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Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin. 108 無作為化 非盲検

募集準備中
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治験番号 NCT07308925 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 募集準備中 で、2026年1月31日 に開始予定です。108 名の参加者 の募集が計画されています。この試験は Hospital Universitario San Ignacio によって主導され、2028年12月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月30日 です。
概要
The objective is to compare the efficacy of TR-CGM versus isCGM in patients diagnosed with T2D who are treated with insulin and use CGM, as defined by time in range between 70 and 180 mg/dL.

An open-label clinical trial will be conducted. Patients with T2D who use intermittent glucose monitoring and insulin with poor metabolic control will be included. They will be randomized to continue with isCGM or RT-CGM.

The p...

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詳細説明
All patients diagnosed with type 2 diabetes (T2D) who meet the inclusion criteria will be identified (see inclusion and exclusion criteria). They will then be invited to participate in the study and asked to sign an informed consent form. Demographic data, baseline clinical characteristics, and clinical tests related to metabolic control will be collected.

Visit 0 (V0): Informed consent signature and basal CGM syste...

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公式タイトル

Effectiveness of Using Real-time Continuous Glucose Monitoring Compared With Intermittent Continuous Glucose Monitoring in People With Type 2 Diabetes Treated With Insulin.

疾患名
2型糖尿病
その他の研究識別子
  • FM-CIE-1013-24
NCT番号
NCT07308925
開始日
2026-01-31
最終更新日
2025-12-30
終了予定日
2028-12-30
目標参加者数
108
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
Type 2 Diabetes
Continuous Glucose Monitoring
Time in Range
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
非介入isCGM
Usual Care + isCGM Group: Patients in this group will have the FreeStyle Libre 2 continuous interstitial glucose monitoring sensor (Abbott Diabetes Care Inc., Alameda, CA, USA) inserted. High glucose alarms (\>250 mg/dL) and low glucose alerts (\<70 mg/dL) will be programmed. They will also be instructed to perform at least eight scans daily to avoid data loss. All participants were instructed to replace their sensor...もっと見る
該当なし
実験的RT-CGM
• Usual care + TR-CGM group: Patients in this group will undergo insertion of a continuous interstitial glucose monitoring (CGM) sensor using the FreeStyle Libre 2 Plus device and LibreLink app® (Abbott Diabetes Care, Inc., Alameda, CA, USA). The sensor will be programmed with high glucose alarms (\>250 mg/dL) and low glucose alerts (\<70 mg/dL). All participants will be instructed to replace their sensor according t...もっと見る
real time Continuous Glucose Monitoring
• Usual care + TR-CGM group: Patients in this group will undergo insertion of a continuous interstitial glucose monitoring (CGM) sensor using the FreeStyle Libre 2 Plus device and LibreLink app® (Abbott Diabetes Care, Inc., Alameda, CA, USA). The sensor will be programmed with high glucose alarms (\>250 mg/dL) and low glucose alerts (\<70 mg/dL). All participants will be instructed to replace their sensor according t...もっと見る
主要評価項目
評価指標指標の説明時間枠
Time in Range
To compare the efficacy defined as time in range between 70 - 180 mg/dl of the TR-CGM compared to isCGM in patients diagnosed with T2DM treated with insulin who use CGM as part of usual clinical practice in follow-up at the endocrinology unit of the San Ignacio University Hospital.
12 weeks
副次評価項目
評価指標指標の説明時間枠
Proportion of patients with a ≥5% increase in TIR
Compare the proportion of patients with a ≥5% increase in TIR 70-180 mg/dl compared to the initial value.
12 weeks
TAR
To compare percentage of time in hyperglycemia range \>180 and \>250 mg/dl
12 weeks
TBR <70 mg/dl
To compare the proportion of patients with a %TBR \<70 mg/dL to less than 4%
12 weeks
TBR <54 mg/dl
To compare the proportion of patients with a %TBR \<54 mg/dL to less than 1%
12 weeks
Severe hypoglycemia
To compare the incidence of severe hypoglycemia, hospitalizations, and emergency department visits.
12 weeks
Satisfaction with the device
To compare satisfaction with the device using the "Questionnaire on experience with glucose monitoring (C-EMC)" at the end of the follow-up.
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
35 Years
対象性別
全て
  • Minimum age of 35 years.
  • HbA1c >7.0%
  • Treatment with one or more insulin injections.
  • Stable medication regimen for the 3 months prior to study entry.
  • Insulin treatment for ≥3 months with a stable dose prior to entry, with fasting blood glucose between 70 and 130 mg/dL.
  • Availability of an NFC-enabled smartphone.

  • Pregnancy or planning to become pregnant during the study period.
  • History of bariatric surgery within the year prior to study entry or plans to undergo bariatric surgery during the study.
  • Having a condition that would likely require an MRI during the study period.
  • Use of medications containing high doses of ascorbic acid (>2000 mg/day), as it may falsely increase sensor readings.
  • Concomitant illness or condition that may compromise patient safety, including, but not limited to, serious mental illness, a diagnosed or suspected eating disorder, or any long-term medical/unmanageable disorder.
  • GFR less than 30 ml/min.
  • Psychiatric condition that interferes with study-related tasks.
  • Known (or suspected) significant allergy to medical-grade adhesives.
Hospital Universitario San Ignacio logoHospital Universitario San Ignacio
Pontificia Universidad Javeriana logoPontificia Universidad Javeriana
試験中央連絡先
連絡先: Diana C Henao, Endocrinologyst, +57 601 5946161, [email protected]
連絡先: Adriana L Gonzáles, Nutricionist, +57 601 5946161, [email protected]
1 1カ国の場所
Hospital Universitario San Ignacio, Bogotá, 111121, Colombia
Diana C Henao-Carrillo, Endocrinologyst, 連絡先, +57 601 5946161, [email protected]
Adriana G Gómez-Velasquez, Nutricionist, 連絡先, +57 601 5946161, [email protected]
Diana C Henao-Carrillo, Endocrinologyst, 主任研究者