A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ+ Technology in Adults With Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP)
概览
- 阶段
- 不适用
- 干预措施
- t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM
- 疾病 / 适应症
- Type 2 Diabetes Treated With Insulin
- 发起方
- Tandem Diabetes Care, Inc.
- 入组人数
- 319
- 试验地点
- 40
- 主要终点
- HbA1c
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
干预措施: t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM
Control group
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
干预措施: Standard Therapy plus continuous glucose monitoring (CGM)
结局指标
主要结局
HbA1c
时间窗: 13 weeks
Change in HbA1c (%) from baseline between the intervention and control groups
次要结局
- Time in Range 70-180 mg/dL(13 weeks)
- Mean Glucose(13 weeks)
- Time >180 mg/dL(13 weeks)
- Time >250 mg/dL(13 weeks)
- Prolonged Hyperglycemia Events Per Week(13 weeks)
- Time <70 mg/dL(13 weeks)
- Time <54 mg/dL(13 weeks)
- CGM-measured Hypoglycemia Events Per Week(13 weeks)
- Coefficient of Variation(13 weeks)