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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Klue | Device | Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The two weeks prior to each study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in time in range | sensor glucose values between 70-180 mg/dl | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Buckingham, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14993580 | Background | 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. | |
| 19175898 | Background | Olinder 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. |
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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.
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Percent of time a meal alert signaled a meal
| All data for the 6 weeks on the Klue intervention arm when Klue is active |