- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03591354
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
An Extension Study of t:Slim X2 With Control-IQ Technology
Study Overview
Status
Conditions
Detailed Description
Participants in the 6 month primary trial (DCLP3) will be invited to continue in this 3-month extension study (DCLP3 Extension) following completion of the primary trial. The closed-loop control (CLC) Intervention Group participants from the primary trial will be randomly assigned to continue CLC or to switch to Predictive Low-Glucose Suspend (PLGS) therapy with t:slim X2 with Basal-IQ and Dexcom G6 for 3 months. The Sensor-Augmented Pump (SAP) Control Group participants from the primary trial will be assigned to CLC using t:slim X2 with Control-IQ Technology and Dexcom G6 (CGM) for 3 months. Upon completion of the extension study, subjects will be invited to participate in continued use of the Control-IQ Technology until the equipment has received FDA approval for commercial use.
This extension phase has two separate objectives:
Objective 1: Among participants who used CLC in the primary trial: the primary efficacy outcome for the randomized controlled trial (RCT) is time in target range 70-180 mg/dL measured by CGM in CLC group vs. PLGS group over 3 months. Safety outcomes also will be assessed Objective 2: Among participants who used SAP in the primary trial: the primary outcome is to obtain additional safety data. Efficacy also will be assessed as a pre-post within participant analysis
Note: Primary Trial (DCLP3) is NCT03563313
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Santa Barbara, California, United States, 93105
- Sansum Diabetes Research Institute
-
Stanford, California, United States, 94304
- Stanford University
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Barbara Davis Center, University of Colorado
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Harvard University (Joslin Diabetes Center)
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- University of Virginia Center for Diabetes Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Successful completion of the original 6-month RCT within the prior 14 days
- 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 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.
- For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
- Willingness to not use a personal CGM for the duration of the study
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
Exclusion Criteria
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., Dexcom, Inc., or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Closed Loop Control (CLC)
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 Continuous Glucose Monitor (CGM) for 3 months. Objective 1: This arm is participants who had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial) Objective 2: This arm is participants who had 6 months of sensor-augmented pump (SAP) in the primary trial (DCLP3 Pivotal Trial) Objective 3: This arm is participants who had 3 months of CLC in the extension trial (DCLP3 Extension) will continue use of the Control-IQ Technology & Dexcom G6 CGM until the product is commercially available. |
Participants will use the Tandem t:slim X2 insulin pump with Control-IQ Technology & Dexcom G6 CGM for 3 months.
|
ACTIVE_COMPARATOR: Predictive-Low Glucose Suspend (PLGS)
Participants randomized to Predictive-Low Glucose Suspend (PLGS) will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Objective 1: This arm is participants who had 6 months of PLGS in the primary trial (DCLP3 Pivotal Trial) Objective 2: This arm is not applicable to objective 2 Objective 3: This arm is participants who had 3 months of PLGS in the extension trial (DCLP3 Extension) will continue use of the Control-IQ Technology & Dexcom G6 CGM until the product is commercially available. |
Participants will use a Tandem t:slim X2 insulin pump with Basal-IQ and a study CGM (Dexcom G6) for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time in Target Range
Time Frame: 13 weeks
|
The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS.
Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CGM Time Above 180
Time Frame: 13 weeks
|
CGM-measured % above 180 mg/dL
|
13 weeks
|
CGM Mean Glucose
Time Frame: 13 weeks
|
CGM-measured mean glucose
|
13 weeks
|
CGM Time Below 70
Time Frame: 13 weeks
|
CGM-measured % below 70 mg/dL
|
13 weeks
|
CGM Time Below 54
Time Frame: 13 weeks
|
CGM-measured % below 54 mg/dL
|
13 weeks
|
CGM Time in Range 70-140 mg/dL
Time Frame: 13 weeks
|
CGM-measured % in range 70-140 mg/dL
|
13 weeks
|
Coefficient of Variation
Time Frame: 13 weeks
|
CGM measured glucose variability measured with the coefficient of variation (CV)
|
13 weeks
|
Standard Deviation
Time Frame: 13 weeks
|
CGM measured glucose variability measured with the standard deviation (SD)
|
13 weeks
|
CGM Time Below 60
Time Frame: 13 weeks
|
CGM-measured % below 60 mg/dL
|
13 weeks
|
LBGI
Time Frame: 13 weeks
|
Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia.
Values <1 suggest minimal risk.
Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index.
Diabetes Care 21:1870-1875, 1998)
|
13 weeks
|
CGM Hypoglycemia Events
Time Frame: 13 weeks
|
CGM-measured events of at least 15 consecutive minutes <70 mg/dL
|
13 weeks
|
CGM Time >250
Time Frame: 13 weeks
|
CGM-measured % >250 mg/dL
|
13 weeks
|
CGM Time >300
Time Frame: 13 weeks
|
CGM-measured % >300 mg/dL
|
13 weeks
|
HBGI
Time Frame: 13 weeks
|
High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia.
Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL.
Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data.
