Real World Evaluation of Advisor Pro in Clinical Practice
To assess the integration of the DreaMed Advisor Pro tool into a real-world clinical practice using both in person and virtual visits to assess benefits in glycemia, as measured by the glucose management indicator and other glucose metrics.
To determine acceptability of the DreaMed Advisor Pro tool both from a person with diabetes as well as a health care provider perspective.
To quantify the potential reimbursement potential that could be generated with use of the DreaMed Advisor Pro.
調査の概要
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:
- Participant with Type 1 diabetes
- Age ≥ 6 years to <30 years
Using Insulin infusion pump (CSII) therapy including those with low glucose suspend and predictive low glucose suspend features
- Insulin pump must not use automated insulin delivery (closed loop, artificial pancreas)
- Total daily dose of insulin must be greater than 0.5 units/kg/day
- Participants / parents are required to have minimum computer skills and access to a computer in order to upload their personal devices (Pump, BG meter etc) to Tidepool.
- Participants using Dexcom sensors will allow access to their account for the study duration
- Participants not using CGM must agree to test BG at least 4 times a day at appropriate intervals
- Participants / parents will have to have a smartphone (Apple or Android and Windows)
Exclusion Criteria:
- An episode of diabetic ketoacidosis within the month prior to study entry
- Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety,
- Current participation in any other interventional study
- Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
- Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine Society
- Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
- Participants suffers from an eating disorder
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：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：DreaMed Advisor Pro tool used for insulin optimization
|
Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data consisting of glucose levels, insulin delivery history and meal consumption reported
|
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 |
|---|---|---|
|
Change in glucose control with the use of DreaMed
時間枠：6 months
|
Glucose mangement indicator (GMI) will be used to determine glucose control.
The GMI indicates the average A1C level that would be expected based on mean glucose measured in a large number of individuals with diabetes.
Mean glucose ideally is derived from at least 14 days of CGM data
|
6 months
|
協力者と研究者
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。