Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study
概览
- 阶段
- 不适用
- 干预措施
- Control-IQ use in Type 2 Diabetes under basal insulin injections
- 疾病 / 适应症
- Type 2 Diabetes
- 发起方
- University of Virginia
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Percent Time in Range
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
The purpose of this clinical trial is to test the safety and feasibility of using an Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration. Participants will be randomized to either the control group or the experimental group. If in the experimental group, the participant will use an insulin pump with Control-IQ Technology (Tandem Diabetes Care) for ten days. Researchers will compare the glycemic control of the experimental group to the control group.
详细描述
The study will involve 20 people with Type 2 Diabetes who are 18 years or older. The study will be performed at the University of Virginia (UVA), with screening procedures taking place either virtually or at the Clinical Research Unit (CRU) at UVA. All participants will undergo a 10-day run-in phase with a blinded Dexcom Generation 6 Continuous Glucose Monitor (CGM). Participants will be randomized (1:1) to either the Control (CTR) Group or the Experimental (EXP) Group. In the EXP Group, participants will use an Automated Insulin Device (AID) for 10 days in the Basal Insulin Titration (BIT) Phase then return to their original therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP). The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose. During the same 10 days, in the CTR group, participants will use an unblinded CGM and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. Both groups will then go into a 10-days maintenance period using a blinded CGM. Outcomes will be measured in the last 7 days of the BIT and Maintenance Phases.
研究者
Anas El Fathi
Principal Investigator
University of Virginia
入排标准
入选标准
- •Age ≥18.0 years old at time of consent.
- •Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year.
- •HbA1c ≥ 7.5%.
- •Currently using an approved long-acting insulin for at least two months (e.g., insulin glargine, insulin degludec)
- •If using a CGM, willingness to wear an additional study CGM during the duration of the study.
- •Access to the internet and willingness to upload data during the study as needed.
- •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 who self-report that they are 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 remain on same dose of non-insulin glucose-lowering agent during the trial (including metformin/biguanides, GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, sulfonylureas and naturaceuticals).
排除标准
- •Currently using an approved intermediate (e.g., insulin NPH) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro, insulin regular).
- •Currently being treated for a seizure disorder.
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:
- •Inpatient psychiatric treatment in the past 6 months
- •Presence of a known adrenal disorder
- •Uncontrolled thyroid disease
- •Currently pregnant or intent to become pregnant during the trial.
- •Currently breastfeeding.
- •Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.
- •History of hypoglycemia unawareness.
研究组 & 干预措施
Automated Insulin Delivery in the Basal Insulin Titration Phase
Participants will use Automated Insulin Delivery (AID) for 10 days in the Basal Insulin Titration (BIT) Phase. This group will then return to their original home therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP) with a blinded CGM. The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose.
干预措施: Control-IQ use in Type 2 Diabetes under basal insulin injections
Standard Care with Study Continuous Glucose Monitor
Participants will use a study Continuous Glucose Monitor (CGM) along with their original home therapy and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. This group will then transition into a 10-day Maintenance Phase (MP) using a blinded CGM, where the basal dose will be maintained.
结局指标
主要结局
Percent Time in Range
时间窗: 14 days
The percent of time spent within glycemic range of 70 to 180 mg/mL.
System Testing survey
时间窗: 14 days
Receiving feedback from the participants regarding system functionality.
次要结局
- Percent Time in Tighter Range(14 days)
- Percent Time Below Range(14 days)
- Mean glucose reading measured by Continuous Glucose Monitor (CGM)(14 days)
- Percent Time Above Range(14 days)
- Percent Time Below Range (Hypoglycemia)(14 days)
- Percent Time Above Range (Hyperglycemia)(14 days)