Type 1 DiabetesNCT04877730
Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
A study testing Fully Closed Loop (FCL), Fully Closed Loop with meal anticipation module (FCL+) and Hybrid Closed Loop (HCL) in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Fully Closed Loop (FCL), Fully Closed Loop with meal anticipation module (FCL+) and Hybrid Closed Loop (HCL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 6 Mar 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18.0 and ≤70 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Currently using insulin for at least six months
- Currently using insulin pump for at least three months
- Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
- Access to internet and willingness to upload data during the study as needed
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- For females, not currently known to be pregnant or breastfeeding
- If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Willingness to use the University of Virginia (UVa) closed-loop system throughout study admission
- Willingness to use the insulin supplied by the study for the hotel stay, if not already using that preparation. Study insulin will be lispro (Humalog) or aspart (Novolog)
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- Willingness to eat at least 1g/kg of carbohydrate per day during the hotel admission
- Willingness to reschedule if placed on oral steroids
- An understanding and willingness to follow the protocol and signed informed consent
- Willingness to commit to self-quarantine for at least 5 days before COVID-19 testing (If participant has received a full course of COVID-19 vaccine and data emerge suggesting significantly reduced transmissibility among those receiving that vaccine, this self-quarantine requirement can be waived.)
Who cannot join
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently being treated for a seizure disorder
- Planned surgery during study duration
- Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
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- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
- Known contact with a COVID-19 positive individual within 14 days of the hotel/rental house studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
The purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety.
Read the detailed description
This is a pilot study to assess glycemic responses to three different approaches to insulin dosing for carbohydrate ingestion, with different approaches to a closed-loop system in random order;
- without the meal anticipation module and without carbohydrate announcement (FCL)
- with the meal anticipation module and without carbohydrate announcement (FCL+)
- without the meal anticipation module and with carbohydrate announcement (HCL),
This study will target completion of up to 36 adults in a randomized cross-over trial, comparing blood glucose time in range 70-180 mg/dL following meals with and without the meal anticipation module in use (FCL+ vs FCL), and comparing to a system with carb announcement instead of a meal anticipation module (HCL). The study will also assess safety when dinner is consumed later than usual and when a lunch is consumed without having been entrained in the meal anticipation module. Each participant will complete each of the 3 modules in random order.
- Conditions
- Type 1 Diabetes
- Being tested
- Fully Closed Loop (FCL), Fully Closed Loop with meal anticipation module (FCL+), Hybrid Closed Loop (HCL)
- Keywords
- Type 1 Diabetes (T1D), Continuous Glucose Monitor (CGM), Insulin Pump, Fully Automated Closed Loop (FCL), Hybrid Closed Loop (HCL)
- 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.
Fully Closed Loop (FCL)Device
Closed loop without a meal anticipation module without announced carbohydrate
Fully Closed Loop with meal anticipation module (FCL+)Device
Closed loop with a meal anticipation module and without announced carbohydrate
Hybrid Closed Loop (HCL)Device
Closed loop without a meal anticipation module with announced carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| FCL (Fully Closed Loop) | Experimental | Closed-loop control without meal anticipation module without meal bolus Receives: Device: Fully Closed Loop (FCL) |
| FCL+ (Fully Closed Loop with meal anticipation) | Experimental | Closed-loop control with meal anticipation module without meal bolus Receives: Device: Fully Closed Loop with meal anticipation module (FCL+) |
| HCL (Hybrid Closed Loop) | Experimental | Closed-loop control without meal anticipation module with meal bolus Receives: Device: Hybrid Closed Loop (HCL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome.
Measured: The 5 hour period following breakfast during the study admission
Secondary outcomes (26)
Time in Range (TIR) 70-180 mg/dL Overall
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) during the 24hr study admission. Higher TIR is a positive outcome.
Measured: The 24 hour study admission from 4pm to 4pm
Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following dinner. Higher TIR is a positive outcome.
Measured: The 5 hour period following dinner during the study admission
Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following lunch. Higher TIR is a positive outcome.
Measured: The 5 hour period following lunch during the study admission
Time Below Range (TBR) From Breakfast Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following breakfast.
Measured: The 5 hour period following breakfast during the study admission
Time Below Range (TBR) Overall
Frequency of CGM values falling below 70 mg/dL (excluded) during the 24hr study admission.
Measured: The 24 hour study admission from 4pm to 4pm
Time Below Range (TBR) From Dinner Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following dinner.
Measured: The 5 hour period following dinner during the study admission
Time Below Range (TBR) From Lunch Time + 5 Hours
Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following lunch.
Measured: The 5 hour period following lunch during the study admission
Time Above Range (TAR) From Breakfast Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following breakfast.
Measured: The 5 hour period following breakfast during the study admission
Time Above Range (TAR) Overall
Frequency of CGM values falling above 180 mg/dL (excluded) during the 24hr study admission.
Measured: The 24 hour study admission from 4pm to 4pm
Time Above Range (TAR) From Dinner Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following dinner.
