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

Type 2 Diabetes Treated With Insulin Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05785832
• Other study ID #: TP-0013437
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 335
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. 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:

1. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).

2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).

3. Placement of an intrauterine device or intrauterine hormone-releasing system.

4. Bilateral tubal occlusion.

5. Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).

6. Has a vasectomized or sterile partner (where partner is sole partner of subject) and where vasectomy has been confirmed by medical assessment.

7. 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

2. 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

Device:
• t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM
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.
• Standard Therapy plus continuous glucose monitoring (CGM)
Standard therapy is continuation of pre-study basal-bolus insulin delivery method, plus use of Dexcom G6 CGM.

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario
Canada	McGill University	Montréal	Quebec
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Texas Diabetes and Endocrinology, P.A.	Austin	Texas
United States	Baltimore VA Medical Center	Baltimore	Maryland
United States	Boston Medical Center Corporation	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	UHH Cleveland Medical Center	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Rainier Clinical Research Center	Renton	Washington
United States	Mayo Clinic	Rochester	Minnesota
United States	Diabetes & Endocrine Treatment Specialists	Sandy	Utah
United States	University of Washington	Seattle	Washington
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.	Jaeb Center for Health Research

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1c <7.0%	Number of participants with HbA1c <7.0% at 13 weeks, compared between the intervention and control groups	13 weeks
Other	HbA1c <7.0% in participants with baseline HbA1c >7.5%	Number of participants with HbA1c <7.0% at 13 weeks, in participants with baseline HbA1c >7.5%, compared between the intervention and control groups	13 weeks
Other	HbA1c <7.5%	Number of participants with HbA1c <7.5% at 13 weeks, compared between the intervention and control groups	13 weeks
Other	HbA1c improvement from baseline to 13 weeks >0.5%	Number of participants with HbA1c improvement from baseline to 13 weeks >0.5%, compared between the intervention and control groups	13 weeks
Other	HbA1c improvement from baseline to 13 weeks >1.0%	Number of participants with HbA1c improvement from baseline to 13 weeks >1.0%, compared between the intervention and control groups	13 weeks
Other	HbA1c relative improvement from baseline to 13 weeks >10%	Number of participants with HbA1c relative improvement from baseline to 13 weeks >10%, compared between the intervention and control groups	13 weeks
Other	HbA1c improvement from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks	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	13 weeks
Other	Time in range 70-140 mg/dL	Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Other	Area over the curve (70 mg/dL)	CGM area over the curve (70 mg/dL), compared between the intervention and control groups	13 weeks
Other	Low blood glucose index	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.	13 weeks
Other	Time >300 mg/dL	Change in CGM percent time >300 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Other	Area under the curve (180 mg/dL)	CGM area under the curve (180 mg/dL), compared between the intervention and control groups	13 weeks
Other	High blood glucose index	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.	13 weeks
Other	Time in range 70-180 mg/dL >70%	Number of participants with time in range 70-180 mg/dL >70%, compared between the intervention and control groups	13 weeks
Other	Time in range 70-180 mg/dL improvement from baseline to 13 weeks =5%	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	13 weeks
Other	Time in range 70-180 mg/dL improvement from baseline to 13 weeks =10%	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	13 weeks
Other	Time <70 mg/dL <4%	Number of participants with CGM time <70 mg/dL <4%, compared between the intervention and control groups	13 weeks
Other	Time <54 mg/dL <1%	Number of participants with CGM time <54 mg/dL <1%, compared between the intervention and control groups	13 weeks
Other	Time in range 70-180 mg/dL >70% and time <54 mg/dL <1%	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	13 weeks
Other	Total Insulin	Total daily insulin delivery (units), compared between the intervention and control groups	13 weeks
Other	Basal insulin	Percentage of insulin delivered as basal, compared between the intervention and control groups	13 weeks
Other	Weight	Change in weight (kg) from baseline, compared between the intervention and control groups	13 weeks
Other	Blood Pressure	Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups	13 weeks
Other	Lipid levels	Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups	13 weeks
Other	Cardiovascular events	Number of cardiovascular events, compared between the intervention and control groups	13 weeks
Other	Type 2 Diabetes Distress Assessment System (T2-DDAS Combined - Core and Source)	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	13 weeks
Other	DAWN Impact of Diabetes Profile (DIDP)	Patient-reported outcome (PRO) measures from DAWN Impact of Diabetes Profile (DIDP) questionnaire, compared between the intervention and control groups	13 weeks
Other	Diabetes Impact and Satisfaction (DIDS) Scale	Patient-reported outcome (PRO) measures from Diabetes Impact and Satisfaction (DIDS) Scale questionnaire, compared between the intervention and control groups	13 weeks
Other	PROMIS Sleep-Related Impairment Questionnaire	Patient-reported outcome (PRO) measures from PROMIS Sleep-Related Impairment questionnaire, compared between the intervention and control groups	13 weeks
Other	System Usability Scale (SUS)	Patient-reported outcome (PRO) measures from System Usability Scale (SUS) questionnaire, compared between the intervention and control groups	13 weeks
Other	Hypoglycemia Fear Survey II	Patient-reported outcome (PRO) measures from Hypoglycemia Fear Survey II, compared between the intervention and control groups	13 weeks
Other	EQ5D-5L	Patient-reported outcome (PRO) measures from EQ5D-5L questionnaire, compared between the intervention and control groups	13 weeks
Other	Study-specific survey	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	13 weeks
Other	Hypoglycemia Frequency Last 3 Months Survey	Number of non-severe hypoglycemic events reported, compared between the intervention and control groups from baseline report to 13 weeks.	13 weeks
Other	Severe hypoglycemia	Number of Severe hypoglycemia events, compared between the intervention and control groups	13 weeks
Other	Diabetic ketoacidosis	Number of Diabetic ketoacidosis events, compared between the intervention and control groups	13 weeks
Other	Hyperosmolar hyperglycemic syndrome	Number of Hyperosmolar hyperglycemic syndrome events, compared between the intervention and control groups	13 weeks
Other	Other serious adverse events	Number of other serious adverse events	13 weeks
Other	Unanticipated adverse device effects	Number of Unanticipated adverse device effects	13 weeks
Other	Infusion set failures	Number of infusion set failures	13 weeks
Other	Other device malfunctions/device issues	Number of other device malfunctions/device issues	13 weeks
Primary	HbA1c	Change in HbA1c (%) from baseline between the intervention and control groups	13 weeks
Secondary	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	13 weeks
Secondary	Mean glucose	Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups	13 weeks
Secondary	Time >180 mg/dL	Change in CGM percent time >180 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Secondary	Time >250 mg/dL	Change in CGM percent time >250 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Secondary	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	13 weeks
Secondary	Time <70 mg/dL	Change in CGM percent time <70 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Secondary	Time <54 mg/dL	Change in CGM percent time <54 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Secondary	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	13 weeks
Secondary	Coefficient of variation	Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups	13 weeks