An Exploratory 16-Week Pilot Study of the Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin, With or Without Non-Insulin Antidiabetic Drugs, in Type 2 Diabetes Mellitus Participants Treated With Basal Insulin.
概览
- 阶段
- 不适用
- 干预措施
- Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs
- 疾病 / 适应症
- Type 2 Diabetes
- 发起方
- University of Virginia
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Time in Range 3.9-10.0 mmol/L (70-180 mg/dL)
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The goal of this clinical trial is to compare the effect of a continuous glucose monitor (CGM) based titration algorithm to standard titration by self-monitoring blood glucose (SMBG) in participants with Type 2 Diabetes already using long acting insulin. The comparison aims to study the difference in glycemic control between the two therapies. Participants will be followed for 18 weeks and will be provided with Degludec insulin, insulin pen, and a CGM (Dexcom G6).
详细描述
This is an 18-week study designed to investigate the effect of a continuous glucose monitor (CGM) based titration algorithm versus a standard titration by self-monitoring blood glucose (SMBG) on glycemic control in Type 2 Diabetes (T2DM) participants using insulin Degludec. After 2 weeks of blinded CGM baseline observation, participants are randomized 2:1 to CGM-based titration or standard titration by SMBG for 16 weeks. In the SMBG group, all titrated doses will be reviewed by a study physician prior to use and participants will wear a blinded CGM during the whole study. After completion of the 16-week titration, participants are followed up for 2 days. Participants will be divided related to use of sulfonylureas or glinides with a maximum cap of nine participants being treated with sulfonylureas and glinides to complete the study.
研究者
Marc Breton
Principal Investigator
University of Virginia
入排标准
入选标准
- •Age 18 years or older at signing of informed consent
- •Diagnosis of Type 2 Diabetes minimum 180 days before the day of screening
- •Hemoglobin A1c between 7-9% and measured by local lab at screening
- •On daily basal insulin for at least 90 days before inclusion into the study
- •Stable dose of oral and injectable (other than insulin) antidiabetic medications for 90 days prior inclusion. Acceptable medications include:
- •Sulfonylureas
- •Meglitinides (glinides)
- •Dipeptidyl peptidase 4 (DPP-4) inhibitors
- •Sodium glucose co-transporter 2 (SGLT2) inhibitors
- •Thiazolidinediones
排除标准
- •Hypersensitivity to Degludec
- •Use of an insulin pump
- •Use of a short-acting insulin
- •Participation or has participated in another trial within 90 days of the screening visit
- •Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method
- •Any disorder, except for conditions associated with T2D, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days of the screening visit
- •Known skin reactions to CGM adhesives
- •Current/prior use of CGM within 30 days of the screening visit
- •Any planned surgery or procedures where basal insulin would be decreased or held in anticipation
研究组 & 干预措施
Continuous Glucose Monitoring (CGM) based Titration
The CGM-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. For dose computation the algorithm is comprised of three components; titration glucose level, personalized target, and safety hypoglycemia feature.
干预措施: Continuous Glucose Monitoring (CGM)-based titration algorithm implemented in DiAs
Standard Self-Monitoring Blood Glucose (SMBG) Titration
The SMBG-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. Participants in the standard SMBG based titration group will wear a blinded CGM during the whole study. The total daily basal insulin dose will be converted 1:1 to Degludec. Algorithm informed dose changes will be made once weekly and checked by study physician.
结局指标
主要结局
Change in Time in Range 3.9-10.0 mmol/L (70-180 mg/dL)
时间窗: From baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)
Change in CGM-measured time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) from baseline to weeks 14-16, compared between control and experimental arm. change in TIR = TIR (weeks 14-16) - TIR (baseline). Change in TIR is measured with percentage points as TIR is measured with the percentage time spent within the range 3.9-10.0 mmol/L (70-180 mg/dL).
次要结局
- Change in HbA1c(From week 0 to week 16)
- Change in Mean Glucose Level(From baseline (week -2-0) to week 14-16)
- Percent Acceptance Rate(From week 0 to week 16)
- Change in Time in Tight Range 3.9-7.8 mmol/L (70-140 mg/dL)(From baseline (week -2-0) to week 14-16)
- Change in Time Above 10.0 mmol/L (180 mg/dL)(From baseline (week -2-0) to week 14-16)
- Change in Time Above 13.9 mmol/L (250 mg/dL)(From baseline (week -2-0) to week 14-16)
- Change in Continuous Glucose Monitoring Coefficient of Variation (%)(From baseline (week -2-0) to week 14-16)
- Change in Time Below 3.9 mmol/L (70 mg/dL)(From baseline (week -2-0) to week 14-16)
- Change in Time Below 3.0 mmol/L (54 mg/dL)(From baseline (week -2-0) to week 14-16)
- Basal Insulin Dose Changes(From week 0 to week 16)