Diabetes Mellitus, Type 1BPK002NCT00315939

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

A study testing Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) and Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2) in people with Diabetes Mellitus, Type 1, run by Boris Kovatchev, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) and Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Jan 2006to Dec 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia
Charlottesville, Virginia, 22903

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Diabetes Mellitus, Type 1
Being tested: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1), Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)
Keywords: Diabetes, hypoglycemic episodes
Medical subject headings: Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)Device
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.
Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)Device
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.

Study groups in NCT00315939
Study group	Role	What they receive
Group A Order: SMBG, IBMF-1, IBMF-2	Experimental	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. Receives: Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1); Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)
Group B Order: IBMF-1, IBMF-2, SMBG	Experimental	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. Receives: Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1); Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemoglobin A1c
Measured: 1 year (each level lasted 3 months)
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."
Measured: 1 year (each level lasted 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Dec 2009

First posted19 Apr 2006 (estimated)
Study startJan 2006
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00315939
Sponsor's protocol ID: 12126
Acronym: BPK002
Status last verified: Aug 2014
First submitted: 18 Apr 2006
Last updated: 18 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21216860

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback
ClinicalTrials.gov ID: NCT00315939
Acronym / sponsor ID: BPK002 / 12126
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes, hypoglycemic episodes
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Boris Kovatchev, PhDUniversity, hospital or other
Study start: Jan 2006
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 19 Apr 2006 (estimated)
Results: Posted 9 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A Order: SMBG, IBMF-1, IBMF-2	Experimental	Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1), Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)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.
Group B Order: IBMF-1, IBMF-2, SMBG	Experimental	Device: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1), Device: Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Integrated 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.	Device	Group A Order: SMBG, IBMF-1, IBMF-2, Group B Order: IBMF-1, IBMF-2, SMBG
Integrated 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.	Device	Group A Order: SMBG, IBMF-1, IBMF-2, Group B Order: IBMF-1, IBMF-2, SMBG

Primary outcome

Hemoglobin A1c
Time frame: 1 year (each level lasted 3 months)
Frequency of Severe Hypoglycemia
Time frame: 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."

Results and safety

Results posted to the registry on 9 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Group A Order: SMBG, IBMF-1, IBMF-2	59	56
Experimental: Group B Order: IBMF-1, IBMF-2, SMBG	61	55

Primary outcome: Hemoglobin A1c

Time frame: 1 year (each level lasted 3 months). Mean (Standard Deviation). Unit: percentage of glycated hemoglobin

Measure	Experimental Groups A and B n = 97
Baseline	7.99 (1.48)
Post-Level 1	7.69 (1.30)
Post-Level 2	7.69 (1.33)
Post-Level 3	7.58 (1.08)

Experimental Groups A and B: p =0.001, ANOVA

Population analysed: 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.

Primary outcome: Frequency of Severe Hypoglycemia

Time frame: 1 year (each level lasted 3 months). Number. Unit: episodes/month/person

Measure	Experimental Groups A and B n = 97
SH Baseline	0.09
SH Post-Level 1	0.21
SH Post-Level 2	0.15
SH Post-Level 3	0.02

Adverse events

Time frame: January 2006 - December 2009. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IBMF-1	0 of 117 (0%)	0 of 117 (0%)	Not reported
IBMF-2	0 of 107 (0%)	0 of 107 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21216860Kovatchev 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boris Kovatchev, Ph.D. principal investigator

University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c (time frame: 1 year (each level lasted 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00315939, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.