Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
調査の概要
詳細な説明
Screening & End of 3-Week Run-in Period (Visit 1, Week 0) : Screening will be conducted by invitation to potentially eligible subjects. The study will be explained and written informed consent will be obtained from parents or patients (when 18 years of age or older) prior to conducting any study-related procedures. After written informed consent and patient assent (when <18 years of age) have been obtained, potential participants will undergo a history and physical exam. Girls of childbearing potential will have a urine pregnancy test performed at the time of the enrollment visit and the need for contraception for the entire duration of the study will be discussed. At this and all other study visits, participants/parents will meet with a diabetes care provider (i.e., a physician, nurse practitioner, or physician assistant) who will carry out a comprehensive review of diabetes management and review blood glucose and ketone records. The treatment regimen will be adjusted as clinically indicated during the initial screening visit and baseline data (including CGM and insulin dose data) will be collected in all participants during the 3-week run-in period of the study; HbA1c levels will be measured at the end of the 3-week baseline period in all eligible participants.
Baseline data obtained at the screening or 3-week baseline visit will include:
- Demographic characteristics, including family income, highest parental education attained, and number of individuals in the home
- 3-week data regarding CGM, insulin dose and Fitbit data
- Anthropometric measures (height, weight, BMI, vital signs) and physical exam
- Current diabetes care practices (frequency of self-monitored blood glucose (SMBG), insulin dosing, review of blood glucose values)
- Medical History: duration of diabetes, comorbidities, past medical history, social history, family history, medications, and allergies
- Additional diabetes history including current/past use of CGM, insulin pump, and other modes of diabetes technology
- Frequency of Emergency Department visits due to decompensated diabetes (i.e., hyperglycemia, ketosis and DKA) over the past 6 months
- Baseline laboratory assessment including lipid panel and urine microalbumin
Psychosocial Questionnaires will be administered
- Hypoglycemia Fear Survey (parent and child)
- Pittsburgh Sleep Quality Index
- Diabetes Treatment Satisfaction Questionnaire (DTSQ, DTSQc), which includes eight items, six of which form a scale (scored 0-36) in which higher scores indicate greater treatment satisfaction
- Diabetes-specific emotional distress using Problem Areas in Diabetes scale
After collection of all baseline data, eligible participants will be randomized to either the control or intervention group and receive instructions for the study. Participants will also be provided with a FitBit and instructed to wear this for the duration of the study to track activity levels. Participants in the intervention group will be required to upload their diabetes devices to Tidepool each week for the duration of the study. Tidepool is program used at Yale Pediatric Diabetes clinics as the current standard of care for uploading devices (pumps, CGMs, Bluetooth enabled pens) in our clinics and is HIPAA compliant. Participants may contact the Yale Diabetes Team for insulin dose adjustments or the study team at any point during the study if they have a question about the study.
Visit 2 (Week 13) & Visit 3 (Week 26): At these visits, all participants will meet with a diabetes care provider who will carry out a comprehensive review of diabetes management and review blood glucose and insulin records. Diabetes devices will be downloaded, and glycemic trends and insulin dosing regimens will be reviewed. The treatment regimen will be adjusted as clinically indicated.
After 26 weeks in the study, intervention group parents will be asked to participate in focus groups to discuss the study. These meetings will take place at the Yale Pediatric Diabetes Research Center.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
i. Clinical diagnosis of type 1 diabetes for at least 1 year ii. Ages 7-21 years iii. Participants 18 years of age must be able to read and provide written consent iv. Participants under 18 years of age must be able to read and provide written assent v. Participants are managed using an insulin pump or multiple daily injections vi. Participant has a CGM or is willing to wear a CGM for the duration of the study
Exclusion Criteria:
I. Hemoglobin A1c <7.5% or > 10.0% ii. Recent history of more than 1 episode of diabetic ketoacidosis (DKA) in the past 4 months iii. Treatment with glucose lowering drugs other than insulin iv. Females who are pregnant, lactating, or planning to become pregnant in the next 6 months v. Another medical condition that precludes participation in the study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Automated Insulin Dose Adjustment (AIDA)
Using the AIDA system to assist the parents of children with T1D make insulin dose adjustments
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The system originally developed at Boston Children's Hospital, obtains CGM, insulin delivery, and activity data, from the cloud each day at approximately 8:00 PM using an Application Program Interface (API) calls to commercial companies (primarily Glooko and Tidepool) that aggregate data from different devices used to manage glucose levels in individuals.
