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.
A randomized controlled trial (RCT) will evaluate 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ+ technology 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. Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the intervention group using the t:slim X2 insulin pump with Control-IQ+ technology or to continue their pretrial insulin-delivery method for 13 weeks. Both arms used the Dexcom G6 CGM. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
319
The t:slim X2 insulin pump with Control-IQ+ technology, used with the Dexcom G6 CGM.
Standard therapy is continuation of pre-study basal-bolus insulin delivery method, plus use of Dexcom G6 CGM.
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
HbA1c
Change in HbA1c (%) from baseline between the intervention and control groups
Time frame: 13 weeks
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
Time frame: 13 weeks
Mean Glucose
Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups
Time frame: 13 weeks
Time >180 mg/dL
Change in CGM percent time \>180 mg/dL from baseline, compared between the intervention and control groups
Time frame: 13 weeks
Time >250 mg/dL
Change in CGM percent time \>250 mg/dL from baseline, compared between the intervention and control groups
Time frame: 13 weeks
Prolonged Hyperglycemia Events Per Week
Change in number of prolonged hyperglycemia events (\>90 minutes \>300 mg/dL within a 120-minute period) per week from baseline, compared between the intervention and control groups
Time frame: 13 weeks
Time <70 mg/dL
Change in CGM percent time \<70 mg/dL from baseline, compared between the intervention and control groups
Time frame: 13 weeks
Time <54 mg/dL
Change in CGM percent time \<54 mg/dL from baseline, compared between the intervention and control groups
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Baltimore, Maryland, United States
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Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
...and 11 more locations
Time frame: 13 weeks
CGM-measured Hypoglycemia Events Per Week
Change in number of CGM-measured hypoglycemia events per week (15 or more consecutive minutes \<54 mg/dL) from baseline, compared between the intervention and control groups
Time frame: 13 weeks
Coefficient of Variation
Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups
Time frame: 13 weeks