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A Randomized Trial Evaluating Control-IQ Technology in Adults With Type 2 Diabetes (2IQP)

Primary Purpose

Type 2 Diabetes Treated With Insulin

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM
Standard Therapy plus continuous glucose monitoring (CGM)
Sponsored by
Tandem Diabetes Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Treated With Insulin focused on measuring Control-IQ technology, type 2 diabetes, automated insulin dosing, automated insulin delivery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years old at time of screening. Currently resides in the U.S. or Canada with the ability to complete in-person study visits at one of the participating clinical sites. Clinical diagnosis, based on investigator assessment, of type 2 diabetes of at least 6 months duration at time of screening. Using basal-bolus insulin therapy with at least one injection containing rapid-acting insulin per day or an insulin pump for at least 3 months prior to enrollment, with no major modification to insulin regime in the last 3 months (mixed insulin with a rapid component is acceptable). If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications, dose has been stable for the 3 months prior to screening; and participant is willing to not change the dose unless required for safety purposes. Participant willing to not initiate use of any new glucose-lowering medications during the trial. Willing to use an approved insulin while using the study pump if assigned to the AID group. Willing to not use concentrated insulin above U-100 or inhaled insulin while using the study pump. Willing to participate in the study meal and exercise challenges if assigned to the AID group, and have a care partner, trained in hypoglycemia treatment guidelines, to include glucagon use, present during and immediately after the exercise challenges. Has the ability to read and understand written English. Investigator believes that the participant has the cognitive capacity to provide informed consent. Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study. No medical, psychiatric, or other conditions, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study. This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse. Participants capable of becoming pregnant must meet one of the following criteria: has a negative urine pregnancy test and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. The following contraceptive measures are considered adequate: Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). Placement of an intrauterine device or intrauterine hormone-releasing system. Bilateral tubal occlusion. Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository). Has a vasectomized or sterile partner (where partner is sole partner of subject) and where vasectomy has been confirmed by medical assessment. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. or Participant is of non-childbearing potential due to menopause with at least one year since last menses or a medical condition confirmed by the investigator. Exclusion Criteria: Current use of hybrid closed-loop system. Current use of systemic glucocorticoids or anticipated use of glucocorticoids during the RCT (topical or inhaled -ie, non-systemic is acceptable). Current use of sulfonylurea or meglitinide medications. Current use of hydroxyurea. Tape allergy or skin condition that will preclude use of the study pump or CGM. Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c. Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 2 months, or sexually active without use of contraception. Current participation in another diabetes-related interventional clinical trial. Anticipated change of residency or travel for more than 7 days at a time during the study that may, per investigator judgment, interfere with the completion of study visits, contacts, or procedures. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.

Sites / Locations

  • Rocky Mountain Clinical Research
  • Baltimore VA Medical Center
  • Boston Medical Center Corporation
  • Henry Ford Health System
  • Mayo ClinicRecruiting
  • Icahn School of Medicine at Mt. SinaiRecruiting
  • SUNY Upstate Medical University
  • University of PennsylvaniaRecruiting
  • Texas Diabetes and Endocrinology, P.A.Recruiting
  • Diabetes & Endocrine Treatment Specialists
  • Rainier Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the Intervention group using t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM for 13 weeks.

Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6).

Outcomes

Primary Outcome Measures

HbA1c
Change in HbA1c (%) from baseline between the intervention and control groups

Secondary Outcome Measures

Time in range 70-180 mg/dL
Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups
Mean glucose
Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups
Time >180 mg/dL
Change in CGM percent time >180 mg/dL from baseline, compared between the intervention and control groups
Time >250 mg/dL
Change in CGM percent time >250 mg/dL from baseline, compared between the intervention and control groups
Prolonged hyperglycemia events
Change in number of prolonged hyperglycemia events (>90 minutes >300 mg/dL within a 120-minute period) from baseline, compared between the intervention and control groups
Time <70 mg/dL
Change in CGM percent time <70 mg/dL from baseline, compared between the intervention and control groups
Time <54 mg/dL
Change in CGM percent time <54 mg/dL from baseline, compared between the intervention and control groups
CGM-measured hypoglycemia events
Change in number of CGM-measured hypoglycemia events (15 or more consecutive minutes <54 mg/dL) from baseline, compared between the intervention and control groups
Coefficient of variation
Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups

