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
Results First Received: August 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Diabetes Mellitus, Type 1
Interventions: Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)
Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 120 adults with type 1 diabetes were recruited through regional advertising. Inclusion criteria were age ≥18 years, type 1 diabetes defined by the American Diabetes Association criteria or physician judgment, and willingness to participate in the study for up to 12 months performing finger sticks four to five times per day.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Experimental: Group A Order: SMBG, IBMF-1, IBMF-2 Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. 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, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. 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.
Experimental: Group B Order: IBMF-1, IBMF-2, SMBG Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. 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, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. 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.

Participant Flow for 3 periods

Period 1:   Admission 1 (3 Months)
    Experimental: Group A Order: SMBG, IBMF-1, IBMF-2     Experimental: Group B Order: IBMF-1, IBMF-2, SMBG  
STARTED     59     61  
COMPLETED     56     55  
NOT COMPLETED     3     6  

Period 2:   Admission 2 (3 Months)
    Experimental: Group A Order: SMBG, IBMF-1, IBMF-2     Experimental: Group B Order: IBMF-1, IBMF-2, SMBG  
STARTED     56     55  
COMPLETED     52     51  
NOT COMPLETED     4     4  

Period 3:   Admission 3 (3 Months)
    Experimental: Group A Order: SMBG, IBMF-1, IBMF-2     Experimental: Group B Order: IBMF-1, IBMF-2, SMBG  
STARTED     52     51  
COMPLETED     48     49  
NOT COMPLETED     4     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Experimental: Group A Order: SMBG, IBMF-1, IBMF-2 Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months.
Experimental: Group B Order: IBMF-1, IBMF-2, SMBG Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months.
Total Total of all reporting groups

Baseline Measures
    Experimental: Group A Order: SMBG, IBMF-1, IBMF-2     Experimental: Group B Order: IBMF-1, IBMF-2, SMBG     Total  
Number of Participants  
[units: participants]
  59     61     120  
Age  
[units: years]
Mean ± Standard Deviation
  40.65  ± 14.84     37.61  ± 13.78     39.15  ± 14.35  
Gender  
[units: participants]
     
Female     33     36     69  
Male     26     25     51  



  Outcome Measures
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1.  Primary:   Hemoglobin A1c   [ Time Frame: 1 year (each level lasted 3 months) ]

2.  Primary:   Frequency of Severe Hypoglycemia   [ Time Frame: 1 year (each level lasted 3 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Boris Kovatchev, PhD
Organization: University of Virginia
phone: 434-924-5592
e-mail: bpk2u@virginia.edu


Publications:

Responsible Party: Boris Kovatchev, PhD, 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