Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Evaluation of Inter-Arm Differences in Continuous Glucose Monitor Glucose Readings in Patients With Type 1 and Type 2 Diabetes
This is a clinical trial looking at differences in continuous glucose monitor (CGM) glucose readings between the left and right arms in adults with type 1 or type 2 diabetes. The study will enroll 60 participants who will wear a CGM sensor on both arms for 14 days.
調査の概要
状態
詳細な説明
This study is a prospective, non-randomized clinical trial designed to evaluate differences in continuous glucose monitor (CGM) glucose readings between the left and right arms in adults with type 1 or type 2 diabetes.
The study will enroll 60 participants. Each participant will wear two FreeStyle Libre 3 Plus CGM sensors simultaneously for 14 days, with one sensor placed on each arm.
The primary objective is to compare the frequency of hypoglycemic events, defined as glucose readings below 70 mg/dL, between the left and right arms. Secondary analyses will evaluate differences in Level 1 and Level 2 hypoglycemia and time below range. Additional analyses will compare time in range, time above range, time below range, and average glucose between the two arms.
CGM data from the two sensors will be collected and compared to evaluate differences in glucose readings between the left and right arms.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Innovative Clinical and Outcomes Research (iCOR)
- 電話番号：925-255-5374
- メール：icor@pacific.edu
研究場所
-
-
California
-
Stockton、California、アメリカ、95211
- University of the Pacific
-
コンタクト：
- Innovative Clinical and Outcomes Research (iCOR)
- 電話番号：9252555374
- メール：icor@pacific.edu
-
主任研究者：
- Sachin A Shah, PharmD
-
副調査官：
- Allen Shek, PharmD
-
副調査官：
- Aydin Shek
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults 18 years of age and over
- Diagnosed with type 1 or 2 diabetes mellitus
- Female participants with childbearing potential must have a negative urine pregnancy stick test, which has been confirmed by investigators
- Willingness to wear a CGM on each arm for 2 weeks
- A1c <7% within the past 6 months
- Willing to attend 3 virtual call meetings over the course of the trial
- Have active health insurance throughout the duration of the study
- Willing to refrain from consuming or using commercial products containing ascorbic acid (vitamin C) or salicylic acid, and certain skincare products for the duration of the study due to their known potential to interfere with CGM readings (exposure via food is allowed)
- Participants must have a mobile phone that is connected to the internet and compatible with both "FreeStyle Libre 3" and "Libre by Abbott" apps
Exclusion Criteria:
- Under the age of 18
- Any active dermatologic condition on the upper arms
- Implanted medical devices (e.g., pacemaker, insulin pump)
- Use of any medical or other devices (e.g., TMS) incompatible with the FreeStyle Libre 3 Plus CGM
- Critically ill or dialysis patients
- Planned high-frequency electrical heat treatment (diathermy) during the study period
- Currently taking hydroxyurea
- History of or planned gastric bypass within the study period
- Current systemic infections
- Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
- Refusal to sign the informed consent document or HIPAA authorization form
- Pregnant, planned pregnancy during study period, or currently breastfeeding
- History of allergic reactions or hypersensitivity to adhesives
- Blood transfusion within the previous 3 months
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Left and Right Arm CGM Wear
Participants will wear two FreeStyle Libre 3 Plus continuous glucose monitors (CGMs) simultaneously for 14 days, with one sensor applied to the back of the upper arm on each arm. Participants will continue their normal daily routine during the study period. CGM data from the left and right arms will be compared. |
Two FreeStyle Libre 3 Plus continuous glucose monitors (CGMs) will be worn simultaneously for 14 days. One sensor will be applied subcutaneously to the back of the upper arm on each arm. The sensors measure glucose in the interstitial fluid, and data from the left and right arms will be collected and compared. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Frequency of Hypoglycemic Events Between Left and Right Arms
時間枠：14 days
|
Difference in the frequency of hypoglycemic events (<70 mg/dL) between the left arm and right arm. |
14 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Frequency of Level 1 Hypoglycemic Events Between Left and Right Arms
時間枠：14 days
|
Difference in the frequency of Level 1 hypoglycemic events (54 to <70 mg/dL) between the left arm and right arm. |
14 days
|
|
Difference in Frequency of Level 2 Hypoglycemic Events Between Left and Right Arms
時間枠：14 days
|
Difference in the frequency of Level 2 hypoglycemic events (<54 mg/dL) between the left arm and right arm. |
14 days
|
|
Difference in Percentage of Time Below Range (<70 mg/dL) Between Left and Right Arms
時間枠：14 days
|
Difference in percentage of time below range (TBR) <70 mg/dL between the left and right arms. |
14 days
|
|
Difference in Percentage of Time Below Range (54 to <70 mg/dL) Between Left and Right Arms
時間枠：14 days
|
Difference in percentage of time below range (TBR) from 54 to <70 mg/dL (Level 1 hypoglycemia) between the left and right arms. |
14 days
|
|
Difference in Percentage of Time Below Range (<54 mg/dL) Between Left and Right Arms
時間枠：14 days
|
Difference in percentage of time below range (TBR) <54 mg/dL (Level 2 hypoglycemia) between the left and right arms. |
14 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB2026-284
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data will not be shared with others.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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