CompletedNot Applicable

Feasibility Studies of Personalized Closed Loop

United States126 participantsStarted 2020-07-20

Plain-language summary

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

Who can participate

Age range2 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Subject has a clinical diagnosis of type 1 diabetes.
✓. Subjects 7 years of age and older: Diagnosed at least 1 year prior to Visit 1
✓. Subjects 2-6 years of age: Diagnosed at least 3 months prior to Visit 1
✓. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
✓. 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
✓. 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.
✓. 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.

Exclusion criteria

✕. 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
✕. Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
✕. Coma
✕. Seizures
✕. Subject is unable to tolerate tape adhesive in the area of sensor placement.
✕. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
✕. 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
✕. 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.

What they're measuring

Number of Severe Hypoglycemic Event - Cohort A

Timeframe: approximately 3.5 months

Number of Diabetic Ketoacidosis (DKA) Event - Cohort A

Timeframe: approximately 3.5 months

Percentage of Time in Euglycemia - Cohort A

Timeframe: approximately 3.5 months

Number of Severe Hypoglycemic Event - Cohort C

Timeframe: approximately 3.5 months

Number of Diabetic Ketoacidosis (DKA) Event - Cohort C

Timeframe: approximately 3.5 months

Percentage of Time in Euglycemia - Cohort C

Timeframe: approximately 3.5 months

Trial details

NCT IDNCT04203823

SponsorMedtronic MiniMed, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-27

Results submitted2023-01-20

View on ClinicalTrials.gov More Type 1 Diabetes trials

Who can participate

Age range2 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. Subject has a clinical diagnosis of type 1 diabetes.
✓. Subjects 7 years of age and older: Diagnosed at least 1 year prior to Visit 1
✓. Subjects 2-6 years of age: Diagnosed at least 3 months prior to Visit 1
✓. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
✓. 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
✓. 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.
✓. 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.

Exclusion criteria

✕. 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
✕. Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
✕. Coma
✕. Seizures
✕. Subject is unable to tolerate tape adhesive in the area of sensor placement.
✕. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
✕. 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
✕. 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.

What they're measuring

Number of Severe Hypoglycemic Event - Cohort A

Timeframe: approximately 3.5 months

Number of Diabetic Ketoacidosis (DKA) Event - Cohort A

Timeframe: approximately 3.5 months

Percentage of Time in Euglycemia - Cohort A

Timeframe: approximately 3.5 months

Number of Severe Hypoglycemic Event - Cohort C

Timeframe: approximately 3.5 months

Number of Diabetic Ketoacidosis (DKA) Event - Cohort C

Timeframe: approximately 3.5 months

Percentage of Time in Euglycemia - Cohort C

Timeframe: approximately 3.5 months