A detailed statistical and control analysis (see preliminary data study 1 for algorithm details) of the data are then conducted to determine if a change in therapy is required.
If the analysis indicates a change in therapy is required, the patient or parent is notified by text or email directing then to a web portal detailing the change.
The patient or parent can accept or modify the recommended change.
If a change is made, the AIDA system confirms that the change is correctly implemented into the patient's pump or Bluetooth enabled pen when the patient next uploads the device data to the cloud.
|
|
アクティブコンパレータ：Control
Standard Care - change in therapy settings effected a regularly scheduled patients visits
|
Standard Care - change in therapy settings effected at regularly scheduled patient visits
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent of patients at target range from baseline to 13 week
時間枠：13 weeks
|
Based on continuous glucose monitoring.
Target range is defined as 70- 180 mg/dL
|
13 weeks
|
|
Percent of patients at target range from baseline to 26 weeks
時間枠：26 weeks
|
Based on continuous glucose monitoring.
Target range is defined as 70- 180 mg/dL
|
26 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in HbA1c
時間枠：13 weeks
|
This outcome will determine if there was a change in HbA1c levels from baseline to 13 weeks based on continuous glucose monitoring
|
13 weeks
|
|
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
時間枠：Baseline
|
Based on continuous glucose monitoring
|
Baseline
|
|
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
時間枠：13 week
|
Based on continuous glucose monitoring
|
13 week
|
|
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
時間枠：26 week
|
Based on continuous glucose monitoring
|
26 week
|
|
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
時間枠：Baseline
|
Frequency of nighttime hypoglycemic events
|
Baseline
|
|
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
時間枠：13 week
|
Frequency of nighttime hypoglycemic events
|
13 week
|
|
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
時間枠：26 week
|
Frequency of nighttime hypoglycemic events
|
26 week
|
|
Percent of the recommendations that are accepted or modified by the family
時間枠：26 week
|
Percent of the recommendations that are accepted or modified by the family
|
26 week
|
|
Hypoglycemia Fear Survey
時間枠：26 weeks
|
This will be administered to the child and parent.
The survey consists of 23 questions.
Questions are answered using a 5 point likert scale ranging from never, rarely, sometimes, often, and always.
The administration time is 10 minutes.
The higher scores entail greater worry.
|
26 weeks
|
|
Pittsburgh Sleep Quality Survey (PSQI)
時間枠：26 weeks
|
The survey consists of 10 questions.
The Questions relate to usual sleep habits over the last month, including time it takes to fall asleep, usual bedtime, hours of sleep per night, as well as questions about the frequency of sleep issues (not during the past month, less than once per week, once or twice per week, or three or more times per week).
Higher scores suggest poorer sleep quality.
The administration time is 5 minutes.
|
26 weeks
|
|
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
時間枠：26 weeks
|
This will be administered to the parent and teen.
The survey consists of 12-24 questions that are based on a likert scale ranging from 0 to 6. Higher scores entail greater satisfaction.
The administration time is 10 minutes.
|
26 weeks
|
|
Problem Areas in Diabetes Scale (PAID)
時間枠：26 weeks
|
This is a questionnaire with 20 questions scaled from 0 to 4 on a likert scale.
Questions involve feelings and emotional distress related to diabetes.
Higher scores entail a more serious problem related to diabetes.
The Administration time is 5 minutes.
|
26 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Laura Nally, MD、Yale University
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2000027002
- 2K12DK094714-06 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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