Full Information

First Posted
March 14, 2023
Last Updated
June 30, 2023
Sponsor
Tandem Diabetes Care, Inc.
Collaborators
Jaeb Center for Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT05785832
Brief Title
A Randomized Trial Evaluating Control-IQ Technology in Adults With Type 2 Diabetes
Acronym
2IQP
Official Title
A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ Technology in Adults With Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tandem Diabetes Care, Inc.
Collaborators
Jaeb Center for Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ technology in adults with type 2 diabetes using basal-bolus insulin therapy.
Detailed Description
A randomized controlled trial (RCT) will evaluate 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology 1.5 in adults with type 2 diabetes age 18 and older using basal-bolus insulin therapy compared with continuation of pre-study insulin delivery plus continuous glucose monitoring (CGM). At least 300 participants will complete the trial at up to 25 clinical sites, across the United States and Canada. The primary outcome is change in hemoglobin A1c (HbA1c) compared between the intervention and control group. The secondary endpoints will be tested for superiority, with a hierarchical testing approach. Additional outcomes are exploratory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Treated With Insulin
Keywords
Control-IQ technology, type 2 diabetes, automated insulin dosing, automated insulin delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the Intervention group using t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM for 13 weeks.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6).
Intervention Type
Device
Intervention Name(s)
t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM
Intervention Description
The t:slim X2 insulin pump with Control-IQ technology 1.5 is derived from the commercially available t:slim X2 with Control-IQ, with additional features. It will be used with the Dexcom G6 CGM.
Intervention Type
Device
Intervention Name(s)
Standard Therapy plus continuous glucose monitoring (CGM)
Intervention Description
Standard therapy is continuation of pre-study basal-bolus insulin delivery method, plus use of Dexcom G6 CGM.
Primary Outcome Measure Information:
Title
HbA1c
Description
Change in HbA1c (%) from baseline between the intervention and control groups
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Time in range 70-180 mg/dL
Description
Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Mean glucose
Description
Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time >180 mg/dL
Description
Change in CGM percent time >180 mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time >250 mg/dL
Description
Change in CGM percent time >250 mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Prolonged hyperglycemia events
Description
Change in number of prolonged hyperglycemia events (>90 minutes >300 mg/dL within a 120-minute period) from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time <70 mg/dL
Description
Change in CGM percent time <70 mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time <54 mg/dL
Description
Change in CGM percent time <54 mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
CGM-measured hypoglycemia events
Description
Change in number of CGM-measured hypoglycemia events (15 or more consecutive minutes <54 mg/dL) from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Coefficient of variation
Description
Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Other Pre-specified Outcome Measures:
Title
HbA1c <7.0%
Description
Number of participants with HbA1c <7.0% at 13 weeks, compared between the intervention and control groups
Time Frame
13 weeks
Title
HbA1c <7.0% in participants with baseline HbA1c >7.5%
Description
Number of participants with HbA1c <7.0% at 13 weeks, in participants with baseline HbA1c >7.5%, compared between the intervention and control groups
Time Frame
13 weeks
Title
HbA1c <7.5%
Description
Number of participants with HbA1c <7.5% at 13 weeks, compared between the intervention and control groups
Time Frame
13 weeks
Title
HbA1c improvement from baseline to 13 weeks >0.5%
Description
Number of participants with HbA1c improvement from baseline to 13 weeks >0.5%, compared between the intervention and control groups
Time Frame
13 weeks
Title
HbA1c improvement from baseline to 13 weeks >1.0%
Description
Number of participants with HbA1c improvement from baseline to 13 weeks >1.0%, compared between the intervention and control groups
Time Frame
13 weeks
Title
HbA1c relative improvement from baseline to 13 weeks >10%
Description
Number of participants with HbA1c relative improvement from baseline to 13 weeks >10%, compared between the intervention and control groups
Time Frame
13 weeks
Title
HbA1c improvement from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks
Description
Number of participants with HbA1c improvement from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time in range 70-140 mg/dL
Description
Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Area over the curve (70 mg/dL)
Description
CGM area over the curve (70 mg/dL), compared between the intervention and control groups
Time Frame
13 weeks
Title
Low blood glucose index
Description
Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia, compared between the intervention and control groups. 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.
Time Frame
13 weeks
Title
Time >300 mg/dL
Description
