Feasibility Studies of Personalized Closed Loop

Feasibility Study With Personalized Closed Loop (PCL)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04203823

Enrollment

126

Registered

2019-12-18

Start date

2020-07-20

Completion date

2022-01-27

Last updated

2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

This is a single arm study comprised of a series of feasibility studies.

Detailed description

Feasibility Study Part 2 (i.e. Feasibility 2): Feasibility 2 is the focus of the current version of the study protocol. This study will include 2 separate Cohorts of individuals, based on the algorithms being studied: Cohort A: The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation Cohort C: The main purpose of this cohort is to test a meal prediction algorithm

Interventions

DEVICECloud-based Digital Twin and Meal Prediction algorithms

Test safety and effectiveness of the Digital Twin and Meal Prediction algorithms

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single Arm (Cohort) assignment

Eligibility

Sex/Gender

ALL

Age

2 Years to 80 Years

Healthy volunteers

Inclusion criteria

General Inclusion Criteria 1. Subject is age 2-80 years at time of Visit 1. Note: See staged enrollment reference for adult and pediatric subjects in the Study Design section 2. Subject has a clinical diagnosis of type 1 diabetes. 1. Subjects 7 years of age and older: Diagnosed at least 1 year prior to Visit 1 2. Subjects 2-6 years of age: Diagnosed at least 3 months prior to Visit 1 Study-specific inclusion criteria 3. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units. 4. If subject has a history of hypothyroidism, must have at least 1 documented normal thyroid-stimulating hormone (TSH) on historical labs within 12 months of Visit 1. A subject without a history of hyperthyroidism is not expected to have a TSH test 5. Subjects and their parent(s)/guardian(s) must have Internet access , a computer system that meets the requirements for uploading the study pump and Smartphone that meets study requirements. 6. Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in in the same building (or home). This requirement may be verified by subject report at screening visit. 7. If subject has celiac disease, it has been adequately treated as determined by the investigator. 8. Subjects and their parent(s)/guardian(s) are willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount) * Humalog™\* (insulin lispro injection) * NovoLog™\* (insulin aspart)

Exclusion criteria

1. Subject has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the last 1 year prior to Visit 1 1. Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) 2. Coma 3. Seizures 2. Subject is unable to tolerate tape adhesive in the area of sensor placement. 3. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 4. Women of child-bearing potential who have a positive pregnancy test at Visit 1 or plan to become pregnant during the course of the study 5. 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. 6. Subject has a cardiovascular condition which the Study Investigator determines should exclude the subject, e.g. ventricular rhythm disturbance, hypertrophic cardiomyopathy, recent myocardial infarction in the last year prior to Visit 1. 7. Subject is being treated for hyperthyroidism at time of Visit 1. 8. Subject has a diagnosis of adrenal insufficiency. 9. Subject has had Diabetic Ketoacidosis (DKA) within 1 year prior to Visit 1. 10. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of visit 1, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study. 11. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. Please note participation in observational study is acceptable. 12. Subject has been hospitalized or has visited the ER in the 6 months prior to Visit 1 resulting in a primary diagnosis of uncontrolled diabetes. 13. Subject is currently abusing illicit drugs. 14. Subject is currently abusing alcohol. 15. Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of Visit 1. 16. Subject 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. 17. Subject has elective surgery planned that requires general anesthesia during the course of the study. 18. Subject diagnosed with current eating disorder such as anorexia or bulimia. 19. Subject has been diagnosed with chronic kidney disease that results in chronic anemia. 20. Subject is on dialysis. 21. Subject has serum creatinine of \>2 mg/dL, as confirmed through historical labs within 1 year prior to Visit 1. 22. Subject is a member the research staff involved with the study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Severe Hypoglycemic Event - Cohort A	approximately 3.5 months	Number of severe hypoglycemic events occurred in the study in Cohort A
Number of Diabetic Ketoacidosis (DKA) Event - Cohort A	approximately 3.5 months	Number of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort A
Percentage of Time in Euglycemia - Cohort A	approximately 3.5 months	The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort A
Number of Severe Hypoglycemic Event - Cohort C	approximately 3.5 months	Number of severe hypoglycemic events occurred in the study in Cohort C
Number of Diabetic Ketoacidosis (DKA) Event - Cohort C	approximately 3.5 months	Number of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort C
Percentage of Time in Euglycemia - Cohort C	approximately 3.5 months	The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort C

Countries

United States

Participant flow

Participants by arm

Arm	Count
Cohort A The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation Cloud-based Digital Twin algorithms: Test safety and effectiveness of the Digital Twin algorithms	54
Cohort C The main purpose of this cohort is to test a meal prediction algorithm Cloud-based Meal Prediction algorithms: Test safety and effectiveness of the Meal Prediction algorithms	72
Total	126

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	1
Overall Study	Withdrawal by Parent/Guardian	0	4
Overall Study	Withdrawal by Subject	2	2

Baseline characteristics

Characteristic	Total	Cohort C	Cohort A
Age, Continuous	35.0 years STANDARD_DEVIATION 19.3	34.8 years STANDARD_DEVIATION 19.5	35.2 years STANDARD_DEVIATION 19.2
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants	9 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	112 Participants	62 Participants	50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Race American Indian or Alaska Native, White	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Race Asian	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Race Black or African American	3 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Race Other	2 Participants	2 Participants	0 Participants
Race/Ethnicity, Customized Race White	119 Participants	69 Participants	50 Participants
Region of Enrollment United States	126 participants	72 participants	54 participants
Sex: Female, Male Female	58 Participants	32 Participants	26 Participants
Sex: Female, Male Male	68 Participants	40 Participants	28 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 54	0 / 72
other Total, other adverse events	14 / 54	22 / 72
serious Total, serious adverse events	0 / 54	0 / 72