NCT04201496已完成1 期
SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus
Ananda Basu, MD2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年2月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- CGM-measured time in the target range 70-180mg/dl (TIR) during the day
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and efficacy of combining SGLT2 inhibitors with closed loop control (CLC).
详细描述
The first five participants will be enrolled in a Pilot Study to use the Basal-IQ with Empagliflozin 10 mg daily for approximately two weeks. These participants will participate in an estimated 36-48-hour hotel admission to initiate use of Closed Loop Control. The safety data from the Pilot Study will be presented to the Data Safety Monitoring Board (DSMB) for review.
Upon DSMB approval, approximately 40 participants will be randomized 1:1 in a crossover design. Participants will use empagliflozin 5 mg daily. This main study is a randomized control trial where approximately 50 participants, aged 18 to less than 65 y.o. at time of consent, will be in the trial for up to 10 weeks.
With empagliflozin:
- Control-IQ (CiQ) x 4 weeks (CiQ-EMPA) then Basal-IQ x 2 weeks (BiQ-EMPA)
- Basal-IQ x 2 weeks (BiQ-EMPA) then CiQ x 4 weeks (CiQ-EMPA)
Without empagliflozin:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18.0 and ≤65 years old at time of consent
- •Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- •Currently using an insulin pump for at least six months
- •Currently using insulin for at least six months
- •Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
- •Access to internet and willingness to upload data during the study as needed
- •For females, not currently known to be pregnant or breastfeeding
- •If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- •Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- •Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- •Total daily insulin dose (TDD) at least 10 U/day
- •Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- •Willingness to eat at least 100 grams of carbohydrates per day
- •An understanding and willingness to follow the protocol and signed informed consent
- •Pilot Participants: Agree to hotel/research house admission with other Pilot participants on a date selected by the study team.
排除标准
- •Hemoglobin A1c >9%
- •History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- •Pregnancy or intent to become pregnant during the trial
- •Currently breastfeeding or planning to breastfeed
- •Currently being treated for a seizure disorder
- •Planned surgery during study duration
- •History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
- •Clinically significant electrocardiogram (ECG) abnormality at time of Screening, as interpreted by the study medical physician
- •Use of diuretics (e.g. Lasix, Thiazides)
- •History of chronic or recurrent genital infections
- •eGFR lab value below 60 mL/min/1.73 m2
- •Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
- •Severe renal impairment, end-stage renal disease, or dialysis
- •Inpatient psychiatric treatment in the past six months
- •Presence of a known adrenal disorder
- •Abnormal liver function test results (Transaminase>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
- •Uncontrolled thyroid disease
- •Severe renal impairment, end-stage renal disease, or dialysis
- •Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
- •Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial
- •Alcohol restricted to no more than 2 drinks per night in men and no more than 1 drink per night in women
- •Low carb diet (less than 100g per day)
结局指标
主要结局
CGM-measured time in the target range 70-180mg/dl (TIR) during the day
时间窗: 6 weeks
CGM-measured time in the target range 70-180mg/dl (TIR) during the day
次要结局
- Episodes of diabetes ketoacidosis (DKA)(6 weeks)
- Number of hyperglycemic episodes as defined by contiguous CGM above 300 mg/dL(6 weeks)
- Glucose variability index ADRR(6 weeks)
- Time below 70 mg/dl(6 weeks)
- Time above 180 mg/dl(6 weeks)
- Time between 70-140 mg/dl 5 hours post prandial(6 weeks)
- Glucose variability index HBGI(6 weeks)
- Glucose variability index LBGI(6 weeks)
- Urinary Tract Infections(6 weeks)
- Episodes of severe hypoglycemia (glucose <50 mg/dL)(6 weeks)
- Genital infections(6 weeks)
- Total amount of insulin used(6 weeks)
- Safety evaluation of empagliflozin as adjuvant therapy added to a closed loop artificial pancreas system(6 weeks)
研究者
Ananda Basu, MD
Principal Investigator
University of Virginia
研究点 (2)
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