Diabetes Mellitus, Type 2NCT05951569
Loop T2D Observational Study
An observational study of Diabetes Mellitus, Type 2, run by Jaeb Center for Health Research at 1 site in United States.
Trial summary
An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived OS-AID Loop System on adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Community-Derived Open-Source Automated Insulin Delivery Loop System
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 8 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with type 2 diabetes using the community-derived open-source automated insulin delivery Loop system.
Who may be able to join
- Type 2 diabetes
- Age ≥18 years old
- Currently using any version of Loop other than v3.0.0 or planning to start using any version of Loop other than v3.0.0 Loop within the next 30 days
- Willing and able to provide informed consent and to complete surveys and provide the device data that are part of the protocol
- Resident of the US
- English speaking/reading
- Access to email/phone
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Jaeb Center for Health Research
Tampa, Florida, 33647
About this study
Official title: An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System
An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived OS-AID Loop System on adults with type 2 diabetes.
Read the detailed description
The study will include adults with type 2 diabetes in the United States, with a recruitment goal of a maximum of 100 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and user experience/treatment satisfaction surveys.
Follow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using Loop.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Community-Derived Open-Source Automated Insulin Delivery Loop System
- Keywords
- Loop, Type 2 Diabetes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Derived Open-Source Automated Insulin Delivery Loop SystemDevice
The Loop System consists of an insulin pump and a Dexcom CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
Number of DKA events and event outcomes. DKA events are defined as hospitalization with documentation of arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate (or CO2) <15.
Measured: Up to 3 months
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
Number of severe hypoglycemic events and event outcomes. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.
Measured: Up to 3 months
Measure of Loop Safety by Self-Report of Hospitalization Events
Number of hospitalizations
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start20 Jun 2023
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Embecta Medical, Tidepool Project
- Responsible party
- Sponsor
- Investigators
- Colleen Bauza, PhD, MPH, Principal investigator, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951569
- Sponsor's protocol ID
- T2D Loop
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lum JW, Bailey RJ, Barnes-Lomen V, Naranjo D, Hood KK, Lal RA, Arbiter B, Brown AS, DeSalvo DJ, Pettus J, Calhoun P, Beck RW. A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System. Diabetes Technol Ther. 2021 May;23(5):367-375. doi: 10.1089/dia.2020.0535. Epub 2021 Apr 12.
PubMed 33226840Bauza C, Kanapka LG, Greene E, Lal RA, Arbiter B, Beck RW. Use of the Community-Derived Open-Source Automated Insulin Delivery Loop System in Type 2 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):494-497. doi: 10.1089/dia.2023.0569. Epub 2024 Apr 8.
PubMed 38386434
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System
- ClinicalTrials.gov ID
- NCT05951569
- Acronym / sponsor ID
- T2D Loop
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Loop, Type 2 Diabetes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Embecta Medical, Tidepool Project
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived OS-AID Loop System on adults with type 2 diabetes.
Detailed description
The study will include adults with type 2 diabetes in the United States, with a recruitment goal of a maximum of 100 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and user experience/treatment satisfaction surveys.
Follow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using Loop.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with type 2 diabetes using the community-derived open-source automated insulin delivery Loop system.
Key inclusion criteria (7 listed)
- Type 2 diabetes
- Age ≥18 years old
- Currently using any version of Loop other than v3.0.0 or planning to start using any version of Loop other than v3.0.0 Loop within the next 30 days
- Willing and able to provide informed consent and to complete surveys and provide the device data that are part of the protocol
- Resident of the US
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Community-Derived Open-Source Automated Insulin Delivery Loop SystemThe Loop System consists of an insulin pump and a Dexcom CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system. | Device | – |
Primary outcome
Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
Time frame: Up to 3 months
Number of DKA events and event outcomes. DKA events are defined as hospitalization with documentation of arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate (or CO2) <15.
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
Time frame: Up to 3 months
Number of severe hypoglycemic events and event outcomes. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.
Measure of Loop Safety by Self-Report of Hospitalization Events
Time frame: Up to 3 months
Number of hospitalizations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Results publication: PubMed 33226840Lum JW, Bailey RJ, Barnes-Lomen V, Naranjo D, Hood KK, Lal RA, Arbiter B, Brown AS, DeSalvo DJ, Pettus J, Calhoun P, Beck RW. A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System. Diabetes Technol Ther. 2021 May;23(5):367-375. doi: 10.1089/dia.2020.0535. Epub 2021 Apr 12.
- Derived from this study: PubMed 38386434Bauza C, Kanapka LG, Greene E, Lal RA, Arbiter B, Beck RW. Use of the Community-Derived Open-Source Automated Insulin Delivery Loop System in Type 2 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):494-497. doi: 10.1089/dia.2023.0569. Epub 2024 Apr 8.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
RecruitingObservational study
Washed Microbiota Transplantation for Type 1 Diabetes Mellitus
Type 1 Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
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.
Colleen Bauza, PhD, MPH principal investigator
Jaeb Center for Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Jaeb Center for Health Research at 1 site 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 7 inclusion and 1 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events (time frame: Up to 3 months). The study lists 3 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 NCT05951569, which also lists 2 linked publications.
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 12 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.