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治験 NCT05420714（対象：糖尿病）は撤回です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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テキサス大学南西部医学センターProfessional Continuous Glucose Monitoring at the Parkland Diabetes Clinic 短期
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05420714 は 介入研究 臨床試験 で、糖尿病 に関するものです。現在は 撤回 で、2022年8月1日 から開始しています。該当なし 名の参加者 の募集が計画されています。この試験は テキサス大学南西部医学センター によって主導され、2023年9月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2022年7月6日 です。
概要
The purpose of this study is to assess whether the short-term use of professional continuous glucose monitoring (Pro-CGM) at the Parkland Diabetes Clinic in selected patients with poorly-controlled diabetes due to hyper- and/or hypoglycemia leads to improvements in patients' glycemic control within 3-6 months, subjective understanding of how food, activity, and medications affect blood sugar levels, and diabetes self...もっと見る
公式タイトル
Piloting the Use of Professional Continuous Glucose Monitoring at the Parkland Diabetes Clinic
疾患名
糖尿病刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- STU-2021-1012
NCT番号
開始日
2022-08
最終更新日
2022-07-06
終了予定日
2023-09
試験の種類
介入研究
治験の相・段階
該当なし
状況
撤回
キーワード
continuous glucose monitoring
主目的
医療サービス研究
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Professional CGM Trial Participants will be asked to wear Dexcom Professional Continuous Glucose Monitoring (Pro-CGM) Device for 10 days. They will have 2 clinic visits with a certified diabetes care and education specialist (CDCES): initial visit for placement of the Pro-CGM and final visit to review the data with CDCES and their diabetes clinic provider. They will be asked to complete a short survey at the end of the 10 days about their ...もっと見る | Dexcom Professional Continuous Glucose Monitoring Patient will be asked to wear the Dexcom Pro-CGM device (small device that can be applied to either the arm or abdomen) for 10 days. They will have 30 minutes initial visit with CDCES to apply the device and review its use and 60 minute final session to review the blood sugar data from the CGM with CDCES and diabetes clinic provider. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Average change in glycemic control 3 months after Pro-CGM use | Glycemic control will be assessed at baseline and 3 months after intervention by measuring hemoglobin A1c and/or obtaining 14-day average glucose from glucometer or CGM blood sugar data download. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review. | 3 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Average change in hypoglycemia frequency 3 months after Pro-CGM use | Hypoglycemia frequency will be assessed at baseline and 3 months after intervention by reviewing 14-day fingerstick glucose data from glucometer download and comparing the % of blood sugar reading \<70 mg/dL at baseline and 3 months after intervention. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review. | 3 months |
Average change in hyperglycemia frequency 3 months after Pro-CGM use | Hyperglycemia frequency will be assessed at baseline and 3 months after intervention by reviewing 14-day fingerstick glucose data from glucometer download and comparing the % of blood sugar reading \>180 mg/dL at baseline and 3 months after intervention. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review. | 3 months |
Average change in frequency of fingerstick blood glucose checks 3 months after Pro-CGM use | The frequency of fingerstick glucose checks per day will be obtained from glucometer data download, which provides the average # of blood sugar reading per day, at baseline and 3 months after intervention. These data are collected as part of routine diabetes care at the clinic and will be obtained by chart review. | 3 months |
Percentage of positive patient response to the Pro-CGM Questionnaire | The patients are given a questionnaire with 8 "Yes or No" questions about whether or not wearing the CGM has a positive impact on their diabetes self-care practices (diet, exercise, medication adherence, blood glucose monitoring). The percentage of "Yes" responses for the 8 questions will be calculated. | The survey will be administered at the end of the 10 days Pro-CGM use. The percentage of positive responses will be calculated at the end of study. |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
Patients of the Parkland Diabetes Clinic who meets one or more of the following criteria:
- Patients with inaccurate HgbA1c due to conditions that affect red blood cell turnover (examples include but not limited to: anemia, hemoglobinopathies, chronic kidney disease)
- Patients with suspected recurrent hypoglycemia and/or hypoglycemia unawareness
- Patients with persistently elevated HgbA1c >8% despite reported adherence to medications and lifestyle modifications and after assessment by a Certified Diabetes Care and Education Specialist (CDCES)
- Patients with inability to do frequent fingersticks for blood glucose checks due to physical limitations (examples include but not limited to: vision loss, dexterity problems)
- Patients who already have their own personal continuous glucose monitoring device
テキサス大学南西部医学センター284 件のアクティブな治験を探索責任者
Felona Gunawan, 主任研究者, Assistant Professor, University of Texas Southwestern Medical Center
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位置情報がありません。