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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Klue App
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Klue, Meal bolus, Bolus reminder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Klue App Use then Usual Care

Usual Care then Klue App Use

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of missed meal boluses
The change in the number of missed meal boluses

Secondary Outcome Measures

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
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
Change in Hemoglobin A1c Levels
Change in Hemoglobin A1c Levels
Time in range 70-180 mg/dL
Time in range 70-180 mg/dL as measured by CGM
Time in range 70-180 mg/dL
Time in range 70-180 mg/dL as measured by CGM
Percent time <70 mg/dL mean glucose
Percent time <70 mg/dL mean glucose as measured by CGM
Percent time <70 mg/dL mean glucose
Percent time <70 mg/dL mean glucose as measured by CGM
Glucose Coefficient of Variation
Glucose (as measured by CGM) Coefficient of Variation
Glucose Coefficient of Variation
Glucose (as measured by CGM) Coefficient of Variation
Total daily insulin dose
Total daily insulin dose
Total daily insulin dose
Total daily insulin dose
Number of meal bolus injections each day
Number of meal bolus injections each day
Number of meal bolus injections each day
Number of meal bolus injections each day
Number of total bolus injections each day
Number of total bolus injections each day
Number of total bolus injections each day
Number of total bolus injections each day
Total daily basal insulin
Total daily basal insulin
Total daily basal insulin
Total daily basal insulin
Accuracy of Klue in detecting meals
Accuracy of Klue in detecting meals (true positive and false positive rates)
User satisfaction of Klue
User satisfaction of Klue
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)
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)

Full Information

First Posted
January 11, 2019
Last Updated
April 18, 2020
Sponsor
University of Virginia
Collaborators
Stanford University, Klue, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03809858
Brief Title
Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Official Title
Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Stanford University, Klue, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Klue, Meal bolus, Bolus reminder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Klue App Use then Usual Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care then Klue App Use
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Klue App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of missed meal boluses
Description
The change in the number of missed meal boluses
Time Frame
During the two weeks prior to each visit
Secondary Outcome Measure Information:
Title
Number of missed meal boluses as a measure of attenuation to the alerts
Description
The change in the number of missed meal boluses as a measure of attenuation to the alerts
Time Frame
6 weeks
Title
Number of missed meal boluses as a measure of attenuation to the alerts
Description
The change in the number of missed meal boluses as a measure of attenuation to the alerts
Time Frame
12 weeks
Title
Change in Hemoglobin A1c Levels
Description
Change in Hemoglobin A1c Levels
Time Frame
3 months
Title
Time in range 70-180 mg/dL
Description
Time in range 70-180 mg/dL as measured by CGM
Time Frame
6 weeks
Title
Time in range 70-180 mg/dL
Description
Time in range 70-180 mg/dL as measured by CGM
Time Frame
12 weeks
Title
Percent time <70 mg/dL mean glucose
Description
Percent time <70 mg/dL mean glucose as measured by CGM
Time Frame
6 weeks
Title
Percent time <70 mg/dL mean glucose
Description
Percent time <70 mg/dL mean glucose as measured by CGM
Time Frame
12 weeks
Title
Glucose Coefficient of Variation
Description
Glucose (as measured by CGM) Coefficient of Variation
Time Frame
6 weeks
Title
Glucose Coefficient of Variation
Description
Glucose (as measured by CGM) Coefficient of Variation
Time Frame
12 weeks
Title
Total daily insulin dose
Description
Total daily insulin dose
Time Frame
6 weeks
Title
Total daily insulin dose
Description
Total daily insulin dose
Time Frame
12 weeks
Title
Number of meal bolus injections each day
Description
Number of meal bolus injections each day
Time Frame
6 weeks
Title
Number of meal bolus injections each day
Description
Number of meal bolus injections each day
Time Frame
12 weeks
Title
Number of total bolus injections each day
Description
Number of total bolus injections each day
Time Frame
6 weeks
Title
Number of total bolus injections each day
Description
Number of total bolus injections each day
Time Frame
12 weeks
Title
Total daily basal insulin
Description
Total daily basal insulin
Time Frame
6 weeks
Title
Total daily basal insulin
Description
Total daily basal insulin
Time Frame
12 weeks
Title
Accuracy of Klue in detecting meals
Description
Accuracy of Klue in detecting meals (true positive and false positive rates)
Time Frame
3 months
Title
User satisfaction of Klue
Description
User satisfaction of Klue
Time Frame
3 months
Title
Diabetes-Specific Attitudes about Technology (DSAT) Scores
Description
DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)
Time Frame
3 months
Title
Diabetes Distress Scale (DDS) Scores
Description
DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Breton, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan to share individual participant data
Citations:
PubMed Identifier
14993580
Citation
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.
Results Reference
background
PubMed Identifier
19175898
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.
Results Reference
background
PubMed Identifier
21466646
Citation
O'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.
Results Reference
background
PubMed Identifier
27234809
Citation
Naranjo 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.
Results Reference
background

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

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