Type 1 Diabetes
Conditions
Keywords
Advanced Hybrid Closed Loop, Meal Gesture Dosing, Klue™ Health App
Brief summary
The purpose of this feasibility study is to evaluate subject safety of using the Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) within the AHCL system in adult subjects with type 1 diabetes in a clinic setting.
Detailed description
This study is a single-center, single arm study in adult subjects with type 1 diabetes utilizing AHCL System with meal gesture detection and micro dosing (meal gesture dosing). Meal gesture dosing is a mode whereby meal announcements are not entered manually by the user. Instead, when meal gesture dosing is active, meal announcements are generated automatically by the system based on the detection of eating gestures and micro doses of insulin are given. Overall subject participation will be approximately 3 weeks to 6 months. A total of up to 40 subjects (aged 18-75) may be enrolled at one investigational center in Israel to have at least 16 subjects complete the study. The study consists of a run-in period and a study period. The run-in period is intended to allow subjects to become familiar with using the study pump system with the SmartGuard feature active and wearing the watch. Subjects should use the same insulin they will be using during the study period. During the first week of the study period, subjects will undergo a 5-day at-home baseline meal challenge at specific meals on each day. The Klue app will be set to monitoring-mode. After run-in period and completion of the 5-day at-home study period with baseline meal challenges, study subjects will check into the clinic for a 5-day (4 nights) intervention. Study subjects will wear the system with Klue meal gesture dosing activated for the entire duration of the 5-day intervention.
Interventions
DEVICEMiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)
The AHCL system with Meal Gesture Dosing evaluated in this study includes a commercial/CE-Marked insulin pump with investigational software, and the Klue Health mobile app with investigational software (installed on Apple Watch) for meal gesture detection and micro dosing.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is age 18-75 years at time of screening 2. Has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via source documentation 3. Pump therapy for greater than 6 months prior to screening 4. Real-time continuous glucose monitoring (RT-CGM) experience greater than 3 months prior to screening 5. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units 6. Is willing to perform ≥2 fingerstick blood glucose measurements daily 7. Is willing to perform required sensor calibrations 8. Is willing to wear the system continuously throughout the study 9. If subject has celiac disease, it has been adequately treated as determined by the investigator 10. If the subject has had any of the following cardiovascular events more than 1 year prior to of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances they should be cleared by a cardiologist prior to participation, if deemed necessary by the investigator. 11. If the subject has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances, they should be cleared by a cardiologist prior to participation. 12. Is of legal age and capable of providing consent 13. Is fluent in speaking, reading and understanding English
Exclusion criteria
1. Has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening: 1. Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) 2. Coma 3. Seizures 2. Has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes 3. Has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening. 4. Is unable to tolerate tape adhesive in the area of sensor placement 5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) 6. Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study 7. Women who are breastfeeding 8. Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator. 9. Is being treated for hyperthyroidism at time of Screening 10. Has a diagnosis of adrenal insufficiency 11. Is using hydroxyurea at time of screening or plans to use it during the study 12. Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks 13. Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgement 14. Is using pramlintide (Symlin), DPP-4 inhibitor, GLP-1 agonists (as liraglutide (Victoza or other), metformin, SGLT2 inhibitors (as canagliflozin (Invokana)) at time of screening 15. Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator 16. Is diagnosed with current eating disorder such as anorexia or bulimia 17. Has been diagnosed with chronic kidney disease that results in chronic anemia 18. Is on dialysis 19. Is a member of the research staff involved with executing the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Range (Phase 1, Software Release Tag 1.0) | 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. | 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 |
| Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | 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. | 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 |
Countries
Israel
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Phase 1 (Software Release Tag 1.0) | Withdrawal by Subject | 1 |
| Phase 2 (Software Release Tag 2.0) | Physician Decision | 1 |
Baseline characteristics
| Characteristic | AHCL System With Meal Gesture Detection and Micro Dosing (Meal Gesture Dosing) | — |
|---|---|---|
| Age, Continuous | 39.4 Years STANDARD_DEVIATION 12.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Israel | 28 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 1 / 18 | 1 / 18 |
| serious Total, serious adverse events | 1 / 18 | 0 / 18 |
Outcome results
Primary
Percentage of Time in Range (Phase 1, Software Release Tag 1.0)
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| In-Clinic | Percentage of Time in Range (Phase 1, Software Release Tag 1.0) | Meal 5 (Typical Meal Size with Low Carbohydrate Count) | 73.5 percentage of time | Standard Deviation 30.5 |
| In-Clinic | Percentage of Time in Range (Phase 1, Software Release Tag 1.0) | Meal 1 (Large Meal with Low Carbohydrate Count) | 84.3 percentage of time | Standard Deviation 14.9 |
| In-Clinic | Percentage of Time in Range (Phase 1, Software Release Tag 1.0) | Meal 2 (Small Meal with High Carbohydrate Count) | 48 percentage of time | Standard Deviation 28.1 |
| In-Clinic | Percentage of Time in Range (Phase 1, Software Release Tag 1.0) | Meal 3 (Typical Meal Size with Medium Carbohydrate Count) | 70.9 percentage of time | Standard Deviation 27.4 |
| In-Clinic | Percentage of Time in Range (Phase 1, Software Release Tag 1.0) | Meal 4 (Typical Meal Size with High Carbohydrate Count) | 27.3 percentage of time | Standard Deviation 12.2 |
Primary
Percentage of Time in Range (Phase 2, Software Release Tag 2.0)
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| At-Home | 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 |
| In-Clinic | Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | Meal 8 (Typical Meal Size with Low Carbohydrate Count) | 90.8 percentage of time | Standard Deviation 14.2 |
| In-Clinic | Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | Meal 1 (Long Meal with Low Carbohydrate Count) | 88.2 percentage of time | Standard Deviation 16 |
| In-Clinic | Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | Meal 2 (Large Meal with Low Carbohydrate Count) | 73.7 percentage of time | Standard Deviation 33 |
| In-Clinic | Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | Meal 3 (Small Meal with High Carbohydrate Count) | 59.9 percentage of time | Standard Deviation 26.8 |
| In-Clinic | Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | Meal 4 (Large Drink with No Carbohydrates) | 84.3 percentage of time | Standard Deviation 18.1 |
| In-Clinic | Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | Meal 5 (Typical Meal Size with Medium Carbohydrate Count) | 76.4 percentage of time | Standard Deviation 26.9 |
| In-Clinic | Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | Meal 6 (Long Meal with High Carbohydrates) | 62.8 percentage of time | Standard Deviation 33 |
| In-Clinic | Percentage of Time in Range (Phase 2, Software Release Tag 2.0) | Meal 7 (Large Drink with High Carbohydrate) | 67.8 percentage of time | Standard Deviation 25.6 |