Change in CGM percent time >300 mg/dL from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Area under the curve (180 mg/dL)
Description
CGM area under the curve (180 mg/dL), compared between the intervention and control groups
Time Frame
13 weeks
Title
High blood glucose index
Description
High Blood Glucose Index (HBGI) by CGM, compared between the intervention and control groups., as 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.
Time Frame
13 weeks
Title
Time in range 70-180 mg/dL >70%
Description
Number of participants with time in range 70-180 mg/dL >70%, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5%
Description
Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5%, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10%
Description
Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10%, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time <70 mg/dL <4%
Description
Number of participants with CGM time <70 mg/dL <4%, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time <54 mg/dL <1%
Description
Number of participants with CGM time <54 mg/dL <1%, compared between the intervention and control groups
Time Frame
13 weeks
Title
Time in range 70-180 mg/dL >70% and time <54 mg/dL <1%
Description
Number of participants with time in range 70-180 mg/dL >70% and time <54 mg/dL <1%, compared between the intervention and control groups
Time Frame
13 weeks
Title
Total Insulin
Description
Total daily insulin delivery (units), compared between the intervention and control groups
Time Frame
13 weeks
Title
Basal insulin
Description
Percentage of insulin delivered as basal, compared between the intervention and control groups
Time Frame
13 weeks
Title
Weight
Description
Change in weight (kg) from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Blood Pressure
Description
Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Lipid levels
Description
Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups
Time Frame
13 weeks
Title
Cardiovascular events
Description
Number of cardiovascular events, compared between the intervention and control groups
Time Frame
13 weeks
Title
Type 2 Diabetes Distress Assessment System (T2-DDAS Combined - Core and Source)
Description
Patient-reported outcome (PRO) measures from Type 2 Diabetes Distress Assessment System (T2-DDAS Combined - Core and Source) questionnaire, compared between the intervention and control groups
Time Frame
13 weeks
Title
DAWN Impact of Diabetes Profile (DIDP)
Description
Patient-reported outcome (PRO) measures from DAWN Impact of Diabetes Profile (DIDP) questionnaire, compared between the intervention and control groups
Time Frame
13 weeks
Title
Diabetes Impact and Satisfaction (DIDS) Scale
Description
Patient-reported outcome (PRO) measures from Diabetes Impact and Satisfaction (DIDS) Scale questionnaire, compared between the intervention and control groups
Time Frame
13 weeks
Title
PROMIS Sleep-Related Impairment Questionnaire
Description
Patient-reported outcome (PRO) measures from PROMIS Sleep-Related Impairment questionnaire, compared between the intervention and control groups
Time Frame
13 weeks
Title
System Usability Scale (SUS)
Description
Patient-reported outcome (PRO) measures from System Usability Scale (SUS) questionnaire, compared between the intervention and control groups
Time Frame
13 weeks
Title
Hypoglycemia Fear Survey II
Description
Patient-reported outcome (PRO) measures from Hypoglycemia Fear Survey II, compared between the intervention and control groups
Time Frame
13 weeks
Title
EQ5D-5L
Description
Patient-reported outcome (PRO) measures from EQ5D-5L questionnaire, compared between the intervention and control groups
Time Frame
13 weeks
Title
Study-specific survey
Description
Patient-reported outcome (PRO) measures from study-specific survey exploring time spent on insulin management and insulin dosing with meals, compared between the intervention and control groups
Time Frame
13 weeks
Title
Hypoglycemia Frequency Last 3 Months Survey
Description
Number of non-severe hypoglycemic events reported, compared between the intervention and control groups from baseline report to 13 weeks.
Time Frame
13 weeks
Title
Severe hypoglycemia
Description
Number of Severe hypoglycemia events, compared between the intervention and control groups
Time Frame
13 weeks
Title
Diabetic ketoacidosis
Description
Number of Diabetic ketoacidosis events, compared between the intervention and control groups
Time Frame
13 weeks
Title
Hyperosmolar hyperglycemic syndrome
Description
Number of Hyperosmolar hyperglycemic syndrome events, compared between the intervention and control groups
Time Frame
13 weeks
Title
Other serious adverse events
Description
Number of other serious adverse events
Time Frame
13 weeks
Title
Unanticipated adverse device effects
Description
Number of Unanticipated adverse device effects
Time Frame
13 weeks
Title
Infusion set failures
Description
Number of infusion set failures
Time Frame
13 weeks
Title
Other device malfunctions/device issues
Description
Number of other device malfunctions/device issues
