Diabetes Mellitus, Type 1NCT03809858
Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
A study testing Klue App in people with Diabetes Mellitus, Type 1, run by University of Virginia at 1 site in United States.
Trial summary
This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Klue App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 18 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and over
- Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
- Willing to wear a CGM at least 70% of the time while in the study
- Willing to wear an Apple watch on their dominant hand while awake
- Missing or late in giving at least four food boluses in the previous 2 weeks
- Understanding and willingness to follow the protocol and sign informed consent
Who cannot join
- Pregnant or lactating women
- A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
- Current treatment for a seizure disorder
- Inpatient psychiatric treatment in the past 6 months
- Subject may participate in another trial if it is approved by the investigators of both trials.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Klue App
- Keywords
- Klue, Meal bolus, Bolus reminder
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Klue AppOther
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
| Study group | Role | What they receive |
|---|---|---|
| Klue App Use then Usual Care | Experimental | Subjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product. Receives: Other: Klue App |
| Usual Care then Klue App Use | Experimental | Subjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product. Receives: Other: Klue App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of missed meal boluses
The change in the number of missed meal boluses
Measured: During the two weeks prior to each visit
Secondary outcomes (21)
Number of missed meal boluses as a measure of attenuation to the alerts
The change in the number of missed meal boluses as a measure of attenuation to the alerts
Measured: 6 weeks
Number of missed meal boluses as a measure of attenuation to the alerts
The change in the number of missed meal boluses as a measure of attenuation to the alerts
Measured: 12 weeks
Change in Hemoglobin A1c Levels
Change in Hemoglobin A1c Levels
Measured: 3 months
Time in range 70-180 mg/dL
Time in range 70-180 mg/dL as measured by CGM
Measured: 6 weeks
Time in range 70-180 mg/dL
Time in range 70-180 mg/dL as measured by CGM
Measured: 12 weeks
Percent time <70 mg/dL mean glucose
Percent time <70 mg/dL mean glucose as measured by CGM
Measured: 6 weeks
Percent time <70 mg/dL mean glucose
Percent time <70 mg/dL mean glucose as measured by CGM
Measured: 12 weeks
Glucose Coefficient of Variation
Glucose (as measured by CGM) Coefficient of Variation
Measured: 6 weeks
Glucose Coefficient of Variation
Glucose (as measured by CGM) Coefficient of Variation
Measured: 12 weeks
Total daily insulin dose
Total daily insulin dose
Measured: 6 weeks
Total daily insulin dose
Total daily insulin dose
Measured: 12 weeks
Number of meal bolus injections each day
Number of meal bolus injections each day
Measured: 6 weeks
Number of meal bolus injections each day
Number of meal bolus injections each day
Measured: 12 weeks
Number of total bolus injections each day
Number of total bolus injections each day
Measured: 6 weeks
Number of total bolus injections each day
Number of total bolus injections each day
Measured: 12 weeks
Total daily basal insulin
Total daily basal insulin
Measured: 6 weeks
Total daily basal insulin
Total daily basal insulin
Measured: 12 weeks
Accuracy of Klue in detecting meals
Accuracy of Klue in detecting meals (true positive and false positive rates)
Measured: 3 months
User satisfaction of Klue
User satisfaction of Klue
Measured: 3 months
Diabetes-Specific Attitudes about Technology (DSAT) Scores
DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)
Measured: 3 months
Diabetes Distress Scale (DDS) Scores
DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start29 May 2019
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized to the sequence of completion in a 1:1 ratio. All subject will collect data throughout the study with half of them using the Klue App during the first 6 weeks and half using the Klue App during the second 6 weeks.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Klue, Inc.
- Responsible party
- Principal investigator, Marc Breton, University of Virginia
- Investigators
- Marc Breton, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809858
- Sponsor's protocol ID
- 180034
- Status last verified
- Apr 2020
- First submitted
- 11 Jan 2019
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data
Publications
Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ. Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics. 2004 Mar;113(3 Pt 1):e221-4. doi: 10.1542/peds.113.3.e221.
PubMed 14993580Olinder AL, Kernell A, Smide B. Missed bolus doses: devastating for metabolic control in CSII-treated adolescents with type 1 diabetes. Pediatr Diabetes. 2009 Apr;10(2):142-8. doi: 10.1111/j.1399-5448.2008.00462.x. Epub 2008 Oct 24.
PubMed 19175898O'Connell MA, Donath S, Cameron FJ. Poor adherence to integral daily tasks limits the efficacy of CSII in youth. Pediatr Diabetes. 2011 Sep;12(6):556-9. doi: 10.1111/j.1399-5448.2010.00740.x. Epub 2011 Apr 6.
PubMed 21466646Naranjo D, Tanenbaum ML, Iturralde E, Hood KK. Diabetes Technology: Uptake, Outcomes, Barriers, and the Intersection With Distress. J Diabetes Sci Technol. 2016 Jun 28;10(4):852-8. doi: 10.1177/1932296816650900. Print 2016 Jul.
PubMed 27234809
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
- ClinicalTrials.gov ID
- NCT03809858
- Acronym / sponsor ID
- 180034
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Klue, Meal bolus, Bolus reminder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Stanford University, Klue, Inc.
- Study start
- 29 May 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- 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.
This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to the sequence of completion in a 1:1 ratio. All subject will collect data throughout the study with half of them using the Klue App during the first 6 weeks and half using the Klue App during the second 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Klue App Use then Usual Care | Experimental | Other: Klue AppSubjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product. |
| Usual Care then Klue App Use | Experimental | Other: Klue AppSubjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 and over
- Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
- Willing to wear a CGM at least 70% of the time while in the study
- Willing to wear an Apple watch on their dominant hand while awake
- Missing or late in giving at least four food boluses in the previous 2 weeks
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
- Current treatment for a seizure disorder
- Inpatient psychiatric treatment in the past 6 months
- Subject may participate in another trial if it is approved by the investigators of both trials.
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 |
|---|---|---|
| Klue AppThe Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so. | Other | Klue App Use then Usual Care, Usual Care then Klue App Use |
Primary outcome
Number of missed meal boluses
Time frame: During the two weeks prior to each visit
The change in the number of missed meal boluses
21 secondary outcomes
Number of missed meal boluses as a measure of attenuation to the alerts
Time frame: 6 weeks
Number of missed meal boluses as a measure of attenuation to the alerts
Time frame: 12 weeks
Change in Hemoglobin A1c Levels
Time frame: 3 months
Time in range 70-180 mg/dL
Time frame: 6 weeks
Time in range 70-180 mg/dL
Time frame: 12 weeks
Percent time <70 mg/dL mean glucose
Time frame: 6 weeks
Percent time <70 mg/dL mean glucose
Time frame: 12 weeks
Glucose Coefficient of Variation
Time frame: 6 weeks
Glucose Coefficient of Variation
Time frame: 12 weeks
Total daily insulin dose
Time frame: 6 weeks
Total daily insulin dose
Time frame: 12 weeks
Number of meal bolus injections each day
Time frame: 6 weeks
Number of meal bolus injections each day
Time frame: 12 weeks
Number of total bolus injections each day
Time frame: 6 weeks
Number of total bolus injections each day
Time frame: 12 weeks
Total daily basal insulin
Time frame: 6 weeks
Total daily basal insulin
Time frame: 12 weeks
Accuracy of Klue in detecting meals
Time frame: 3 months
User satisfaction of Klue
Time frame: 3 months
Diabetes-Specific Attitudes about Technology (DSAT) Scores
Time frame: 3 months
Diabetes Distress Scale (DDS) Scores
Time frame: 3 months
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 21 Apr 2020.
- Background: PubMed 14993580Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ. Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics. 2004 Mar;113(3 Pt 1):e221-4. doi: 10.1542/peds.113.3.e221.
- Background: PubMed 19175898Olinder AL, Kernell A, Smide B. Missed bolus doses: devastating for metabolic control in CSII-treated adolescents with type 1 diabetes. Pediatr Diabetes. 2009 Apr;10(2):142-8. doi: 10.1111/j.1399-5448.2008.00462.x. Epub 2008 Oct 24.
- Background: PubMed 21466646O'Connell MA, Donath S, Cameron FJ. Poor adherence to integral daily tasks limits the efficacy of CSII in youth. Pediatr Diabetes. 2011 Sep;12(6):556-9. doi: 10.1111/j.1399-5448.2010.00740.x. Epub 2011 Apr 6.
- Background: PubMed 27234809Naranjo D, Tanenbaum ML, Iturralde E, Hood KK. Diabetes Technology: Uptake, Outcomes, Barriers, and the Intersection With Distress. J Diabetes Sci Technol. 2016 Jun 28;10(4):852-8. doi: 10.1177/1932296816650900. Print 2016 Jul.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data
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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.
Marc Breton, PhD 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?
A study testing Klue App in people with Diabetes Mellitus, Type 1, 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 5 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 21 Apr 2020. 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?
Number of missed meal boluses (time frame: During the two weeks prior to each visit). 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 NCT03809858, which also lists 4 linked publications.
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 21 Apr 2020.