Type1diabetesNCT03039933
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
A study testing Fear of Hypoglycemia and Treatment As Usual in people with Type1diabetes and Fear of Hypoglycemia, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type1diabetes, Fear of Hypoglycemia
- What is being tested?
- Fear of Hypoglycemia and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2020
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- adolescents aged 10-17 years and their parent(s) or legal guardian;
- T1D duration >1 year;
- insulin pump use >6 months;
- agreement of both parent and adolescent to participate in intervention sessions;
- elevated scores on the Parent Hypoglycemia Fear Survey - Behavior Subscale.
Who cannot join
- developmental disability or reading disorder that prevents understanding of the intervention materials; and
- non-English speaking adolescents and parents.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Denver
Aurora, Colorado, 80045
About this study
The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in adolescents with Type 1 Diabetes (T1D) and their parents.
- Conditions
- Type1diabetes, Fear of Hypoglycemia
- Being tested
- Fear of Hypoglycemia, Treatment As Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear of HypoglycemiaBehavioural
Participants will receive exposure and response prevention and/or hypoglycemia awareness training.
Treatment As UsualOther
Also called Standard of Care
Treatment As Usual
| Study group | Role | What they receive |
|---|---|---|
| Fear of Hypoglycemia Intervention | Active comparator | Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks. Receives: Behavioral: Fear of Hypoglycemia |
| Treatment As Usual | Other | Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in scores on the Hypoglycemia Fear Survey
To address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by evaluating the efficacy of Blood Glucose Awareness Training as compared to treatment as usual.
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startAug 2016
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Kimberly Driscoll, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039933
- Sponsor's protocol ID
- 16-0645
- Status last verified
- Sep 2021
- First submitted
- 19 Dec 2016
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
- ClinicalTrials.gov ID
- NCT03039933
- Acronym / sponsor ID
- 16-0645
- Conditions
- Type1diabetes, Fear of Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Virginia
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 1 Feb 2017 (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.
The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03) is to address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in adolescents with Type 1 Diabetes (T1D) and their parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fear of Hypoglycemia Intervention | Active comparator | Behavioral: Fear of HypoglycemiaCognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks. |
| Treatment As Usual | Other | Other: Treatment As UsualControl group completes questionnaires but does not receive any study intervention. Receives medical care as usual. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- adolescents aged 10-17 years and their parent(s) or legal guardian;
- T1D duration >1 year;
- insulin pump use >6 months;
- agreement of both parent and adolescent to participate in intervention sessions;
- elevated scores on the Parent Hypoglycemia Fear Survey - Behavior Subscale.
Key exclusion criteria (2 listed)
- developmental disability or reading disorder that prevents understanding of the intervention materials; and
- non-English speaking adolescents and parents.
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 |
|---|---|---|
| Fear of HypoglycemiaParticipants will receive exposure and response prevention and/or hypoglycemia awareness training. | Behavioural | Fear of Hypoglycemia Intervention |
| Treatment As UsualAlso: Standard of CareTreatment As Usual | Other | Treatment As Usual |
Primary outcome
Decrease in scores on the Hypoglycemia Fear Survey
Time frame: Baseline, 3 and 6 months
To address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by evaluating the efficacy of Blood Glucose Awareness Training as compared to treatment as usual.
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 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Kimberly Driscoll, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fear of Hypoglycemia and Treatment As Usual in people with Type1diabetes and Fear of Hypoglycemia, run by University of Colorado, Denver 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 5 inclusion and 2 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 16 Sep 2021. 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?
Decrease in scores on the Hypoglycemia Fear Survey (time frame: Baseline, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.