Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

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.

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.

Eligibility Criteria:
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.