Type 1 DiabetesDCLP4NCT04436796

The International Diabetes Closed Loop (iDCL) Trial: Protocol 4

A study testing interoperable Artificial Pancreas System (iAPS) and Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) in people with Type 1 Diabetes, run by Sansum Diabetes Research Institute at 5 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes
What is being tested?: interoperable Artificial Pancreas System (iAPS) and Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 5 sitesUnited States
Study dates: 5 Aug 2020to 10 May 2021
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
Using an insulin pump for at least 3 months (which may include use of automated features)
Familiarity and use of a carbohydrate ratio for meal boluses
Age ≥18.0 years old
For females, not currently known to be pregnant. 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 child-bearing 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.
If using a personal CGM, willingness to use a Dexcom G6 CGM and discontinue personal CGM use during the study

Show all 10Show fewer

Willing not to begin use of, or not to continue use of if currently using, a personal AID (closed loop control) system during the study; note if the system offers an open-loop mode or can be switched to a PLGS mode that is compatible with the Dexcom G6, the system may be used during the study in these modes only
Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial, and not to use Afrezza during the trial
Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol

Who cannot join

Use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless participant is willing to discontinue during the trial.
Two or more episodes of DKA requiring an emergency room visit or hospitalization in the past 6 months
Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in the last 6 months
Hemophilia or any other bleeding disorder
A medical or other condition that in the opinion of the investigator could create a safety concern for the participant or put the study at risk. History of frequent severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis, without emergency room visit or hospitalization, due to poor diabetes self-management may be disqualifying per investigator judgment
Participation in another pharmaceutical or device trial at the time of enrollment or during the study

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Joslin Diabetes Center
Boston, Massachusetts, 02215
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Stanford University
Stanford, California, 94304

Other trials in United States

About this study

Official title: The International Diabetes Closed Loop (iDCL) Trial: A Randomized Crossover Comparison of Adaptive Model Predictive Control (MPC) Artificial Pancreas Versus Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) in the Outpatient Setting in Type 1 Diabetes (DCLP4)

Read the detailed description

A randomized crossover trial will compare the efficacy and safety of an automated insulin delivery (AID) study system using an adaptive Model Predictive Control (MPC) algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) therapy in people with type 1 diabetes for 13 weeks in each arm of the study. A Pilot Phase using the study system for 10-14 days will be conducted prior to the crossover trial.

Conditions: Type 1 Diabetes
Being tested: interoperable Artificial Pancreas System (iAPS), Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)
Keywords: Artificial Pancreas, Automated Insulin Delivery, Closed Loop Control, Continuous Glucose Monitor (CGM), interoperable Artificial Pancreas System (iAPS)
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.

interoperable Artificial Pancreas System (iAPS)Device
Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)Other
Use of personal pump with study CGM \& glucometer at home for 13 weeks.

Study groups in NCT04436796
Study group	Role	What they receive
Artificial Pancreas	Experimental	Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. Receives: Device: interoperable Artificial Pancreas System (iAPS)
Sensor Augmented Pump/Predictive Low Glucose Suspend	Active comparator	Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Receives: Other: Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)

What is being measured

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

Percent CGM Time in Range 70-180 mg/dL
This results shown is mean percent time in range 70-180 mg/dL.
Measured: 13 weeks
Non-inferiority for CGM Time <54 mg/dL
Superiority for time in range 70-180 mg/dL and non-inferiority for time <54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure
Measured: 13 weeks

Secondary outcomes (22)