Measured: The 5 hour period following dinner during the study admission
Time Above Range (TAR) From Lunch Time + 5 Hours
Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following lunch.
Measured: The 5 hour period following lunch during the study admission
Time in Significant Hyperglycemia From Breakfast Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following breakfast.
Measured: The 5 hour period following breakfast during the study admission
Time in Significant Hyperglycemia Overall
Frequency of CGM values falling above 250 mg/dL (excluded) during the 24hr study admission.
Measured: The 24 hour study admission from 4pm to 4pm
Time in Significant Hyperglycemia From Dinner Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following dinner.
Measured: The 5 hour period following dinner during the study admission
Time in Significant Hyperglycemia From Lunch Time + 5 Hours
Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following lunch.
Measured: The 5 hour period following lunch during the study admission
Time in Significant Hypoglycemia From Breakfast Time +5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following breakfast.
Measured: The 5 hour period following breakfast during the study admission
Time in Significant Hypoglycemia Overall
Frequency of CGM values falling below 54 mg/dL (excluded) during the 24hr study admission.
Measured: The 24 hour study admission from 4pm to 4pm
Time in Significant Hypoglycemia Dinner Time + 5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following dinner.
Measured: The 5 hour period following dinner during the study admission
Time in Significant Hypoglycemia Lunch Time + 5 Hours
Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following lunch
Measured: The 5 hour period following lunch during the study admission
Number of Hypoglycemia Events From Breakfast Time + 5 Hours
Number of hypoglycemia events in the 5 hours following breakfast. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Metrics are number of hypoglycemia events per participant.
Measured: The 5 hour period following breakfast during the study admission
Number of Hypoglycemia Events Overall
Number of hypoglycemia events during the 24hr study admission. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.
Measured: The 24 hour study admission from 4pm to 4pm
Number of Hypoglycemia Events Dinner Time + 5 Hours
Number of hypoglycemia events in the 5 hours following dinner. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.
Measured: The 5 hour period following dinner during the study admission
Number of Hypoglycemia Events Lunch Time + 5 Hours
Number of hypoglycemia events in the 5 hours following lunch. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one).
Measured: The 5 hour period following lunch during the study admission
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast
Sum of all system provided insulin for breakfast (as planned) post-prandial excursion, including anticipation
Measured: The 7 hour period including the two hours before and the 5 hours after breakfast
Units of Insulin Injected (Units/kg) Overall
Calculation of all system-provided insulin (units/kg) injected during the 24hr study admission.
Measured: The 24 hour study admission from 4pm to 4pm
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner
Sum of all system provided insulin for dinner (late) post-prandial excursion, including anticipation
Measured: The 7 hour period including the 2 hours before and 5 hours after dinner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start21 May 2021
- Primary completion4 Mar 2022
- Study completion6 Mar 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Brown, University of Virginia
- Investigators
- Sue Brown, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877730
- Sponsor's protocol ID
- 210035
- Other IDs
- UC4DK108483
- Status last verified
- May 2024
- First submitted
- 26 Apr 2021
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Publications
Garcia-Tirado J, Colmegna P, Villard O, Diaz JL, Esquivel-Zuniga R, Koravi CLK, Barnett CL, Oliveri MC, Fuller M, Brown SA, DeBoer MD, Breton MD. Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes. Diabetes Care. 2023 Sep 1;46(9):1652-1658. doi: 10.2337/dc23-0119.
PubMed 37478323
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
- ClinicalTrials.gov ID
- NCT04877730
- Acronym / sponsor ID
- 210035
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes (T1D), Continuous Glucose Monitor (CGM), Insulin Pump, Fully Automated Closed Loop (FCL), Hybrid Closed Loop (HCL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety.
Detailed description
This is a pilot study to assess glycemic responses to three different approaches to insulin dosing for carbohydrate ingestion, with different approaches to a closed-loop system in random order;
- without the meal anticipation module and without carbohydrate announcement (FCL)
- with the meal anticipation module and without carbohydrate announcement (FCL+)
- without the meal anticipation module and with carbohydrate announcement (HCL),
This study will target completion of up to 36 adults in a randomized cross-over trial, comparing blood glucose time in range 70-180 mg/dL following meals with and without the meal anticipation module in use (FCL+ vs FCL), and comparing to a system with carb announcement instead of a meal anticipation module (HCL). The study will also assess safety when dinner is consumed later than usual and when a lunch is consumed without having been entrained in the meal anticipation module. Each participant will complete each of the 3 modules in random order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FCL (Fully Closed Loop) | Experimental | Device: Fully Closed Loop (FCL)Closed-loop control without meal anticipation module without meal bolus |
| FCL+ (Fully Closed Loop with meal anticipation) | Experimental | Device: Fully Closed Loop with meal anticipation module (FCL+)Closed-loop control with meal anticipation module without meal bolus |
| HCL (Hybrid Closed Loop) | Experimental | Device: Hybrid Closed Loop (HCL)Closed-loop control without meal anticipation module with meal bolus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥18.0 and ≤70 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Currently using insulin for at least six months
- Currently using insulin pump for at least three months
- Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
Key exclusion criteria (9 listed)
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently being treated for a seizure disorder
- Planned surgery during study duration
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 |
|---|---|---|
| Fully Closed Loop (FCL)Closed loop without a meal anticipation module without announced carbohydrate | Device | FCL (Fully Closed Loop) |
| Fully Closed Loop with meal anticipation module (FCL+)Closed loop with a meal anticipation module and without announced carbohydrate | Device | FCL+ (Fully Closed Loop with meal anticipation) |
| Hybrid Closed Loop (HCL)Closed loop without a meal anticipation module with announced carbohydrate | Device | HCL (Hybrid Closed Loop) |
Primary outcome
Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours
Time frame: The 5 hour period following breakfast during the study admission
Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome.
26 secondary outcomes
Time in Range (TIR) 70-180 mg/dL Overall
Time frame: The 24 hour study admission from 4pm to 4pm
Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours
Time frame: The 5 hour period following dinner during the study admission
Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours
Time frame: The 5 hour period following lunch during the study admission
Time Below Range (TBR) From Breakfast Time + 5 Hours
Time frame: The 5 hour period following breakfast during the study admission
Time Below Range (TBR) Overall
Time frame: The 24 hour study admission from 4pm to 4pm
Time Below Range (TBR) From Dinner Time + 5 Hours
Time frame: The 5 hour period following dinner during the study admission
Time Below Range (TBR) From Lunch Time + 5 Hours
Time frame: The 5 hour period following lunch during the study admission
Time Above Range (TAR) From Breakfast Time + 5 Hours
Time frame: The 5 hour period following breakfast during the study admission
Time Above Range (TAR) Overall
Time frame: The 24 hour study admission from 4pm to 4pm
Time Above Range (TAR) From Dinner Time + 5 Hours
Time frame: The 5 hour period following dinner during the study admission
Time Above Range (TAR) From Lunch Time + 5 Hours
Time frame: The 5 hour period following lunch during the study admission
Time in Significant Hyperglycemia From Breakfast Time + 5 Hours
Time frame: The 5 hour period following breakfast during the study admission
Time in Significant Hyperglycemia Overall
Time frame: The 24 hour study admission from 4pm to 4pm
Time in Significant Hyperglycemia From Dinner Time + 5 Hours
Time frame: The 5 hour period following dinner during the study admission
Time in Significant Hyperglycemia From Lunch Time + 5 Hours
Time frame: The 5 hour period following lunch during the study admission
Time in Significant Hypoglycemia From Breakfast Time +5 Hours
Time frame: The 5 hour period following breakfast during the study admission
Time in Significant Hypoglycemia Overall
Time frame: The 24 hour study admission from 4pm to 4pm
Time in Significant Hypoglycemia Dinner Time + 5 Hours
Time frame: The 5 hour period following dinner during the study admission
Time in Significant Hypoglycemia Lunch Time + 5 Hours
Time frame: The 5 hour period following lunch during the study admission
Number of Hypoglycemia Events From Breakfast Time + 5 Hours
Time frame: The 5 hour period following breakfast during the study admission
Number of Hypoglycemia Events Overall
Time frame: The 24 hour study admission from 4pm to 4pm
Number of Hypoglycemia Events Dinner Time + 5 Hours
Time frame: The 5 hour period following dinner during the study admission
Number of Hypoglycemia Events Lunch Time + 5 Hours
Time frame: The 5 hour period following lunch during the study admission
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast
Time frame: The 7 hour period including the two hours before and the 5 hours after breakfast
Units of Insulin Injected (Units/kg) Overall
Time frame: The 24 hour study admission from 4pm to 4pm
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner
Time frame: The 7 hour period including the 2 hours before and 5 hours after dinner
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37478323Garcia-Tirado J, Colmegna P, Villard O, Diaz JL, Esquivel-Zuniga R, Koravi CLK, Barnett CL, Oliveri MC, Fuller M, Brown SA, DeBoer MD, Breton MD. Assessment of Meal Anticipation for Improving Fully Automated Insulin Delivery in Adults With Type 1 Diabetes. Diabetes Care. 2023 Sep 1;46(9):1652-1658. doi: 10.2337/dc23-0119.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
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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.
Sue Brown, MD principal investigator
University of Virginia Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully Closed Loop (FCL), Fully Closed Loop with meal anticipation module (FCL+) and Hybrid Closed Loop (HCL) in people with Type 1 Diabetes, run by University of Virginia 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 16 inclusion and 9 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 23 May 2024. 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?
Yes. Results are posted in the registry (first posted 17 May 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?
Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours (time frame: The 5 hour period following breakfast during the study admission). 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 NCT04877730, which also lists 1 linked publication.
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 23 May 2024.