Type 1 DiabetesNCT04203823

Feasibility Studies of Personalized Closed Loop

A study testing Cloud-based Digital Twin and Meal Prediction algorithms in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single arm study comprised of a series of feasibility studies. Read more about this study

Who is it for?: Ages 2 to 80 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Cloud-based Digital Twin and Meal Prediction algorithms
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 12 sitesUnited States
Study dates: 20 Jul 2020to 27 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

General 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
Study-specific inclusion criteria

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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.
If subject has celiac disease, it has been adequately treated as determined by the investigator.
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)

Who cannot join

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).

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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.
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.
Subject is being treated for hyperthyroidism at time of Visit 1.
Subject has a diagnosis of adrenal insufficiency.
Subject has had Diabetic Ketoacidosis (DKA) within 1 year prior to Visit 1.
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.
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.
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.
Subject is currently abusing illicit drugs.
Subject is currently abusing alcohol.
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.
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.
Subject has elective surgery planned that requires general anesthesia during the course of the study.
Subject diagnosed with current eating disorder such as anorexia or bulimia.
Subject has been diagnosed with chronic kidney disease that results in chronic anemia.
Subject is on dialysis.
Subject has serum creatinine of >2 mg/dL, as confirmed through historical labs within 1 year prior to Visit 1.
Subject is a member the research staff involved with the study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Barbara Davis Center - Adults
Aurora, Colorado, 80045
Barbara Davis Center / Pediatric
Aurora, Colorado, 80045
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, 38133
Rocky Mountain Diabetes
Idaho Falls, Idaho, 83404
Loma Linda University Medical Center
Loma Linda, California, 92354
Rainier Clinical Research
Renton, Washington, 98057
Mayo Clinic
Rochester, Minnesota, 55905
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076
Park Nicollet International Diabetes Center
Saint Louis Park, Minnesota, 55416
University of South Florida Diabetes Center
Tampa, Florida, 33612
Diablo Clinical Research
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: Feasibility Study With Personalized Closed Loop (PCL)

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

Read the 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

Conditions: Type 1 Diabetes
Being tested: Cloud-based Digital Twin and Meal Prediction algorithms
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cloud-based Digital Twin and Meal Prediction algorithmsDevice
Test safety and effectiveness of the Digital Twin and Meal Prediction algorithms

Study groups in NCT04203823
Study group	Role	What they receive
Algorithm Testing	Experimental	The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm and the Meal Prediction algorithm The study population will be enrolled as 2 separate cohorts to test each algorithms individually Receives: Device: Cloud-based Digital Twin and Meal Prediction algorithms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202027 Jan 2022

First posted18 Dec 2019
Study start20 Jul 2020
Primary completion27 Jan 2022
Study completion27 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single Arm (Cohort) assignment
Masking: None (open label)
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04203823
Sponsor's protocol ID: CIP326
Status last verified: Apr 2023
First submitted: 13 Dec 2019
Last updated: 9 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study With Personalized Closed Loop (PCL)
ClinicalTrials.gov ID: NCT04203823
Acronym / sponsor ID: CIP326
Conditions: Type 1 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: 20 Jul 2020 (actual)
Primary completion: 27 Jan 2022 (actual)
Study completion: 27 Jan 2022 (actual)
First posted: 18 Dec 2019 (actual)
Results: Posted 15 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single Arm (Cohort) assignment

Arm	Type	Receives
Algorithm Testing	Experimental	Device: Cloud-based Digital Twin and Meal Prediction algorithmsThe main purpose of this cohort is to test the Digital Twin insulin delivery algorithm and the Meal Prediction algorithm The study population will be enrolled as 2 separate cohorts to test each algorithms individually

Who may qualify

Ages: 2 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (14 listed)

General 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.
Study-specific inclusion criteria
Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.

Key exclusion criteria (25 listed)

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
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cloud-based Digital Twin and Meal Prediction algorithmsTest safety and effectiveness of the Digital Twin and Meal Prediction algorithms	Device	Algorithm Testing

Primary outcome

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

Results and safety

Results posted to the registry on 15 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A	54	51
Cohort C	72	65

Primary outcome: Number of Severe Hypoglycemic Event - Cohort A

Time frame: approximately 3.5 months. Number. Unit: events

Measure	Cohort A n = 54
Value	0

Primary outcome: Number of Diabetic Ketoacidosis (DKA) Event - Cohort A

Time frame: approximately 3.5 months. Number. Unit: events

Measure	Cohort A n = 54
Value	0

Primary outcome: Percentage of Time in Euglycemia - Cohort A

Time frame: approximately 3.5 months. Mean (Standard Deviation). Unit: percentage of time

Measure	Cohort A n = 53
Value	70.5 (10.7)

Population analysed: Participants in Cohort A with device data (1 did not have device data)

Primary outcome: Number of Severe Hypoglycemic Event - Cohort C

Time frame: approximately 3.5 months. Number. Unit: events

Measure	Cohort C n = 72
Value	0

Adverse events

Time frame: Individual subjects were participating in Feasibility 2 for approximately 3.5 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A	0 of 54 (0%)	14 of 54 (25.9%)	0 of 54
Cohort C	0 of 72 (0%)	22 of 72 (30.6%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cloud-based Digital Twin and Meal Prediction algorithms in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Severe Hypoglycemic Event - Cohort A (time frame: approximately 3.5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04203823.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.