Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 18, 2006
September 9, 2014
January 2006
December 2009   (final data collection date for primary outcome measure)
  • 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."
Not Provided
Complete list of historical versions of study NCT00315939 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes
Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Diabetes Mellitus, Type 1
  • 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 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.
    Interventions:
    • Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)
    • Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)
  • 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.
    Interventions:
    • Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)
    • Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)
Kovatchev BP, Mendosa P, Anderson S, Hawley JS, Ritterband LM, Gonder-Frederick L. Effect of automated bio-behavioral feedback on the control of type 1 diabetes. Diabetes Care. 2011 Feb;34(2):302-7. doi: 10.2337/dc10-1366. Epub 2011 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2009
December 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00315939
12126
No
Boris Kovatchev, PhD, University of Virginia
Boris Kovatchev, PhD
Not Provided
Principal Investigator: Boris Kovatchev, Ph.D. University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
University of Virginia
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP