Type1 Diabetes MellitusKlueNCT03970889
Real-time Reminders To Decrease Late or Missed Meal Boluses
A study testing Klue in people with Type1 Diabetes Mellitus, run by Stanford University at 1 site in United States.
Trial summary
This study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Klue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2018to 30 Mar 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 13 and over
- On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM
- Willing to wear a CGM at least 70% of the time while in the study
- Using an iPhone
- 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 two weeks
- Understanding and willingness to follow the protocol and sign informed consent
- Ability to speak, read and write in the language of the investigators
Who cannot join
- Pregnant or lactating
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- Current treatment for a seizure disorder
- Inpatient psychiatric treatment in the past 6 months
- Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment. They may be participating in another trial, if this study is approved by the investigators of the other trial.
Trial locations and contacts
1 site in 1 country.
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 study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit. If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.
Read the detailed description
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) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. The investigators do not have 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
- Type1 Diabetes Mellitus
- Being tested
- Klue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KlueDevice
Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory |
| Klue | Experimental | Subjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software. Receives: Device: Klue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of missed meal boluses
A missed meal bolus is defined by no insulin dose within 2 hours from the start of the CGM rise.
Measured: The two weeks prior to each study visit
Secondary outcomes (2)
Change in time in range
sensor glucose values between 70-180 mg/dl
Measured: data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject
Positive predictive value of a Klue meal alert
Percent of time a meal alert signaled a meal
Measured: All data for the 6 weeks on the Klue intervention arm when Klue is active
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start12 Oct 2018
- Primary completion19 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 are randomized so that half will use the Klue App in the first 6 weeks of the study, and half will use the Klue App during the second 6 weeks of the study.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Buckingham, Stanford University
- Investigators
- Bruce Buckingham, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970889
- Sponsor's protocol ID
- 47137
- Acronym
- Klue
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2018
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19175898
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. 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
- NCT03970889
- Acronym / sponsor ID
- Klue / 47137
- Conditions
- Type1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 3 Jun 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 study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit. If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.
Detailed description
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) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. The investigators do not have 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 are randomized so that half will use the Klue App in the first 6 weeks of the study, and half will use the Klue App during the second 6 weeks of the study.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory |
| Klue | Experimental | Device: KlueSubjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age 13 and over
- On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM
- Willing to wear a CGM at least 70% of the time while in the study
- Using an iPhone
- Willing to wear an Apple watch on their dominant hand while awake
Key exclusion criteria (5 listed)
- Pregnant or lactating
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- Current treatment for a seizure disorder
- Inpatient psychiatric treatment in the past 6 months
- Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment. They may be participating in another trial, if this study is approved by the investigators of the other trial.
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 |
|---|---|---|
| KlueKlue is a software program the uses an Apple watch to detect hand motions which are indicative of eating. | Device | Klue |
Primary outcome
Change in the number of missed meal boluses
Time frame: The two weeks prior to each study visit
A missed meal bolus is defined by no insulin dose within 2 hours from the start of the CGM rise.
2 secondary outcomes
Change in time in range
Time frame: data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject
Positive predictive value of a Klue meal alert
Time frame: All data for the 6 weeks on the Klue intervention arm when Klue is active
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 Sep 2021.
- 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.
- 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.
Bruce Buckingham, MD principal investigator
Stanford University
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 in people with Type1 Diabetes Mellitus, run by Stanford University 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 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 2 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?
Change in the number of missed meal boluses (time frame: The two weeks prior to each study 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 NCT03970889, which also lists 2 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 2 Sep 2021.