Clinical trial NCT00315939: Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes
Official title: Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes
hypoglycemic episodes
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2006-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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)

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 1 year (each level lasted 3 months)
measure: Frequency of Severe Hypoglycemia
timeFrame: 1 year (each level lasted 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
name: Boris Kovatchev, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.