Real-time Reminders To Decrease Late or Missed Meal Boluses

Type1 Diabetes Mellitus Clinical Trial

— Klue  

Official title:

Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970889
• Other study ID #: 47137
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: August 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 30, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

1. Age 13 and over

2. On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM

3. Willing to wear a CGM at least 70% of the time while in the study

4. Using an iPhone

5. Willing to wear an Apple watch on their dominant hand while awake

6. Missing or late in giving at least four food boluses in the previous two weeks

7. Understanding and willingness to follow the protocol and sign informed consent

8. Ability to speak, read and write in the language of the investigators

Exclusion Criteria:

1. Pregnant or lactating

2. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol

3. Current treatment for a seizure disorder

4. 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Device:
• Klue
Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.

Locations

Country	Name	City	State
United States	Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Positive predictive value of a Klue meal alert	Percent of time a meal alert signaled a meal	All data for the 6 weeks on the Klue intervention arm when Klue is active