Type I Diabetes MellitusNCT02126605
Accuracy of Blood Glucose Detection by Diabetes Alert Dogs
An observational study of Type I Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial summary
Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed the ability of DADs to accurately detect extreme high and low blood sugar. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Type I Diabetes Mellitus
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 2015
- Phase
- Observational
- 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 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetes Alert Dog (DAD) owners who have obtained their dogs from a specific training organization.
Who may be able to join
- The participant must have had type 1 diabetes for at least 1 year and been taking insulin since diagnosis
- The participant must have a DAD placed in their home for a minimum of 6 months.
- Participants must not currently be using a continuous glucose monitor (CGM) in their diabetes management.
- Participants must be capable of performing all tasks involved in the study protocol, including filling out questionnaires and diaries in English.
- Participants must have an internet-connected computer compatible with study software.
- Willingness to avoid consumption of acetaminophen-containing products for the duration of the study.
Who cannot join
- Pregnant women-self reported
- Current use of a CGM
- History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Behavioral Medicine Research
Charlottesville, Virginia, 22908
Jesse Grabman, B.A., 434-924-5316, JHG5DQ@hscmail.mcc.virginia.edu
Linda Gonder-Frederick, Ph.D.
About this study
Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed the ability of DADs to accurately detect extreme high and low blood sugar. The current project is the first preliminary investigation into the accuracy of DADs, using scientifically rigorous research methods similar to those required to demonstrate accuracy in blood glucose meters. The primary aim of the project is to test the hypotheses that DADs are accurate at detecting extreme blood sugar levels in adults and children with T1D. The proposed project has several other secondary aims, which include determining: 1) the glycemic thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to which alert accuracy is consistent across different DADs, and 3) whether or not DAD owners appear to experience better psychosocial status and quality of life compared to other individuals with T1D.
Read the detailed description
In the proposed project, DAD alerts will be compared to blood glucose (BG) readings from a continuous glucose monitoring (CGM) device, as well as a BG meter. CGM, BG meter, and DAD alert data will be collected over a 4-wk period. CGM devices will be "blinded" so that BG readings will not be shown. This will allow for a direct comparison between objective glucose readings generated by approved BG monitoring devices and DAD alerts. This study will also utilize two methods for measuring DAD alerts: (1) use of the event recorder mechanism of the CGM device, and (2) collection of more detailed and qualitative data on DAD alerts using diaries (Daily DAD Diaries) to collect information concerning the occurrence, timing, and type of DAD alerts.
- Conditions
- Type I Diabetes Mellitus
- Keywords
- diabetes alert dogs, hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent agreement between DAD alerts and glucose readings
Measured: 5 weeks
Secondary outcomes (1)
Psychosocial variables (quality of life, fear of hypo-/hyperglycemia, diabetes distress, self-efficacy, and DAD experiences)
Measured: Baseline, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Gonder-Frederick, University of Virginia
- Investigators
- Linda Gonder-Frederick, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126605
- Sponsor's protocol ID
- 17296
- Status last verified
- Apr 2014
- First submitted
- 24 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Blood Glucose Detection by Diabetes Alert Dogs
- ClinicalTrials.gov ID
- NCT02126605
- Acronym / sponsor ID
- 17296
- Conditions
- Type I Diabetes Mellitus
- Keywords
- diabetes alert dogs, hypoglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 30 Apr 2014 (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.
Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed the ability of DADs to accurately detect extreme high and low blood sugar. The current project is the first preliminary investigation into the accuracy of DADs, using scientifically rigorous research methods similar to those required to demonstrate accuracy in blood glucose meters. The primary aim of the project is to test the hypotheses that DADs are accurate at detecting extreme blood sugar levels in adults and children with T1D. The proposed project has several other secondary aims, which include determining: 1) the glycemic thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to which alert accuracy is consistent across different DADs, and 3) whether or not DAD owners appear to experience better psychosocial status and quality of life compared to other individuals with T1D.
Detailed description
In the proposed project, DAD alerts will be compared to blood glucose (BG) readings from a continuous glucose monitoring (CGM) device, as well as a BG meter. CGM, BG meter, and DAD alert data will be collected over a 4-wk period. CGM devices will be "blinded" so that BG readings will not be shown. This will allow for a direct comparison between objective glucose readings generated by approved BG monitoring devices and DAD alerts. This study will also utilize two methods for measuring DAD alerts: (1) use of the event recorder mechanism of the CGM device, and (2) collection of more detailed and qualitative data on DAD alerts using diaries (Daily DAD Diaries) to collect information concerning the occurrence, timing, and type of DAD alerts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetes Alert Dog (DAD) owners who have obtained their dogs from a specific training organization.
Key inclusion criteria (6 listed)
- The participant must have had type 1 diabetes for at least 1 year and been taking insulin since diagnosis
- The participant must have a DAD placed in their home for a minimum of 6 months.
- Participants must not currently be using a continuous glucose monitor (CGM) in their diabetes management.
- Participants must be capable of performing all tasks involved in the study protocol, including filling out questionnaires and diaries in English.
- Participants must have an internet-connected computer compatible with study software.
Key exclusion criteria (3 listed)
- Pregnant women-self reported
- Current use of a CGM
- History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent agreement between DAD alerts and glucose readings
Time frame: 5 weeks
1 secondary outcome
Psychosocial variables (quality of life, fear of hypo-/hyperglycemia, diabetes distress, self-efficacy, and DAD experiences)
Time frame: Baseline, 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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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.
Linda Gonder-Frederick, Ph.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type I Diabetes Mellitus, run by University of Virginia 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesse Grabman, B.A. (434-924-5316, JHG5DQ@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent agreement between DAD alerts and glucose readings (time frame: 5 weeks). 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 30 Apr 2014.