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治験 NCT06572306（対象：2型糖尿病）は募集中です。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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南フロリダ大学Pharmacist-led Continuous Glucose Monitoring 20
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 NCT06572306 は 観察研究 臨床試験 で、2型糖尿病 に関するものです。現在は 募集中 で、2024年9月1日 から開始しています。20 名の参加者 の募集が計画されています。この試験は 南フロリダ大学 によって主導され、2025年8月5日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年8月28日 です。
概要
This is a pilot study. The goal of this prospective cohort study is to determine impact of pharmacist-led continuous glucose monitoring on glycemic control and health behavior change in people with type 2 diabetes. The main questions it aims to answer are:
- to assess change in hemoglobin A1c in people with type 2 diabetes using continuous glucose monitoring under a pharmacist-led approach as compared to a pharmaci...
公式タイトル
Investigating the Impact of Pharmacist-led Flash Continuous Glucose Monitoring on Clinical and Behavioral Health Outcomes
疾患名
2型糖尿病刊行物
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
- STUDY007451
NCT番号
開始日
2024-09-01
最終更新日
2024-08-28
終了予定日
2025-08-05
目標参加者数
20
試験の種類
観察研究
状況
募集中
キーワード
type 2 diabetes
endocrine disorders
continuous glucose monitor
pharmacist
endocrine disorders
continuous glucose monitor
pharmacist
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Continuous glucose monitoring cohort (intervention) Freestyle libre 2 sensor devices will be used to monitor glucose. The sensors are worn on the upper arm and changed every 14 days. Each subject will have 5 visits with a pharmacist over 12 weeks. Subjects meeting inclusion criteria will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8%. Subjects must have a compatible smartphone with the freestyle libre 2 sensor system. Subjects must have...もっと見る | FreeStyle Libre 2 Continuous Glucose Monitor Subjects included in the intervention group (continuous glucose monitoring) will be recruited from the USF Health Department of Family Medicine. Each subject will be enrolled for 12 weeks. |
Self-monitoring of blood glucose cohort (historical cohort) A retrospective chart review will be performed on patients seen by a clinic pharmacist between 1/1/2020-7/1/2024. Subjects in this group will include adults ≥18 years of age with type 2 diabetes and a hemoglobin A1c ≥ 8% and using a glucometer to monitor blood sugar. Exclusion criteria will be use of any continuous glucose monitoring device within the prior 6 months of the index date (defined as first visit with a ph...もっと見る | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in hemoglobin A1c | Between-group difference in change in hemoglobin A1c at 12 weeks, %, compared between intervention and historical cohort | Baseline to End of Study (12 weeks) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Time in Range | Change in the time in range (70-180 mg/dL) at 12 weeks, %, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
Mean Sensor Glucose | Change in mean sensor glucose concentration at 12 weeks, mg/dL, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
Time Below Range | Change in time below range (\< 54mg/dL and \< 70 mg/dL) at 12 weeks, %, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
Time Above Range | Change in time above range (\> 180 mg/dL and \> 250 mg/dL) at 12 weeks, %, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
Glycemic Variability | Change in glycemic variability (standard deviation, and Coefficient of variance) at 12 weeks, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
Time in Range Increase 5% | Change in the number of subjects increasing 5% or more in time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
Time in Range Increase 10% | Change in the number of subjects increasing 10% or more in time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
>70% Time in Range | Change in the number of subjects achieving \> 70% time in range (70-180 mg/dL) at 12 weeks, compared within the intervention cohort | Baseline to End of Study (12 weeks) |
Hemoglobin A1c <7% | Change in the number of subjects achieving hemoglobin A1c \< 7% at 12 weeks compared between intervention and historical cohort | Baseline to End of Study (12 weeks) |
Hemoglobin A1c <8% | Change in the number of subjects achieving hemoglobin A1c \< 8% at 12 weeks compared between intervention and historical cohort | Baseline to End of Study (12 weeks) |
Summary of Diabetes Self-Care Activities Measure | Change in the Summary of Diabetes Self-Care Activities Measure at 12 weeks, compared within the intervention group. Scored on an 8-point likert scale (0-7). Higher scores indicate better compliance with diabetes self-care, whereas a lower score indicate poor self-care performance. | Baseline to End of Study (12 weeks) |
Continuous Glucose Monitoring Survey Responses | Change in survey responses at 12 weeks, compared within the intervention group | Baseline to End of Study (12 weeks) |
参加アシスタント
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
- type 2 diabetes
- hemoglobin A1c ≥ 8%
- compatible smartphone with FreeStyle Libre 2 continuous glucose monitoring system
- current use and access to a glucometer for self-monitoring of blood glucose
- any continuous glucose monitor use within 6 months prior to study enrollment
- pregnant and planning to become pregnant during study time frame
- history of hypoglycemia requiring third party assistance
- history of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to study enrollment
- known allergy to medical grade adhesives
- current use of systemic steroids for any medical condition
- current use of dialysis
南フロリダ大学101 件のアクティブな治験を探索責任者
Kevin Cowart, 主任研究者, Assistant Professor, University of South Florida
試験中央連絡先
連絡先: Kevin Cowart, PharmD, MPH, 813-974-5562, [email protected]
2 1カ国の場所
Florida
USF Health Department of Family Medicine - Morsani Center for Advanced Health Care, Tampa, Florida, 33612, United States
Kevin Cowart, PharmD, MPH, 連絡先, 813-974-5562, [email protected]
募集中
USF Health Department of Family Medicine - University Partnership Center, Tampa, Florida, 33613, United States
Kevin Cowart, PharmD, MPH, 連絡先, 813-974-5562, [email protected]
募集中