Diabetes Technol Ther 2003;5:817-828pmid:14633347)
|
13 weeks
|
HbA1c at 13 Weeks
Time Frame: 13 weeks
|
HbA1c at 13 weeks.
|
13 weeks
|
HbA1c <7.0% at 13 Weeks
Time Frame: 13 weeks
|
HbA1c <7.0% at 13 weeks.
|
13 weeks
|
HbA1c <7.5% at 13 Weeks
Time Frame: 13 weeks
|
HbA1c <7.5% at 13 weeks.
|
13 weeks
|
HbA1c Change From Baseline to 13 Weeks >0.5%
Time Frame: 13 weeks
|
HbA1c change from baseline to 13 weeks >0.5%.
|
13 weeks
|
HbA1c Change From Baseline to 13 Weeks >1.0%
Time Frame: 13 weeks
|
HbA1c change from baseline to 13 weeks >1.0%.
|
13 weeks
|
HbA1c Relative Change From Baseline to 13 Weeks >10%
Time Frame: 13 weeks
|
HbA1c relative change from baseline to 13 weeks >10%.
|
13 weeks
|
HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks
Time Frame: 13 weeks
|
HbA1c change from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks.
|
13 weeks
|
HFS-II Adult
Time Frame: 13 weeks
|
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia. |
13 weeks
|
HFS-II Teen
Time Frame: 13 weeks
|
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses.The teen survey has a total of 25 items and the range of Total scores is 0 to 100. |
13 weeks
|
HFS-II Parents
Time Frame: 13 weeks
|
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108. |
13 weeks
|
Hyperglycemia Avoidance Scale
Time Frame: 13 weeks
|
Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia.
|
13 weeks
|
Diabetes Distress Scale
Time Frame: 13 weeks
|
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.
|
13 weeks
|
Hypoglycemia Confidence Scale
Time Frame: 13 weeks
|
Hypoglycemia Confidence Scale has 9 items which are self-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.
|
13 weeks
|
Clarke Hypoglycemia Awareness Scores
Time Frame: 13 weeks
|
Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)
|
13 weeks
|
INSPIRE Survey Scores- Adults
Time Frame: 13 weeks
|
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.
|
13 weeks
|
INSPIRE Survey Scores- Teens
Time Frame: 13 weeks
|
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 Teens/Adolescents survey has 17 items.
|
13 weeks
|
INSPIRE Survey Scores- Parents
Time Frame: 13 weeks
|
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 Parent survey has 21 items.
|
13 weeks
|
System Usability Scores (SUS)
Time Frame: 13 weeks
|
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability
|
13 weeks
|
Technology Acceptance Questionnaire
Time Frame: 13 weeks
|
Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance.
There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185.
|
13 weeks
|
Total Daily Insulin
Time Frame: 13 weeks
|
Total Daily Insulin (units/kg)
|
13 weeks
|
Basal:Bolus Insulin Ratio
Time Frame: 13 weeks
|
Basal:Bolus Insulin Ratio.
|
13 weeks
|
Weight
Time Frame: 13 weeks
|
Weight (kg)
|
13 weeks
|
BMI
Time Frame: 13 weeks
|
Body Mass Index (BMI) kg/m2
|
13 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
Time Frame: 13 weeks
|
Ketone events defined as day with ketone level > 1.0 mmol/L
|
13 weeks
|
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
Time Frame: 13 weeks
|
CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL).
|
13 weeks
|
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
Time Frame: 13 weeks
|
CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL).
|
13 weeks
|
Worsening of HbA1c From Randomization to 13 Weeks by >0.5%
Time Frame: 13 weeks
|
Worsening of HbA1c from randomization to 13 weeks by >0.5%.
|
13 weeks
|
Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects)
Time Frame: 13 weeks
|
Serious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects).
|
13 weeks
|
Adverse Device Effects (ADE) That do Not Meet Criteria for SAE
Time Frame: 13 weeks
|
Adverse device effects (ADE) that do not meet criteria for SAE.
|
13 weeks
|
Other Serious Adverse Events Not Related to a Study Device
Time Frame: 13 weeks
|
Other serious adverse events not related to a study device.
|
13 weeks
|
Severe Hypoglycemic Events
Time Frame: 13 weeks
|
Number of Severe Hypoglycemic events over initial 13 weeks of trial
|
13 weeks
|
Severe Hypoglycemic Event Rate Per 100 Person-years
Time Frame: 13 weeks
|
Number of severe hypoglycemic events per 100 person-years over initial 13 weeks of trial
|
13 weeks
|
Diabetic Ketoacidosis (DKA) Events
Time Frame: 13 weeks
|
Number of DKA events over initial 13 weeks of trial
|
13 weeks
|
Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years
Time Frame: 13 weeks
|
Number of DKA events per 100 person-years over initial 13 weeks
|
13 weeks
|
Any Adverse Event Rate Per 100 Person-years
Time Frame: 13 weeks
|
Number of adverse events per 100 person-years over initial 13 weeks
|
13 weeks
|
Time in Target Range From Months 4-12
Time Frame: Months 4-12
|
CGM time in target range 70-180mg/dL for all participants using CLC from Months 4-12.
