Trial Outcomes & Findings for Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes (NCT NCT04964128)
NCT ID: NCT04964128
Last Updated: 2023-09-13
Results Overview
Overall mean percentage of Post-prandial Time in range (% of SG within 70-180 mg/dL) at home and In-Clinic Period during Phase 1
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic). The time in range metrics are considered in a 4 hours window after each of the test meals.
Results posted on
2023-09-13
Participant Flow
Phase 1 studied the Klue Health app with investigational software release tag 1.0, and Phase 2 studied the Klue Health App with investigational software release tag 2.0. Both phases included Run-In and Study Periods. The participant flow numbers for each phase reflect the participation through both the run-in and study periods within the phase. Both phases had 18 total participants starting the phase, with 8 subjects being unique to each phase. 10 subjects participated in both Phases 1 and 2.
Participant milestones
| Measure |
AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
18-75 year old subjects with type 1 diabetes utilizing AHCL System with meal gesture detection and micro dosing (meal gesture dosing)
|
|---|---|
|
Phase 1 (Software Release Tag 1.0)
STARTED
|
18
|
|
Phase 1 (Software Release Tag 1.0)
COMPLETED
|
17
|
|
Phase 1 (Software Release Tag 1.0)
NOT COMPLETED
|
1
|
|
Phase 2 (Software Release Tag 2.0)
STARTED
|
18
|
|
Phase 2 (Software Release Tag 2.0)
COMPLETED
|
17
|
|
Phase 2 (Software Release Tag 2.0)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
18-75 year old subjects with type 1 diabetes utilizing AHCL System with meal gesture detection and micro dosing (meal gesture dosing)
|
|---|---|
|
Phase 1 (Software Release Tag 1.0)
Withdrawal by Subject
|
1
|
|
Phase 2 (Software Release Tag 2.0)
Physician Decision
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing)
n=28 Participants
18-75 year old subjects with type 1 diabetes utilizing AHCL System with meal gesture detection and micro dosing (meal gesture dosing)
|
|---|---|
|
Age, Continuous
|
39.4 Years
STANDARD_DEVIATION 12.1 • n=28 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=28 Participants
|
|
Region of Enrollment
Israel
|
28 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic). The time in range metrics are considered in a 4 hours window after each of the test meals.Population: Number of participants only includes those that had data available
Overall mean percentage of Post-prandial Time in range (% of SG within 70-180 mg/dL) at home and In-Clinic Period during Phase 1
Outcome measures
| Measure |
At-Home
n=17 Participants
Phase 1 studied the Klue Health app with investigational software release tag 1.0.
This portion refers to the baseline 5-day meal challenges done at home.
|
In-Clinic
n=17 Participants
Phase 1 studied the Klue Health app with investigational software release tag 1.0.
This portion refers to the 5-day intervention done in clinic.
|
|---|---|---|
|
Percentage of Time in Range (Phase 1, Software Release Tag 1.0)
Meal 1 (Large Meal with Low Carbohydrate Count)
|
76.1 percentage of time
Standard Deviation 28.7
|
84.3 percentage of time
Standard Deviation 14.9
|
|
Percentage of Time in Range (Phase 1, Software Release Tag 1.0)
Meal 2 (Small Meal with High Carbohydrate Count)
|
65.5 percentage of time
Standard Deviation 35.7
|
48 percentage of time
Standard Deviation 28.1
|
|
Percentage of Time in Range (Phase 1, Software Release Tag 1.0)
Meal 3 (Typical Meal Size with Medium Carbohydrate Count)
|
70 percentage of time
Standard Deviation 33.5
|
70.9 percentage of time
Standard Deviation 27.4
|
|
Percentage of Time in Range (Phase 1, Software Release Tag 1.0)
Meal 4 (Typical Meal Size with High Carbohydrate Count)
|
63.9 percentage of time
Standard Deviation 28.8
|
27.3 percentage of time
Standard Deviation 12.2
|
|
Percentage of Time in Range (Phase 1, Software Release Tag 1.0)
Meal 5 (Typical Meal Size with Low Carbohydrate Count)
|
82.7 percentage of time
Standard Deviation 25
|
73.5 percentage of time
Standard Deviation 30.5
|
PRIMARY outcome
Timeframe: Overall subject participation lasted approximately 3 weeks to 6 months, which included a 5 day at-home and a 5-day in-clinic period. The time in range metrics are considered in a 4 hours window after each of the test meals.Population: Number of participants only includes those that had data available
Overall mean percentage of Post-prandial Time in range (% of SG within 70-180 mg/dL) at home and In-Clinic Period during Phase 2
Outcome measures
| Measure |
At-Home
n=17 Participants
Phase 1 studied the Klue Health app with investigational software release tag 1.0.
