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治験 NCT07135531（対象：糖尿病、糖尿病、2型糖尿病）は募集準備中です。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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チュレーン大学Continuous Glucose Monitoring (CGM) in an Underserved Population 50 無作為化 医療過疎地
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 NCT07135531 は 介入研究 臨床試験 で、糖尿病、糖尿病、2型糖尿病 に関するものです。現在は 募集準備中 で、2026年3月1日 に開始予定です。50 名の参加者 の募集が計画されています。この試験は チュレーン大学 によって主導され、2027年7月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月2日 です。
概要
The investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. The investigators believe that this study will lead to considerable alleviation of health disparities and provide better care for an underserved population. This will be a pilot study to evaluate the feasibility of such a trial in this...もっと見る
詳細説明
This study is a randomized open label trial with study participants being randomized to either a continuous glucose monitoring group (intervention) or a self-monitoring group (control) after a period of two-week run-in and followed for 6 months. All participants regardless of assignment will be provided diabetes education. Participants randomized to the self-monitoring group will be given an opportunity to wear the C...もっと見る
公式タイトル
Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications
疾患名
糖尿病糖尿病2型糖尿病その他の研究識別子
- 2024-1872
NCT番号
開始日
2026-03
最終更新日
2026-03-02
終了予定日
2027-07
目標参加者数
50
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Medicaid
Underinsured
Continuous glucose monitoring
Uninsured
Underinsured
Continuous glucose monitoring
Uninsured
主目的
予防
割付方法
無作為化
介入モデル
クロスオーバー法
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 |
|---|---|
プラセボ対照薬Self-Monitoring of Blood Glucose (SMBG) The study participants will be randomized to the self-monitoring group (control) after a period of two-week run-in and followed for 6 months. They will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up. | Continuous Glucose Monitoring (CGM) Continuous glucose monitors will be placed subcutaneously every 14 days. |
実薬対照薬Continuous Glucose Monitoring (CGM) The study participants will be randomized to the continuous glucose monitoring group (intervention). | Continuous Glucose Monitoring (CGM) Continuous glucose monitors will be placed subcutaneously every 14 days. |
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 Glycated hemoglobin (HbA1c) between baseline and 6-month visits for both groups | The investigators will take blood samples at baseline and at the 6 months visit to measure the HbA1c levels. Change in the level of HbA1c at 6 months will be compared between the 2 groups to assess the outcome. | Baseline, 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Time in Range (TIR) | TIR is a percentage of time that a person with diabetes spends within their target blood glucose range. The investigators will review the data from the CGM devices and assess if there are any changes in the TIR between the 2 groups at baseline and at 6 months. The higher the percentage is for TIR, the better the blood glucose control is for patients. | Baseline, 6 months |
Change in documented hypoglycemia <70 mg/ dl and severe hypoglycemia - <54 mg/dl | The investigators will measure the change in documented hypoglycemia and severe hypoglycemia in patients in both groups at baseline and at 6 months. The lower the numbers of the hypoglycemia incidences, the better the outcome is.
Documented hypoglycemia and severe hypoglycemia will be measured as a percentage of time that a person with diabetes below their target blood glucose range. | Baseline, 6 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 18-75 years
- Type 2 diabetes mellitus
- HbA1C ≥ 7.5%
- At least on 1 insulin injection therapy daily
- Patients established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas
- Patients with Medicaid or free care or uninsured
- Patients must be able to speak and understand English and be capable of providing informed consent to participate in the study
- Type 1 diabetes mellitus
- Currently on CGM or using insulin pump
- Advanced renal disease or Estimated Glomerular Filtration Rate (eGFR) <40
- Serious co-morbidities which in the investigator's opinion, will make it challenging for patients to participate
- The patient has been diagnosed with end-stage renal disease, is on dialysis, or has had a kidney transplant, Hemoglobinopathies, iron therapy or other condition that interferes with HbA1c measurement
- Pregnant
チュレーン大学60 件のアクティブな治験を探索試験中央連絡先
連絡先: Neha Upadhyay, BDS,MPH, 5049889803, [email protected]
連絡先: Ayitevi Agbodji, MD,MPH&TM, 504-988-9839, [email protected]
1 1カ国の場所
Louisiana
University Medical Center, New Orleans, Louisiana, 70112, United States
Neha Upadhyay, BDS,MPH, 連絡先, 504-988-9803, [email protected]
Ayitevi Agbodji, MD,MPH&TM, 連絡先, 504-988-9839, [email protected]
Shaveta Gupta, MD, 主任研究者