Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes (BPK002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00315939
First received: April 18, 2006
Last updated: September 9, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to test two newly developed computer programs, Integrated Biobehavioral Monitoring and Feedback (IBMF) IBMF-1 and IBMF-2. The computer programs are considered experimental. Both computer programs are being tested to see if they are useful in helping people with type 1 diabetes avoid low blood sugar episodes.


Condition Intervention
Diabetes Mellitus, Type 1
Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)
Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 1 year (each level lasted 3 months) ] [ Designated as safety issue: No ]
  • Frequency of Severe Hypoglycemia [ Time Frame: 1 year (each level lasted 3 months) ] [ Designated as safety issue: No ]
    Severe hypoglycemia (SH) was defined to subjects as "blood glucose so low that you could not treat yourself because you were stuporous or unconscious."


Enrollment: 120
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Order: SMBG, IBMF-1, IBMF-2
Group A performed routine self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2) level 3. Each level continued for 3 months.
Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)
Integrated Biobehavioral Monitoring & Feedback-1 (IBMF-1): a hand-held computer (HHC) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia (Low BG Index), and glucose variability (Average Daily Risk Range) using previously published algorithms. The subjects were asked to carry the HHC and enter all their self-monitored blood glucose (SMBG) readings. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. Detailed instructions were provided on the meaning of these different types of glucose feedback; the study staff was available to answer any questions.
Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)
Integrated Biobehavioral Monitoring & Feedback-2 (IMBF-2) retains IMBF-1, but the HHC asked subjects to provide symptom ratings when blood glucose (BG) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. The patient manual for the HHC program is provided in supplementary data of published manuscript.
Experimental: Group B Order: IBMF-1, IBMF-2, SMBG
Group B began with Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2, followed by level 3, Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2) and then level 1 (SMBG only). Each level continued for 3 months.
Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)
Integrated Biobehavioral Monitoring & Feedback-1 (IBMF-1): a hand-held computer (HHC) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia (Low BG Index), and glucose variability (Average Daily Risk Range) using previously published algorithms. The subjects were asked to carry the HHC and enter all their self-monitored blood glucose (SMBG) readings. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. Detailed instructions were provided on the meaning of these different types of glucose feedback; the study staff was available to answer any questions.
Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)
Integrated Biobehavioral Monitoring & Feedback-2 (IMBF-2) retains IMBF-1, but the HHC asked subjects to provide symptom ratings when blood glucose (BG) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. The patient manual for the HHC program is provided in supplementary data of published manuscript.

Detailed Description:

Subjects were randomized into group A or group B matched by gender, age, and baseline HbA1c. Group A began with routine self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by IBMF-1 (level 2) and IBMF-2 (level 3). Group B began with level 2, followed by level 3 and then level 1.

Each level continued for 3 months and proceeded as follows: level 1 was routine SMBG. Subjects were given LifeScan OneTouch UltraSmart meters (LifeScan Inc., Milpitas, CA) and free strips, and asked to perform SMBG four to five times per day. No additional instructions about the timing of SMBG or the interpretation of the data were given. No changes to treatment were recommended. At each visit, the subject was only asked about any health concerns or any new medications or change in insulin. This information was recorded but not used for feedback. Thus, level 1 should be regarded as a control condition, which was different from routine SMBG only because subjects were enrolled in a study and given free test strips.

IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia (Low BG Index, LBGI), and glucose variability (Average Daily Risk Range, ADRR) using previously published algorithms. The subjects were asked to carry the HHC and enter all their glucose readings when per- forming SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. Detailed instructions were provided on the meaning of these different types of glucose feedback; the study staff was available to answer any questions.

IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. The patient manual for the HHC program is provided in supplementary data of published manuscript.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Have type 1 diabetes as defined by the American Diabetes Association or by the judgment of the physician
  • Willing to participate for up to one year
  • Perform routine blood glucose checks 3-4 times a day
  • Complete monthly diaries of the occurrence of severe and moderate hypoglycemic episodes
  • Have 6 hemoglobin A1c (HgbA1c) drawn
  • Have a mixed meal tolerance test to assess for residual pancreatic insulin secretion

Exclusion Criteria:

  • Age < 18 years
  • Currently abusing alcohol or drugs
  • Severe depression or psychosis
  • Significant mental impairment
  • Inability to use a glucometer and a hand held computer
  • Pregnant or desire to achieve pregnancy within the following year (females)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315939

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Boris Kovatchev, PhD
Investigators
Principal Investigator: Boris Kovatchev, Ph.D. University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
  More Information

Publications:
Responsible Party: Boris Kovatchev, PhD, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT00315939     History of Changes
Other Study ID Numbers: 12126
Study First Received: April 18, 2006
Results First Received: August 8, 2014
Last Updated: September 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Diabetes
hypoglycemic episodes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014