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治験 NCT05516797 (IGNITE)（対象：2型糖尿病）は完了です。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
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IGNITE (Impact of Glucose moNitoring and nutrItion on Time in rangE) 178
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 NCT05516797 (IGNITE) は 介入研究 臨床試験 で、2型糖尿病 を対象とした研究でした。現在は 完了 です。2022年9月22日 に開始し、178 名の参加者 が参加しました。この試験は HealthPartners Institute によって主導され、2024年3月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2025年3月26日 です。
概要
The purpose of this study is to learn whether there is a difference in the amount of time glucose (blood sugar) stays within a target range (glucose 70 - 180 mg/dl) when using either continuous glucose monitoring (CGM) or fingerstick blood glucose monitoring (BGM) in people with Type 2 diabetes who participate in the Virta Treatment program.
詳細説明
The purpose of this three-month, randomized, controlled trial is to compare the difference in change in 14-day CGM-derived TIR (% time with glucose 70-180 mg/dL) from Baseline to 3-months Post-Dietary Change in participants with T2D who are assigned to use either BGM or CGM. The difference in mean blood ketone levels and additional glycemic endpoints will also be compared, and several exploratory endpoints, including...もっと見る
公式タイトル
Continuous Glucose Monitoring Versus Blood Glucose Monitoring to Optimize Glycemic Outcomes in People With Type 2 Diabetes Following the Virta Treatment Program" (IGNITE: Impact of Glucose moNitoring and nutrItion on Time in rangE Study)
疾患名
2型糖尿病その他の研究識別子
- IGNITE
- A22-076
NCT番号
開始日
2022-09-22
最終更新日
2025-03-26
終了予定日
2024-03-01
目標参加者数
178
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
キーワード
Continuous Glucose Monitoring (CGM)
Blood Glucose Monitoring (BGM)
Nutrition Therapy
Blood Glucose Monitoring (BGM)
Nutrition Therapy
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Continuous Glucose Monitoring (CGM) Participants in this arm will use the FreeStyle Libre 2 CGM sensor. | Continuous Glucose Monitoring (CGM) Use of CGM (FreeStyle Libre 2) compared to BGM for glucose monitoring |
非介入Blood Glucose Monitoring (BGM) Participants in this arm will use the Precision Xtra fingerstick blood glucose meter throughout the study. | 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 |
|---|---|---|
Difference in Change in 14-day CGM-derived TIR From (3 Months Minus Baseline) | Change in 14-day CGM-derived TIR (% time with glucose 70-180 mg/dL) from Baseline to 3-month Post-Dietary Change period between participants with T2D who are randomized to use either BGM or CGM (3 months minus baseline) | Three (3) months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
90-day Mean Blood Ketone Levels | Mean of blood ketone levels from day 0 to day 90 (three months). | Three (3) months / 90 days |
Participants Reaching CGM-derived Consensus Targets | Percent of participants reaching CGM-derived consensus targets (targets defined as meeting both \>70% TIR70-180 mg/dL and \<4% TBR \<70mg/dL) at the end of the 3-month Post-Dietary in both the BGM and CGM arms | Three (3) months |
Difference in Change in HbA1c | Change in HbA1c from Baseline to the end of the 3-month Post-Dietary Change period between BGM and CGM arms | Three (3) months |
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 years
- U.S. residence with plans to remain in the U.S. for study duration (for shipping purposes)
- Diagnosis of T2D
- HbA1c between 7.5-11.5% documented within 60 days prior to consent
- Stable diabetes medication regimen and lifestyle patterns (eating and activity) within approximately 90 days prior to consent
- Using at least one glucose-lowering medication (oral or injectable) for diabetes management at the time of consent; if using insulin, this may include up to a total of three or fewer insulin injections per day (e.g., once or twice daily basal insulin, once or twice daily basal insulin plus one prandial insulin dose, once or twice daily pre-mix insulin, or another combination etc.)
- English language comprehension
- Confirmed download of FreeStyle Libre 2 app on personal smartphone with access to WiFi
- Willing and able to record study data using smartphone, tablet, and/or computer
- Willing to wear and use study-provided CGM devices for up to 7 months
- Willing to perform fingersticks to test blood glucose
- Willing to perform fingersticks to test blood ketones twice daily
- Eligible to initiate and intention to participate in the dietary changes required as part of the Virta Treatment for at least 7 months
- Type 1 diabetes
- Currently using an insulin pump or multiple daily injection insulin therapy with >3 insulin injections per day or using bolus injections to cover every meal
- Currently following a self-reported, very low-carbohydrate eating pattern
- Currently using a personal CGM or plans to use a personal CGM during the study period
- Advanced-stage renal, cardiac, hepatic, or other chronic disease
- History of ketoacidosis
- Pregnant, lactating, or planned pregnancy
- Allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
- Participation in another interventional trial at the time of enrollment or during the study period
- Participant is unsuitable for participation due to any cause as determined by Investigators
HealthPartners Institute- Virta Health
連絡先情報がありません。
1 1カ国の場所
Minnesota
Health Partners Institute dba International Diabetes Center, Minneapolis, Minnesota, 55416, United States