Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315939
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2006-04-18
Brief Title:
Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes
Sponsor:
Boris Kovatchev PhD
Organization:
University of Virginia
Study Overview
Official Title:
Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BPK002
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None