Wireless Innovation for Seniors With Diabetes Mellitus (WISDM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 42
- 主要终点
- Time spent with glucose level <70 mg/dL
研究概览
简要总结
The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve quality of life in older adults with T1D.
详细描述
Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve quality of life including reducing hypoglycemic fear and diabetes distress. Despite these potential benefits, CGM is used by only a small proportion of older adults with T1D. Previous studies assessing CGM efficacy have included only a small number of adults ≥ 60 years of age, excluded patients most prone to severe hypoglycemia, focused on improving HbA1c rather than hypoglycemia, and used older generation CGM sensors. These studies are not generalizable to the population of older adults with T1D. The potential benefit of CGM in reducing hypoglycemia in the older adult population has not been well studied. The goal of this study is to assess the potential benefits and risks of CGM in older adults with T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible for the study, all participants must meet the following criteria:
- •Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator and meeting at least one of the following criteria:
- •i. Age > 6 months and < 10 years old at diagnosis OR ii. Positive pancreatic autoantibodies at any time (GAD-65, IA-2, ICA or ZnT8) or positive anti-insulin autoantibody at diagnosis only (within 10 days of starting insulin) OR iii. Presence of 2 or more of the following clinical indicators suggestive of type 1 diabetes:
- •Age at diagnosis < 40 years
- •Non-obese at diagnosis according to BMI (< 95th percentile pediatric and < 30 kg/m2 adult)
- •Diabetic ketoacidosis (DKA) at any time,
- •Plasma C-peptide level < 0.8 ng/ml (with blood glucose > 80 mg/dL if available) at any time
- •Family history of type 1 diabetes in a first degree relative (parent, sibling, or child).
- •Age ≥60 years
- •HbA1c <10.0% at screening or within 30 days prior to screening visit (the upper limit was selected as a surrogate measure of likelihood of adherence to the protocol with the belief that those with higher HbA1c levels are generally noncompliant with diabetes management and thus not good candidates for the trial)
- •Insulin regimen involves either use of an insulin pump (a minimum of 40% of study population) or multiple daily injections of insulin (minimum of 40% of study population).
- •Participant is able to manage his/her diabetes with respect to insulin administration and glucose monitoring (which may include assistance from spouse or other caregiver)
- •Participant understands the study protocol and agrees to comply with it
- •Participant comprehends written and spoken English
- •At least 240 hours (10 out of 14 days) of sensor glucose data with appropriate number of calibrations from the blinded CGM pre-randomization phase
排除标准
- •Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation.
- •Use of unblinded CGM, outside of a research study, as part of real-time diabetes management in the last 3 months
- •At least 10% of time spent with sensor glucose levels < 54 mg/dl during the blinded CGM screening period AND a severe hypoglycemic event in the past 6 months (a severe hypoglycemic event that required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions (see section 8.1).
- •Extreme visual or hearing impairment that would impair ability to use real-time CGM assessed at screening visit
- •Known adhesive allergy or skin reaction during the blinded CGM pre-randomization phase that would preclude participation in the randomized trial
- •Plans to begin non-insulin medication for blood glucose lowering during the course of the study
- •Stage 4 or 5 renal disease or most recent GFR < 30 ml/min/m2 from local lab within the past 6 months
- •The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of <1 year.
- •Clinical diagnosis of dementia (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)
- •Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial (unless stipulation no longer required with use of newer generation sensors)
- •Inpatient psychiatric treatment in the past 6 months
- •Participation in an intervention study (including psychological studies) in past 6 weeks.
- •Expectation that participant will be moving out of the area of the clinical center during the next 6 months, unless the move will be to an area served by another study center.
研究组 & 干预措施
Continuous Glucose Monitor group
CGM group participants will be asked to use a Dexcom CGM sensor on a daily basis, inserting a new sensor as needed. Participants will be instructed to use the sensor according to FDA labeling. In addition, participants will be advised to check the blood glucose when symptoms or expectations do not match the CGM reading. Participants will have clinic visits at 10 days, 4 weeks, 8 weeks, 16 weeks, and 26 weeks.
干预措施: Dexcom CGM (Device)
Blood Glucose Meter group
BGM group participants will be asked to use a study blood glucose meter with test strips for a fingerstick blood glucose check with a recommendation of 4 times a day. Participants will be permitted to check a fingerstick glucose as many times a day as they choose. Participants will have a phone visits at 10 days and clinic visits at 4 weeks, 8 weeks, 16 weeks, and 26 weeks. In addition to the in-clinic study visits, the BGM group will have blinded sensor placement visits one week prior to each of the 8, 16, and 26 week visits.
结局指标
主要结局
Time spent with glucose level <70 mg/dL
时间窗: 6 months (26 weeks) from baseline
The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (\<70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analysis.
次要结局
- Change in QOL: NIH Cognitive Toolbox(6 months (26 weeks) from baseline)
- Change in QOL: Preferring Hypoglycemia Scale(6 months (26 weeks) from baseline)
- Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire(6 months (26 weeks) from baseline)
- Change in QOL: PROMIS Measures for QOL(6 months (26 weeks) from baseline)
- Time spent with glucose level <60 mg/dL(6 months (26 weeks) from baseline)
- Time spent with glucose level <54 mg/dL(6 months (26 weeks) from baseline)
- Change in QOL: NIH Emotions Toolbox(6 months (26 weeks) from baseline)
- Change in HbA1c(6 months (26 weeks) from baseline)
- Change in QOL: Hypoglycemia Fear Survey(6 months (26 weeks) from baseline)
- Change in QOL: Diabetes Distress Questionnaire(6 months (26 weeks) from baseline)