FAM (Follower, Action Plan, and Remote Monitoring) Intervention to Reduce Severe Hyperglycemia in Adults With Type 1 Diabetes Mellitus at Risk for Diabetic Ketoacidosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- percentage of time with severe hyperglycemia
研究概览
简要总结
Diabetic ketoacidosis (DKA) results in significant morbidity and healthcare utilization and is the main contributor to loss of life expectancy in people with diabetes mellitus type 1 (T1DM) <50 years old. This suggests the need to develop interventions to reduce DKA events. Innovative features of newer continuous glucose monitoring devices offer opportunities for novel strategies to reduce DKA. Designating a family member, friend, or caregiver as a Follower was associated with reduction in HbA1C, increased time in range, and improvement in quality of life metrics in people with T1DM. However, the previously published studies are limited as they were either retrospective, survey-based, or do not overlap with our proposed cohort involving adults ages 18-65 with T1DM (prior prospective studies involved either pregnant women with T1DM or adults ≥60 years of age with T1DM). This study is a randomized controlled trial pilot study to evaluate an intervention (FAM) using a Follower, Action Plan, and Remote Monitoring of glucose data to reduce severe hyperglycemia, a modifiable risk factor for DKA, in adults with T1DM at high risk for DKA. The intervention uses real-time glucose data sharing with a Follower (family member, friend, or caregiver) and personalized diabetes education provided to the dyad (person with T1DM and their chosen Follower). The overall hypothesis is that the FAM intervention will improve glycemia with the primary outcome studied in this preliminary pilot study being percentage of time spent with glucose ≥250 mg/dL.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with T1DM for ≥1 year ages 18 - 65
- •HbA1C ≥7.5.0% - 14.0%
- •If the person with T1DM uses a CGM, the CGM must have the capability of real-time data sharing including glycemic alerts with a Follower (including but not limited to Dexcom G6 or G7 or FreeStyle Libre 2 or 3, or Medtronic Guardian Sensor 3)
- •Follower (family member or friend ages 18 years and older) willing to participate in the study and "follow" glucose data and who was no self-reported cognitive impairment
- •Ability of the dyad (participant and Follower) to communicate and provide consent in English
- •CGM users: ≥50% personal CGM use and ≥50% Dexcom G6 Pro CGM use during the pre-intervention period (days -14 to -1)
- •Non CGM users: ≥50% Dexcom G6 Pro CGM use and average ≥2 BGM readings/day during the pre-intervention period (days -14 to -1)
排除标准
- •Active treatment with a sodium-glucose cotransporter-2 inhibitor or planning to start a sodium-glucose cotransporter-2 inhibitor in the next 6 months
- •Active malignancy with the exception of non-melanoma skin cancer
- •Skin conditions that inhibit wearing a CGM sensor and known severe allergy to adhesives
研究组 & 干预措施
control group
anticipate 8 CGM and 2 non-CGM user dyads in the control group
干预措施: FAM intervention consisting of a Follower of glucose data, Action Plan, and Remote Monitoring of glucose data (Device)
intervention group
anticipate 8 CGM and 2 non-CGM user dyads in the intervention group
干预措施: standard of care (Other)
结局指标
主要结局
percentage of time with severe hyperglycemia
时间窗: 90 days
number of continuous glucose monitoring or blood glucose monitoring readings with glucose ≥250 mg/dL divided by the total number of readings
次要结局
- Hyperglycemia - Continuous Glucose Monitor glucose monitor (CGM) metrics(90 days)
- Glycemic variability - Continuous Glucose Monitor(90 days)
- Level 2 Hypoglycemia - Continuous Glucose Monitor(90 days)
- Severe hyperglycemia >400 mg/dL - Continuous Glucose Monitor glucose monitor (CGM) metrics(90 days)
- Hypoglycemia - continuous glucose monitor(90 days)
- Hemoglobin A1c(days 0 and 90)
- Time in Range - Continuous Glucose Monitor(90 days)
- Number of glucose reading/day - Blood Glucose Monitor(90 days)
- Glucose Management Indicator - Continuous Glucose Monitor(90 days)
- Level 2 Hypoglycemia -Blood Glucose Monitor(90 days)
- Assessment of the intervention's efficacy and its burden on participants(90 days)
- Hyperglycemia - Blood Glucose Monitor(90 days)
- Severe Hyperglycemia > 400 mg/dL - Blood Glucose Monitor(90 days)
- Hypoglycemia - Blood Glucose Monitor(90 days)
- Time in Range - Blood Glucose Monitor(90 days)
- Ketone assessment(90 days)
- Hypoglycemic Confidence Scale(90 days)
- Diabetes Distress Scale for Adults with T1DM(90 days)
- Diabetes Empowerment Scale(90 days)
- 36-Item Short-Form Health Survey(90 days)
- Hypoglycemic Confidence Scale for Partners of Adults with T1DM(90 days)
- Diabetes Distress Scale for Partners of Adults with T1DM(90 days)