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治験 NCT02813421（対象：1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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Continue Glucose Monitoring Before Insulin Pump 11 個別化医療
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 NCT02813421 は 介入研究 臨床試験 で、1型糖尿病 を対象とした研究でした。現在は 完了 です。2016年3月1日 に開始し、11 名の参加者 が参加しました。この試験は Children's Hospital Los Angeles によって主導され、2017年5月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2021年5月25日 です。
概要
The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.
詳細説明
This is a prospective, randomized controlled study. Participants will be asked to wear a Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump therapy. Depending on randomization groups, participants will either have CGM data used inform starting insulin pump doses (treatment group), or to standard of care for starting on insulin pump (control group). Participants will wear the ...もっと見る
公式タイトル
Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy
疾患名
1型糖尿病その他の研究識別子
- CHLA-15-00535
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
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的CGM Informed CGM data was available for use when determining starting insulin pump doses. | CGM Informed |
非介入Control CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care. | 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 |
|---|---|---|
Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) | First 6 weeks of insulin pump therapy |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL) | First 5 days of insulin pump therapy | |
Mean Blood Glucose (mg/dL) | Other measures of glycemic variability obtained by iPro2 download | First 6 weeks of insulin pump therapy |
Percentage Time Hyperglycemic | Data obtained by iPro2 download | First 6 weeks of insulin pump therapy |
Total Daily Insulin Dose (Units) | Will be obtained by insulin pump download. | First 6 weeks of insulin pump therapy |
Percentage Basal Insulin (%) | Will be obtained by insulin pump download. | First 6 weeks of insulin pump therapy |
Total Number of Insulin Dose Adjustments | This data will be collected on standardized log sheets. | First 6 weeks of insulin pump therapy |
Total Number of Phone Calls to Clinic Hotline | This data will be collected on standardized log sheets. | First 6 weeks of insulin pump therapy |
Number of Insulin Dose Adjustments Made Per Phone Call | This data will be collected on standardized log sheets. | First 6 weeks of insulin pump therapy |
Episodes of DKA | First 6 weeks of insulin pump therapy | |
Total Number of Episodes of Severe Hypoglycemia | First 6 weeks of insulin pump therapy | |
Hemoglobin A1c (%) | Difference in HbA1c from baseline to 3 months post-pump start | Baseline to 3 months post-pump start |
Number of Participants With Satisfaction of Transition to Pump Therapy | 6 question survey addressing patient/parent impressions of the process of transitioning to insulin pump therapy. | At 6 weeks after start of insulin pump therapy |
適格基準
対象年齢
小児, 成人
試験の最低年齢
2 Years
対象性別
全て
Males and Females aged 2-24 years
Clinical diagnosis of Type 1 diabetes mellitus
Duration of diabetes: At least 6 months
- This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.
Basal/bolus insulin regimen using long-acting and rapid-acting insulin
- This will provide a uniform method of insulin therapy.
Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
Willingness to wear the iPro®2 for 5 days continuously per insertion
Participant agrees to comply with the study protocol requirements
Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian
- Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
- Glucocorticoid use within 2 weeks of study enrollment
- Concurrent use of other medications that may affect glycemic control
- Prior CGM use in the past 6 months
- The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.
- Non-English or non-Spanish speaking
Children's Hospital Los Angeles責任者
Jessica Ferris, MD, 主任研究者, Clinical Fellow, Children's Hospital Los Angeles
連絡先情報がありません。
1 1カ国の場所
California
Children's Hospital Los Angeles, Los Angeles, California, 90027, United States