CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Family Communication Inventory Questionnaire
研究概览
简要总结
This study is to assess an approach of self-management called CloudConnect, evaluating the impact of CloudConnect Reports on patient engagement, adolescent/parent discussion, and clinical outcomes in adolescent Type 1 Diabetes (T1D).
详细描述
It is hypothesized that in contrast to adolescents randomized to the Control Group subjects will maintain a Hemoglobin A1c (HbA1c) while adolescents randomized to receiving the CloudConnect Report will have a lowering of HbA1c that is related to the increase in adolescent/parent disease-specific engagement. Moreover, the hypothesis is that the subjects receiving the CloudConnect Report will increase the engagement of adolescents/ parent through increased communication and self-management behavior, and that this increase in engagement will lead to improved medical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to provide informed consent
- •Adolescents ages ≥12 and ≤ 17 years old with a parent/guardian (18+ yo) who is willing to participate with the child
- •HbA1c ≥7 and ≤ 11 % (point-of-care machine or local laboratory [i.e. LabCorp]) (*This criteria only applies to the Main Study, it does not apply to the Pilot Study*)
- •Willingness and ability to comply with scheduled visits and study procedures
- •Willingness to comply with all the study devices during the entire trial (i.e. commercially-available CGM, Fitbit, Companion Medical inPen)
- •One month stability on insulin parameters prior to enrollment
- •MDI users should use Humalog® and Novolog® insulin to use in study insulin pen
- •Type 1 diabetes mellitus diagnosed at least one year prior to enrollment in the study as noted by the following:
- •Criteria for documented hyperglycemia (at least 1 criterion must be met):
- •Fasting glucose ≥ 126mg/dL-confirmed
- •Two-hour Oral Glucose Tolerance Test (OGTT) ≥200mg/dL-confirmed hemoglobin A1c (HbA1c) ≥6.5% and documented by history - confirmed Random glucose ≥200 mg/dL with symptoms
- •No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- •Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):
- •Participant required insulin at diagnosis and continually thereafter
- •Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually)
- •The diagnosis of type 1 diabetes mellitus does not require documentation of C-peptide level or islet cell antibody positivity.
- •Commitment to maintaining uninterrupted availability via cell phone at all times
- •No diabetes complications
- •Participants must demonstrate English proficiency and proper mental status and cognition for completion of the study.
- •Not currently known to be pregnant, breast feeding, or intending to become pregnant (females). A negative urine pregnancy test will be required for adolescent girls who are able to become pregnant. Participants who become pregnant will be discontinued from the study.
- •Ability to access the Internet to provide data to the clinical team or to travel to the research center so that the study equipment can be downloaded.
- •Medication stability in the preceding two months if taking antihypertensive, thyroid, anti-depressant or lipid lowering medication.
排除标准
- •Children outside the ages of 12-17 y.o. or those who do not have a parent/guardian willing to participate
- •Diabetic ketoacidosis in the past 6 months
- •Pregnancy, breast-feeding, or intention of becoming pregnant
- •Current or recent alcohol or drug abuse by patient history
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding, cooperation, or ability to fill out questionnaires.
- •Any skin condition that prevents sensor placement (e.g., bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
- •Psychiatric disorders that would interfere with study tasks (e.g. cognitive disability, psychiatric hospitalization within 12 months)
- •Use of acetaminophen (*this criteria only applies when the CGM version being used is older than the G6*)
- •Use of long-acting insulin that is not Lantus or Tresiba
- •For subjects who currently use a close-loop insulin pump and CGM: not being willing to turn off the closed-loop function
- •Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility)
- •Cystic fibrosis
- •Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- •Any other comorbidity that at the judgment of the investigator may interfere with the participation on the study (i.e. uncontrolled high blood pressure or thyroid disease, current diabetic microvascular complications, current diagnose of gastroparesis)
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- •Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the Dexcom CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
- •Active enrollment in another clinical trial
- •No eligiblity criteria is required for parent(s)/guardian(s) other than the legal relationship and 18+ yo.
- •List any restrictions on use of other drugs or treatments.
- •o Use of anti-diabetic agents other than short-acting insulin for CSII subjects or long-acting insulin for MDI subjects, including: metformin, sulfonylureas, meglitinides, thiazolidinediones, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 agonists and alpha-glucosidase inhibitors
结局指标
主要结局
Family Communication Inventory Questionnaire
时间窗: 12-weeks
It is hypothesized that individuals randomized to the Control Group will initially modestly improve management as a result of either of new access to CGM, but it will return to baseline levels by the 12-week evaluation. By contrast, it is hypothesize that individuals randomized to the Experimental Group will benefit from receiving the weekly CloudConnect Report by having increased engagement and communication by 8 weeks that is sustained by 12 weeks (3 months). The communication will be measured by comparing pre- and post-study Family Communication Inventory questionnaire and the weekly communication assessments. The Family Communication Inventory, Frequency scale assesses the amount of times a parent and adolescent communicate regarding insulin dosing. Scores range from 0 to 36, with higher scores reflecting more frequent communication--commonly thought of as a better outcome.
次要结局
- Family Conflict Scale(12-week)
- Child Self Management Score(12-week)
- Change of Insulin Parameters(12-week)
- Low Blood Glucose Episodes Per Week(12-week)
- Weekly Diabetes Communication(12-week)
- Glucose Time in Range 70-180 mg/dL, Overall(Overall (12 weeks))
- HbA1c, Final(12-week)
- Division of Diabetes Responsibilities Score(12-week)
- Mean Glucose by CGM(12-week)
- Percent Time <70 mg/dL(12-week)
- Percent Time >180 mg/dL(12-week)
- My-Q(12-week)
- Tone of Response(12-week)
研究者
Mark D. DeBoer, MD, MSc., MCR
Principal Investigator
University of Virginia