Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback

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

Sponsors

Lead sponsor: Boris Kovatchev, PhD

Source University of Virginia
Brief Summary

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.

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.

Overall Status Completed
Start Date January 2006
Completion Date December 2009
Primary Completion Date December 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin A1c 1 year (each level lasted 3 months)
Frequency of Severe Hypoglycemia 1 year (each level lasted 3 months)
Enrollment 120
Condition
Intervention

Intervention type: Device

Intervention name: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)

Description: 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.

Intervention type: Device

Intervention name: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)

Description: 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.

Eligibility

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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Boris Kovatchev, Ph.D. Principal Investigator University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
Location
facility University of Virginia
Location Countries

United States

Verification Date

August 2014

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: University of Virginia

Investigator full name: Boris Kovatchev, PhD

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group A Order: SMBG, IBMF-1, IBMF-2

Arm group type: Experimental

Description: 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.

Arm group label: Group B Order: IBMF-1, IBMF-2, SMBG

Arm group type: Experimental

Description: 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.

Acronym BPK002
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov