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治験 NCT05944432（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。 | ||
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アボットCGM Use in Adults With Type 2 Diabetes on Basal Insulin 470 非盲検
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 NCT05944432 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、2023年7月14日 から開始しています。470 名の参加者 の募集が計画されています。この試験は アボット によって主導され、2027年11月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月12日 です。
概要
A prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period. The purpose of this study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 will improve HbA1c compared to SMBG over 16 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy.
詳細説明
The study will assess change in HbA1c as the primary endpoint. Other endpoints related to glycaemic control are included in the analyses. The study is split into two phases each of four months duration: participant-driven (phase 1) and HCP/therapy-driven (phase 2). Participants will be randomised to either FreeStyle Libre 3 or to continuation with their current SMBG device.
公式タイトル
Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1
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
- ADC-UK-PMS-22057
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 |
|---|---|
実薬対照薬FreeStyle Libre system FreeStyle Libre 3 continuous glucose monitoring system | FreeStyle Libre 3 Continuous Glucose Monitoring System. Subjects will be randomised to use the FreeStyle Libre 3 system |
その他Standard of care (control) Self monitoring of blood glucose | Self monitoring of blood glucose Subjects will be randomised to continue with their current glucose monitoring system |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
HbA1c | Difference between treatment groups in mean change from baseline in HbA1c. | 16 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
HbA1c | Difference between treatment groups in mean change from baseline in HbA1c | 32 weeks |
Time in range (TIR) | Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL). | 32 weeks |
Time above range (TAR) | Time spent above glucose target range (TAR) \>10.0 mmol/L, 13.9 mmol/L and 16.7 mmol/L (\>180 mg/dL, \>250 mg/dL and \>300 mg/dL). | 32 weeks |
Time below range(TBR) | Time spent below glucose target range (TBR) \<3.9 mmol/L and \<3.0 mmol/L (\<70 mg/dL and \<54 mg/dL). | 32 weeks |
Frequency of hypoglycaemia events | CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9 mmol/L (\<70 mg/dL). | 32 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
- Aged 18 years or over.
- Type 2 diabetes diagnosis for ≥1 year prior to enrolment.
- Type 2 diabetes treated with a basal insulin injection regimen and SGLT2 inhibitor and/or GLP-1.
- Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive).
- Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.
- Currently participating in another study that could affect glucose measurements or glucose management.
- A female participant who is pregnant.
- A breastfeeding female participant.
- Bariatric surgical procedure within the past 12 months or is planning/scheduled for bariatric surgery within the study duration.
アボット連絡先情報がありません。
25 1カ国の場所
Tameside General Hospital, Ashton-under-Lyne, United Kingdom
Royal United Hospital, Bath, United Kingdom
Queen Elizabeth Hospital, Birmingham, United Kingdom
Cambridge University Hospital (Addenbrookes), Cambridge, United Kingdom
Darlington Memorial Hospital, Darlington, United Kingdom
Royal Derby Hospital, Derby, DE22 3NE, United Kingdom
Ninewells Hospital, Dundee, United Kingdom
Princess Alexandra Hospital, Harlow, United Kingdom
Northwick Park Hospital, Harrow, United Kingdom
Hull Royal Infirmary, Hull, United Kingdom
Ipswich Hospital, Ipswich, United Kingdom
St James University Hospital, Leeds, United Kingdom
Leicester General Hospital, Leicester, United Kingdom
King's College Hospital, London, United Kingdom
St Mary's Hospital, London, United Kingdom
Manchester Royal Infirmary, Manchester, M13 9WU, United Kingdom
Norfolk and Norwich University Hospital, Norwich, United Kingdom
Churchill Hospital, Oxford, United Kingdom
Derriford Hospital, Plymouth, United Kingdom
The Adam Practice, Poole, United Kingdom
Queen Alexandra Hospital, Portsmouth, United Kingdom
Northern General Hospital, Sheffield, United Kingdom
Moorgreen Hospital, Southampton, United Kingdom
Singleton Hospital, Swansea, United Kingdom
Wishaw Hospital, Wishaw, United Kingdom