CGM Mean Glucose
CGM-measured mean glucose (mg/dL)
Measured: 13 weeks
CGM Time > 180
CGM time > 180 mg/dL
Measured: 13 weeks
CGM Time > 250
CGM time > 250 mg/dL
Measured: 13 weeks
CGM Time < 70
CGM time < 70 mg/dL
Measured: 13 weeks
CGM Time < 54 (Superiority)
CGM time < 54 mg/dL (Superiority)
Measured: 13 weeks
Coefficient of Variation
CGM measured glucose variability measured with the coefficient of variation (CV)
Measured: 13 weeks
CGM Time in Range 70-140 mg/dL
CGM-measured % in range 70-140 mg/dL
Measured: 13 weeks
Standard Deviation
CGM measured glucose variability measured with the standard deviation (SD)
Measured: 13 weeks
CGM Time < 60
CGM time < 60 mg/dL
Measured: 13 weeks
LBGI
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia.
Measured: 13 weeks
CGM Time > 300
CGM time > 300 mg/dL
Measured: 13 weeks
HBGI
High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia
Measured: 13 weeks
HbA1c at 13 Weeks
Hemiglobin A1c measured after completing each study arm
Measured: 13 weeks
Number of Participants With HbA1c <7.0% at 13 Weeks
Number of participants HbA1c <7.0% after completing each study arm
Measured: 13 weeks
Number of Participants With HbA1c <7.5% at 13 Weeks
Number of participants HbA1c <7.5% after completing each study arm
Measured: 3 months
Diabetes Distress Scale at 13 Weeks - Total Score
Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.
Measured: 13 weeks
Glucose Monitoring Satisfaction Survey (Total Scale)
The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5)
Measured: 13 weeks
Hypoglycemia Confidence Scale
Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.
Measured: 13 weeks
INSPIRE Survey Scores - Following Study System Period Only
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.
Measured: 13 weeks
SUS Survey Scores - Following Study System Period
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
Measured: 13 weeks
Total Daily Insulin
Total Daily Insulin (units)
Measured: 13 weeks
Basal: Bolus Insulin Ratio
Basal: bolus insulin ratio
Measured: 13 weeks

Timeline

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

5 Aug 202010 May 2021

First posted18 Jun 2020
Study start5 Aug 2020
Primary completion10 May 2021
Study completion10 May 2021

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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04436796
Sponsor's protocol ID: G200047
Other IDs: UC4DK108483
Acronym: DCLP4
Status last verified: Nov 2022
First submitted: 16 Jun 2020
Last updated: 2 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series \& boluses, will be deidentified \& retrievable only by subject ID number. Individual patterns of demographic \& insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes \& not to identify participants; (2) a commitment to securing the data using appropriate computer technology; \& (3) a commitment to destroying or returning the data after analyses are completed.

Publications

Pinsker JE, Dassau E, Deshpande S, Raghinaru D, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Church MM, Desrochers H, Ekhlaspour L, Kaur RJ, Levister C, Shi D, Lum JW, Kollman C, Doyle FJ; iDCL Trial Research Group. Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4. Diabetes Technol Ther. 2022 Sep;24(9):635-642. doi: 10.1089/dia.2022.0084. Epub 2022 Jun 2.
PubMed 35549708

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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The International Diabetes Closed Loop (iDCL) Trial: A Randomized Crossover Comparison of Adaptive Model Predictive Control (MPC) Artificial Pancreas Versus Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) in the Outpatient Setting in Type 1 Diabetes (DCLP4)
ClinicalTrials.gov ID: NCT04436796
Acronym / sponsor ID: DCLP4 / G200047
Conditions: Type 1 Diabetes
Keywords: Artificial Pancreas, Automated Insulin Delivery, Closed Loop Control, Continuous Glucose Monitor (CGM), interoperable Artificial Pancreas System (iAPS)
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Sansum Diabetes Research InstituteUniversity, hospital or other
Collaborators: Harvard University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research
Study start: 5 Aug 2020 (actual)
Primary completion: 10 May 2021 (actual)
Study completion: 10 May 2021 (actual)
First posted: 18 Jun 2020 (actual)
Results: Posted 2 Dec 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Artificial Pancreas	Experimental	Device: interoperable Artificial Pancreas System (iAPS)Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes.
Sensor Augmented Pump/Predictive Low Glucose Suspend	Active comparator	Other: Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
Using an insulin pump for at least 3 months (which may include use of automated features)
Familiarity and use of a carbohydrate ratio for meal boluses
Age ≥18.0 years old
For females, not currently known to be pregnant. 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 child-bearing 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.