|
Months 4-12
|
CGM Time Above 180 From Months 4-12
Time Frame: Months 4-12
|
CGM-measured % above 180mg/dL from Months 4-12
|
Months 4-12
|
CGM Mean Glucose From Months 4-12
Time Frame: Months 4-12
|
CGM-measured mean glucose from Months 4-12
|
Months 4-12
|
CGM Time Below 70 From Months 4-12
Time Frame: Months 4-12
|
CGM-measured % below 70 mg/dL from Months 4-12
|
Months 4-12
|
CGM Time Below 54 From Months 4-12
Time Frame: Months 4-12
|
CGM-measured % time below 54mg/dL from Months 4-12
|
Months 4-12
|
CGM Time in Range 70-140 mg/dL From Months 4-12
Time Frame: Months 4-12
|
CGM-measured % time in range 70-140mg/dL from Months 4-12
|
Months 4-12
|
Coefficient of Variation From Months 4-12
Time Frame: Months 4-12
|
CGM measured glucose variability measured with the coefficient of variation from Months 4-12
|
Months 4-12
|
Standard Deviation From Months 4-12
Time Frame: Months 4-12
|
CGM measured glucose variability measured with the standard deviation (SD) from Months 4-12
|
Months 4-12
|
CGM Time Below 60 From Months 4-12
Time Frame: Months 4-12
|
CGM-measured % below 60mg/dL from Months 4-12
|
Months 4-12
|
LBGI From Months 4-12
Time Frame: Months 4-12
|
LBGI from Months 4-12.
Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia.
Values <1 suggest minimal risk.
Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index.
Diabetes Care 21:1870-1875, 1998)
|
Months 4-12
|
HBGI From Months 4-12
Time Frame: Months 4-12
|
HBGI from Months 4-12.
High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia.
Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL.
Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data.
Diabetes Technol Ther 2003;5:817-828pmid:14633347)
|
Months 4-12
|
CGM Hypoglycemia Events From Months 4-12
Time Frame: Months 4-12
|
CGM-measured events of at least 15 consecutive minutes <70mg/dL from Months 4-12
|
Months 4-12
|
CGM Time >250 From Months 4-12
Time Frame: Months 4-12
|
CGM-measured % time >250 mg/dL from Months 4-12
|
Months 4-12
|
CGM Time >300 From Months 4-12
Time Frame: Months 4-12
|
CGM-measured % time >300 mg/dL from Months 4-12
|
Months 4-12
|
HbA1c at Month 6
Time Frame: Month 6 of study
|
HbA1c measured at Month 6 of this extension study
|
Month 6 of study
|
HbA1c at Month 9
Time Frame: Month 9 of study
|
HbA1c measured at month 9 of this extension study
|
Month 9 of study
|
HbA1c at Month 12
Time Frame: Month 12 of study
|
HbA1c measured at Month 12 of this extension study
|
Month 12 of study
|
Ketone Events Defined as Days With Ketone Level >1.0 mmol/L From Months 4-12
Time Frame: Months 4-12
|
Ketone Events Defined as Number of Days with at least one Ketone Level >1.0 mmol/L from Months 4-12
|
Months 4-12
|
CGM-measured Hypoglycemia Events (>15 Minutes With Glucose Concentration <54mg/dL) From Months 4-12
Time Frame: Months 4-12
|
CGM-measured Hypoglycemia Events (>15 minutes with glucose concentration <54mg/dL) from Months 4-12 measured as a rate per week.
|
Months 4-12
|
CGM-measured Hyperglycemic Events From Months 4-12
Time Frame: Months 4-12
|
CGM-measured Hyperglycemic Events (>15 consecutive minutes with CGM glucose >300mg/dL) from Months 4-12
|
Months 4-12
|
Number of Severe Hypoglycemic Events From Months 4-12
Time Frame: Months 4-12
|
Number of Severe Hypoglycemic Events from Months 4-12.
|
Months 4-12
|
Number of Diabetic Ketoacidosis (DKA) Events From Months 4-12
Time Frame: Months 4-12
|
Number of Diabetic Ketoacidosis (DKA) events from Months 4-12.
|
Months 4-12
|
Other Serious Adverse Events Not Related to a Study Device From Months 4-12
Time Frame: Months 4-12
|
Other Serious Adverse Events Not Related to a Study Device from Months 4-12.
|
Months 4-12
|
Any Adverse Event Rate Per 100 Person-years From Months 4-12
Time Frame: Months 4-12
|
Any Adverse Event Rate per 100 person-years from Months 4-12.
|
Months 4-12
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCLP3 Extension
- UC4DK108483 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
The Data Sharing Agreements will be formulated by the Steering Committee in collaboration with the NIH Project Scientist Program Official.
In addition, under special arrangements, complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to "...generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems in the target population of people with type 1 diabetes."
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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