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治験 NCT05222815 (GluCoCare)（対象：2型糖尿病）は実施中／登録終了です。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。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Glucose Monitoring Comparison in Primary Care (GluCoCare) 360 無作為化
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 NCT05222815 (GluCoCare) は 介入研究 臨床試験 で、2型糖尿病 に関するものです。現在は 実施中／登録終了 で、2022年8月29日 から開始しています。360 名の参加者 の募集が計画されています。この試験は HealthPartners Institute によって主導され、2026年2月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月5日 です。
概要
This research trial will randomize 50 primary care clinics and 354 patients in accordance with their primary care clinic assignment to 2 different glucose monitoring strategies (SMBG vs. CGM) and compare the effectiveness through a pragmatic clinic cluster randomized design, with active glycemic management in a "usual" primary care setting, over the course of a 12 month active study period.
詳細説明
The trial will evaluate the comparative effectiveness of SMBG (self-monitoring of blood glucose, also known as blood glucose monitoring \[BGM\] or fingerstick blood glucose monitoring) vs. continuous glucose monitoring (CGM), in managing glucose levels in individuals with type 2 diabetes (T2D) using insulin, with or without other glycemic therapies, in a primary care setting.
The study will use a 2-arm, parallel gro...
もっと見る公式タイトル
Comparing Fingerstick Blood Glucose Monitoring Versus Continuous Glucose Monitoring in Primary Care
疾患名
2型糖尿病その他の研究識別子
- GluCoCare
- 19-326
NCT番号
開始日
2022-08-29
最終更新日
2026-01-05
終了予定日
2026-02
目標参加者数
360
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
Type 2 Diabetes
Continuous Glucose Monitor
Blood Glucose Monitor
Self-Monitoring of Blood Glucose
Primary Care
Glycemic Control
Time In Range
Diabetes Distress
Insulin
A1C
Glucose Management
Comparative effectiveness
Continuous Glucose Monitor
Blood Glucose Monitor
Self-Monitoring of Blood Glucose
Primary Care
Glycemic Control
Time In Range
Diabetes Distress
Insulin
A1C
Glucose Management
Comparative effectiveness
主目的
治療
割付方法
無作為化
介入モデル
並行割当
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CGM (continuous glucose monitoring) Use CGM, with availability of Ambulatory Glucose Profile (AGP) data, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources. | CGM Continuous glucose monitor (CGM)-based glucose monitoring |
実薬対照薬SMBG (Self-monitoring of blood glucose) Use SMBG, as currently used in primary care, to monitor and manage glucose over 12 months, in individuals with type 2 diabetes on insulin with or without other glycemic therapies. Glucose management over the 12 months study period will be in primary care, using "usual care" resources. | SMBG Self-monitoring of blood glucose (SMBG)-based glucose monitoring |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in A1C | To evaluate the effectiveness of two glucose monitoring strategies to reduce A1C levels by measuring differential within-patient change by study arm in A1C (%) from baseline to 12 months. | 12 months |
Change in Diabetes Distress | To evaluate the effectiveness of two glucose monitoring strategies to reduce diabetes distress by measuring differential within-patient change by study arm in Diabetes Distress Scale scores from baseline to 12 months. | 12 months |
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
- Age 18 to 75 (inclusive)
- Diagnosis of type 2 diabetes
- A1C 7.5% to 12% (inclusive) in the last 2 months. (If A1C is older than 2 months at the baseline visit, a point-of-care or lab A1C may be done for eligibility)
- Insulin use with or without other classes of glycemia medication use
- No significant comorbidities that could impair the ability of a primary care team to manage diabetes, including but not limited to end stage renal disease, cognitive impairment, active cancer, and pregnancy
- Established care within the HealthPartners Care Group, no plans to move within the next year, and willing to participate for the duration of the study
- Willing and able to follow procedures for collecting blinded CGM data at baseline, 6 and 12 months follow-up
- Willing to complete surveys at baseline, 3, 6, 9 and 12 months.
- Willing to use SMBG or CGM, depending on randomization, in the way that their care team recommends and/or how they feel is most useful in managing their diabetes
- Not currently using personal CGM
- Not planning to become pregnant
- Unwillingness or inability to provide informed consent
- Deemed not suitable for participation in the study based on any other clinical criteria as determined by study investigator(s)
HealthPartners InstitutePatient-Centered Outcomes Research Institute連絡先情報がありません。
1 1カ国の場所
Minnesota
International Diabetes Center, Saint Louis Park, Minnesota, 55416, United States