinical trial
  • Allergy to or intolerance of insulin lispro (Humalog)
  • Anticoagulant therapy other than aspirin.
  • Oral steroids.
  • Use of acetaminophen-containing medication that cannot be.
  • Use of Type 2 Diabetes Mellitus medications: including metformin, sulfonylureas, meglitinides, thiazolidinediones, Dipeptidyl peptidase-4 (DPP-IV) inhibitors, glucagonlike Peptide (GLP-1) agonists and alpha-glucosidase inhibitors.
  • Unwillingness to withhold Pramlintide for the duration of the study intervention.

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2014

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT01835964

Start Date

April 1 2013

End Date

February 1 2014

Last Update

July 7 2023

Active Locations (1)

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University of Virginia

Charlottesville, Virginia, United States, 22904