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old at time of screening. Currently resides in the U.S. or Canada with the ability to complete in-person study visits at one of the participating clinical sites. Clinical diagnosis, based on investigator assessment, of type 2 diabetes of at least 6 months duration at time of screening. Using basal-bolus insulin therapy with at least one injection containing rapid-acting insulin per day or an insulin pump for at least 3 months prior to enrollment, with no major modification to insulin regime in the last 3 months (mixed insulin with a rapid component is acceptable). If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications, dose has been stable for the 3 months prior to screening; and participant is willing to not change the dose unless required for safety purposes. Participant willing to not initiate use of any new glucose-lowering medications during the trial. Willing to use an approved insulin while using the study pump if assigned to the AID group. Willing to not use concentrated insulin above U-100 or inhaled insulin while using the study pump. Willing to participate in the study meal and exercise challenges if assigned to the AID group, and have a care partner, trained in hypoglycemia treatment guidelines, to include glucagon use, present during and immediately after the exercise challenges. Has the ability to read and understand written English. Investigator believes that the participant has the cognitive capacity to provide informed consent. Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study. No medical, psychiatric, or other conditions, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study. This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse. Participants capable of becoming pregnant must meet one of the following criteria: has a negative urine pregnancy test and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. The following contraceptive measures are considered adequate: Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable). Placement of an intrauterine device or intrauterine hormone-releasing system. Bilateral tubal occlusion. Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository). Has a vasectomized or sterile partner (where partner is sole partner of subject) and where vasectomy has been confirmed by medical assessment. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. or Participant is of non-childbearing potential due to menopause with at least one year since last menses or a medical condition confirmed by the investigator. Exclusion Criteria: Current use of hybrid closed-loop system. Current use of systemic glucocorticoids or anticipated use of glucocorticoids during the RCT (topical or inhaled -ie, non-systemic is acceptable). Current use of sulfonylurea or meglitinide medications. Current use of hydroxyurea. Tape allergy or skin condition that will preclude use of the study pump or CGM. Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c. Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 2 months, or sexually active without use of contraception. Current participation in another diabetes-related interventional clinical trial. Anticipated change of residency or travel for more than 7 days at a time during the study that may, per investigator judgment, interfere with the completion of study visits, contacts, or procedures. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Pinsker, MD
Organizational Affiliation
Tandem Diabetes Care
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yogish Kudva, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Christensen
Phone
208-522-6005
Email
rochelle.christensen@idahomed.com
First Name & Middle Initial & Last Name & Degree
David Liljenquist, MD
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Scott
Phone
410-605-7000
Ext
53558
Email
william.scott5@va.gov
First Name & Middle Initial & Last Name & Degree
Ilias Spanakis, MD
Facility Name
Boston Medical Center Corporation
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid Atakov-Castillo
Phone
617-638-5906
Email
astrid.atakovcastillo@bmc.org
First Name & Middle Initial & Last Name & Degree
Devin Steenkamp, MD
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Layton
Phone
313-916-3906
Email
playton2@hfhs.org
First Name & Middle Initial & Last Name & Degree
Davida Kruger, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corey Reid
Phone
507-255-0316
Email
reid.corey@mayo.edu
First Name & Middle Initial & Last Name & Degree
Yogish Kudva, MD
Facility Name
Icahn School of Medicine at Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Ellis
Phone
212-241-5355
Email
emily.ellis@mssm.edu
First Name & Middle Initial & Last Name & Degree
Carol Levy, MD
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzan Bzdick, RN, CDCES
Phone
315-464-9006
Email
bzdicks@upstate.edu
First Name & Middle Initial & Last Name & Degree
Ruth Weinstock, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornelia Dalton-Bakes
Phone
215-746-2085
Email
corneliv@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Michael Rickels, MD,MS
Facility Name
Texas Diabetes and Endocrinology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Armstrong
Phone
512-334-3505
Ext
1
Email
carmstrong@tderesearch.com
First Name & Middle Initial & Last Name & Degree
Thomas Blevins, MD
Facility Name
Diabetes & Endocrine Treatment Specialists
City
Sandy
State/Province
Utah
ZIP/Postal Code
84093
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aisha Fairclough
Phone
801-816-1010
Ext
108
Email
aisha@detsutah.com
First Name & Middle Initial & Last Name & Degree
Timothy Graham, MD
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alissa Levinson
Phone
425-251-1720
Email
alevinson@rainier-research.com
First Name & Middle Initial & Last Name & Degree
Frances Broyles, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomized Trial Evaluating Control-IQ Technology in Adults With Type 2 Diabetes

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