Type 1 DiabetesNCT00142922
Breaking Down Barriers to Diabetes Self-Care
A study testing Breaking Down Barriers in people with Type 1 Diabetes and Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Performance of self-care recommendations is key to the successful treatment of diabetes. However, many patients have difficulty adhering to diabetes self-care recommendations. Recent results from our own studies and others have identified specific barriers to diabetes self-care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Breaking Down Barriers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Patients With Type 1 Diabetes
- Aged 18-65
- Presence of type 1 diabetes mellitus.
- 2-25 year duration.
- For Patients With Type 2 Diabetes
- Aged 25-65 years
- presence of type 2 diabetes mellitus.
- 2 years since initial diagnosis.
Who cannot join
- Renal disease, microalbumin >300 ug/mg)
- Severe peripheral diabetic neuropathy and/or severe peripheral vascular disease
- Symptomatic severe autonomic neuropathy who may be at risk when increasing activity levels.
- Women who are currently pregnant
- proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included.
- HbA1c levels less than 7.0% (normal range 4.0 - 6.0%).
Show all 12Show fewer
- HbA1c levels greater than 14.0%
- patients who underwent intensive insulin treatment within one year
- a history of severe, unstable myocardial infarction, congestive heart failure or other severe cardiac disease, severe hypertension (systolic more than 160 mmHg or diastolic 90 mmHg) who may be at risk when mildly increasing physical activity
- a DSMIV diagnosis of eating disorders including anorexia nervosa, bulimia, and severe weight-related insulin omission.
- Patients with recent diagnosis (past 6 months) of bipolar disorder, schizophrenia, mental retardation, organic mental disorder, and alcohol or drug abuse
- Patients whose diabetes diagnosed cannot be clearly classified as type 1 or type 2.
Trial locations and contacts
1 site in 1 country.
About this study
Performance of self-care recommendations is key to the successful treatment of diabetes. However, many patients have difficulty adhering to diabetes self-care recommendations. Recent results from our own studies and others have identified specific barriers to diabetes self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the Breaking Down Barriers Program, that addresses barriers and therefore leads to improved adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111 type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program, 2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We hypothesize that those assigned to the Breaking Down Barriers group will improve self-care behaviors and glycemic control more than those in the two control groups. We will follow study subjects for one year to determine whether their self-care behaviors and glycemic control improved and if the improvement was maintained over time.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Breaking Down Barriers
- Keywords
- Adherence, self-care, Behavioral intervention, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breaking Down BarriersBehavioural
completed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Attended Breaking Down Barriers program Receives: Behavioral: Breaking Down Barriers |
| 2 | Active comparator | Attention control group Receives: Behavioral: Breaking Down Barriers |
| 3 | Active comparator | Indivdual attention control group Receives: Behavioral: Breaking Down Barriers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care Behaviors
Glycemic control (HbA1c)
fitness
Secondary outcomes (2)
Quality of life
Diabetes Related emaitonal distress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startOct 2002
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Katie Weinger, EdD, Principal investigator, Joslin Diabetes Center/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142922
- Sponsor's protocol ID
- DK 60115 (completed)
- Other IDs
- DK 60115, CHS00-34
- Status last verified
- Mar 2010
- First submitted
- 31 Aug 2005
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weinger K, Beverly EA, Lee Y, Sitnokov L, Ganda OP, Caballero AE. The effect of a structured behavioral intervention on poorly controlled diabetes: a randomized controlled trial. Arch Intern Med. 2011 Dec 12;171(22):1990-9. doi: 10.1001/archinternmed.2011.502. Epub 2011 Oct 10.
PubMed 21986346
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Down Barriers to Diabetes Self-Care
- ClinicalTrials.gov ID
- NCT00142922
- Acronym / sponsor ID
- DK 60115 (completed)
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Adherence, self-care, Behavioral intervention, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Oct 2002
- Study completion
- Oct 2007
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Performance of self-care recommendations is key to the successful treatment of diabetes. However, many patients have difficulty adhering to diabetes self-care recommendations. Recent results from our own studies and others have identified specific barriers to diabetes self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the Breaking Down Barriers Program, that addresses barriers and therefore leads to improved adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111 type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program, 2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We hypothesize that those assigned to the Breaking Down Barriers group will improve self-care behaviors and glycemic control more than those in the two control groups. We will follow study subjects for one year to determine whether their self-care behaviors and glycemic control improved and if the improvement was maintained over time.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Breaking Down BarriersAttended Breaking Down Barriers program |
| 2 | Active comparator | Behavioral: Breaking Down BarriersAttention control group |
| 3 | Active comparator | Behavioral: Breaking Down BarriersIndivdual attention control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- For Patients With Type 1 Diabetes
- Aged 18-65
- Presence of type 1 diabetes mellitus.
- 2-25 year duration.
- For Patients With Type 2 Diabetes
Key exclusion criteria (12 listed)
- Renal disease, microalbumin >300 ug/mg)
- Severe peripheral diabetic neuropathy and/or severe peripheral vascular disease
- Symptomatic severe autonomic neuropathy who may be at risk when increasing activity levels.
- Women who are currently pregnant
- proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included.
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 |
|---|---|---|
| Breaking Down Barrierscompleted | Behavioural | 1, 2, 3 |
Primary outcome
Self-Care Behaviors
Glycemic control (HbA1c)
fitness
2 secondary outcomes
Quality of life
Diabetes Related emaitonal distress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Derived from this study: PubMed 21986346Weinger K, Beverly EA, Lee Y, Sitnokov L, Ganda OP, Caballero AE. The effect of a structured behavioral intervention on poorly controlled diabetes: a randomized controlled trial. Arch Intern Med. 2011 Dec 12;171(22):1990-9. doi: 10.1001/archinternmed.2011.502. Epub 2011 Oct 10.
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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.
Katie Weinger, EdD principal investigator
Joslin Diabetes Center/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breaking Down Barriers in people with Type 1 Diabetes and Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 8 inclusion and 12 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 2 Mar 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-Care Behaviors. The study lists 3 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 NCT00142922, 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 2 Mar 2010.