Key exclusion criteria (6 listed)

Use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) unless participant is willing to discontinue during the trial.
Two or more episodes of DKA requiring an emergency room visit or hospitalization in the past 6 months
Two or more episodes of severe hypoglycemia with seizure or loss of consciousness in the last 6 months
Hemophilia or any other bleeding disorder
A medical or other condition that in the opinion of the investigator could create a safety concern for the participant or put the study at risk. History of frequent severe hypoglycemia or history of frequent severe hyperglycemia and/or ketosis, without emergency room visit or hospitalization, due to poor diabetes self-management may be disqualifying per investigator judgment

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
interoperable Artificial Pancreas System (iAPS)Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.	Device	Artificial Pancreas
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)Use of personal pump with study CGM \& glucometer at home for 13 weeks.	Other	Sensor Augmented Pump/Predictive Low Glucose Suspend

Primary outcome

Percent CGM Time in Range 70-180 mg/dL
Time frame: 13 weeks
This results shown is mean percent time in range 70-180 mg/dL.
Non-inferiority for CGM Time <54 mg/dL
Time frame: 13 weeks
Superiority for time in range 70-180 mg/dL and non-inferiority for time <54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure

22 secondary outcomes

CGM Mean Glucose
Time frame: 13 weeks
CGM Time > 180
Time frame: 13 weeks
CGM Time > 250
Time frame: 13 weeks
CGM Time < 70
Time frame: 13 weeks
CGM Time < 54 (Superiority)
Time frame: 13 weeks
Coefficient of Variation
Time frame: 13 weeks
CGM Time in Range 70-140 mg/dL
Time frame: 13 weeks
Standard Deviation
Time frame: 13 weeks
CGM Time < 60
Time frame: 13 weeks
LBGI
Time frame: 13 weeks
CGM Time > 300
Time frame: 13 weeks
HBGI
Time frame: 13 weeks
HbA1c at 13 Weeks
Time frame: 13 weeks
Number of Participants With HbA1c <7.0% at 13 Weeks
Time frame: 13 weeks
Number of Participants With HbA1c <7.5% at 13 Weeks
Time frame: 3 months
Diabetes Distress Scale at 13 Weeks - Total Score
Time frame: 13 weeks
Glucose Monitoring Satisfaction Survey (Total Scale)
Time frame: 13 weeks
Hypoglycemia Confidence Scale
Time frame: 13 weeks
INSPIRE Survey Scores - Following Study System Period Only
Time frame: 13 weeks
SUS Survey Scores - Following Study System Period
Time frame: 13 weeks
Total Daily Insulin
Time frame: 13 weeks
Basal: Bolus Insulin Ratio
Time frame: 13 weeks

Results and safety

Results posted to the registry on 2 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Artificial Pancreas First, Then Sensor-Augmented Pump/Predicitive Low Glucose Suspend	19	19
Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas	16	16

Primary outcome: Percent CGM Time in Range 70-180 mg/dL

Time frame: 13 weeks. Mean (Standard Deviation). Unit: percentage of time

Measure	Artificial Pancreas n = 35	Sensor Augmented Pump/Predictive Low Glucose Suspend n = 35
Value	69 (14)	66 (14)

Primary outcome: Non-inferiority for CGM Time <54 mg/dL

Time frame: 13 weeks. Mean (Standard Deviation). Unit: percentage of time

Measure	Artificial Pancreas n = 35	Sensor Augmented Pump/Predictive Low Glucose Suspend n = 35
Value	0.41 (0.39)	0.71 (0.82)

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: From protocol entry through last study date which is approximately 26-28 weeks per participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Artificial Pancreas	0 of 35 (0%)	4 of 35 (11.4%)	0 of 35
Sensor Augmented Pump/Predictive Low Glucose Suspend	1 of 35 (2.9%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35549708Pinsker JE, Dassau E, Deshpande S, Raghinaru D, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Church MM, Desrochers H, Ekhlaspour L, Kaur RJ, Levister C, Shi D, Lum JW, Kollman C, Doyle FJ; iDCL Trial Research Group. Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4. Diabetes Technol Ther. 2022 Sep;24(9):635-642. doi: 10.1089/dia.2022.0084. Epub 2022 Jun 2.
Individual participant dataSharing planned: Yes. NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series \& boluses, will be deidentified \& retrievable only by subject ID number. Individual patterns of demographic \& insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes \& not to identify participants; (2) a commitment to securing the data using appropriate computer technology; \& (3) a commitment to destroying or returning the data after analyses are completed.

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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.

Eyal Dassau, PhD study chair

Harvard University

Jordan Pinsker, MD study chair

Sansum Diabetes Research Institute

Francis J Doyle III, PhD principal investigator

Harvard University

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

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 6 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 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 2 Dec 2022). 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?

Percent CGM Time in Range 70-180 mg/dL (time frame: 13 weeks). The study lists 2 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 NCT04436796, 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 2 Dec 2022.