Rocky Mountain Clinical Research, LLC | Idaho Falls, ID
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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.
Full 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.
Enrollment
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Ages
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:
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
Primary purpose
Allocation
Interventional model
Masking
335 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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