This portion refers to the baseline 5-day meal challenges done at home.
|
In-Clinic
n=17 Participants
Phase 1 studied the Klue Health app with investigational software release tag 1.0.
This portion refers to the 5-day intervention done in clinic.
|
|---|---|---|
|
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
Meal 1 (Long Meal with Low Carbohydrate Count)
|
76.8 percentage of time
Standard Deviation 26.5
|
88.2 percentage of time
Standard Deviation 16
|
|
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
Meal 2 (Large Meal with Low Carbohydrate Count)
|
81 percentage of time
Standard Deviation 30.8
|
73.7 percentage of time
Standard Deviation 33
|
|
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
Meal 3 (Small Meal with High Carbohydrate Count)
|
62.7 percentage of time
Standard Deviation 20.2
|
59.9 percentage of time
Standard Deviation 26.8
|
|
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
Meal 4 (Large Drink with No Carbohydrates)
|
91.9 percentage of time
Standard Deviation 14.1
|
84.3 percentage of time
Standard Deviation 18.1
|
|
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
Meal 5 (Typical Meal Size with Medium Carbohydrate Count)
|
91.8 percentage of time
Standard Deviation 10.8
|
76.4 percentage of time
Standard Deviation 26.9
|
|
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
Meal 6 (Long Meal with High Carbohydrates)
|
74.2 percentage of time
Standard Deviation 25.9
|
62.8 percentage of time
Standard Deviation 33
|
|
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
Meal 7 (Large Drink with High Carbohydrate)
|
74.8 percentage of time
Standard Deviation 16.5
|
67.8 percentage of time
Standard Deviation 25.6
|
|
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
Meal 8 (Typical Meal Size with Low Carbohydrate Count)
|
86.4 percentage of time
Standard Deviation 15.2
|
90.8 percentage of time
Standard Deviation 14.2
|
Adverse Events
Phase 1 (Software Release Tag 1.0)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2 (Software Release Tag 2.0)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 (Software Release Tag 1.0)
n=18 participants at risk
Phase 1 studied the Klue Health app with investigational software release tag 1.0
|
Phase 2 (Software Release Tag 2.0)
n=18 participants at risk
Phase 2 studied the Klue Health app with investigational software release tag 2.0
|
|---|---|---|
|
Metabolism and nutrition disorders
Severe Hypoglycemia
|
5.6%
1/18 • Number of events 1 • Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic).
|
0.00%
0/18 • Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic).
|
Other adverse events
| Measure |
Phase 1 (Software Release Tag 1.0)
n=18 participants at risk
Phase 1 studied the Klue Health app with investigational software release tag 1.0
|
Phase 2 (Software Release Tag 2.0)
n=18 participants at risk
Phase 2 studied the Klue Health app with investigational software release tag 2.0
|
|---|---|---|
|
Gastrointestinal disorders
Indigestion
|
5.6%
1/18 • Number of events 1 • Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic).
|
0.00%
0/18 • Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic).
|
|
Infections and infestations
Viral infection
|
0.00%
0/18 • Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic).
|
5.6%
1/18 • Number of events 1 • Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic).
|
|
Infections and infestations
Epididymitis
|
0.00%
0/18 • Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic).
|
5.6%
1/18 • Number of events 1 • Overall subject participation lasted approximately 3 weeks to 6 months, which included a run-in period and a study period (5 days at-home and 5 days in-clinic).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60