Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes, hypoglycemic episodes
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.
Interventions
DEVICEIntegrated 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.
DEVICEIntegrated 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.
Sponsors
Boris Kovatchev, PhD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 1 year (each level lasted 3 months) | — |
| Frequency of Severe Hypoglycemia | 1 year (each level lasted 3 months) | Severe hypoglycemia (SH) was defined to subjects as blood glucose so low that you could not treat yourself because you were stuporous or unconscious. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| 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. | 61 |
| Total | 120 |
Baseline characteristics
| Characteristic | Experimental: Group A Order: SMBG, IBMF-1, IBMF-2 | Experimental: Group B Order: IBMF-1, IBMF-2, SMBG | Total |
|---|---|---|---|
| Age, Continuous | 40.65 years STANDARD_DEVIATION 14.84 | 37.61 years STANDARD_DEVIATION 13.78 | 39.15 years STANDARD_DEVIATION 14.35 |
| Sex: Female, Male Female | 33 Participants | 36 Participants | 69 Participants |
| Sex: Female, Male Male | 26 Participants | 25 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 117 | 0 / 107 |
| serious Total, serious adverse events | 0 / 117 | 0 / 107 |
Outcome results
Primary
Frequency of Severe Hypoglycemia
Severe hypoglycemia (SH) was defined to subjects as blood glucose so low that you could not treat yourself because you were stuporous or unconscious.
Time frame: 1 year (each level lasted 3 months)
Population: All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using dropout as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental Groups A and B | Frequency of Severe Hypoglycemia | SH Baseline | 0.09 episodes/month/person |
| Experimental Groups A and B | Frequency of Severe Hypoglycemia | SH Post-Level 1 | 0.21 episodes/month/person |
| Experimental Groups A and B | Frequency of Severe Hypoglycemia | SH Post-Level 2 | 0.15 episodes/month/person |
| Experimental Groups A and B | Frequency of Severe Hypoglycemia | SH Post-Level 3 | 0.02 episodes/month/person |
Primary
Hemoglobin A1c
Time frame: 1 year (each level lasted 3 months)
Population: All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using dropout as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Groups A and B | Hemoglobin A1c | Baseline | 7.99 percentage of glycated hemoglobin | Standard Deviation 1.48 |
| Experimental Groups A and B | Hemoglobin A1c | Post-Level 1 | 7.69 percentage of glycated hemoglobin | Standard Deviation 1.3 |
| Experimental Groups A and B | Hemoglobin A1c | Post-Level 2 | 7.69 percentage of glycated hemoglobin | Standard Deviation 1.33 |
| Experimental Groups A and B | Hemoglobin A1c | Post-Level 3 | 7.58 percentage of glycated hemoglobin | Standard Deviation 1.08 |
p-value: =0.001ANOVA