Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM) (ICU-TeleCGM)
2026年8月13日 更新者：Imperial College Healthcare NHS Trust
The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit.
The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high.
調査の概要
状態
まだ募集していません
詳細な説明
Aim: To assess safety and implementation of networked CGM with ViewsEMR® telemetry within ICU.
The study will be conducted in a two-stage process:
- Phase 1: A single arm (non-randomised) unmasked feasibility study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry. This phase will be conducted at a single site at Imperial College Healthcare NHS Trust (ICHNT).
- Phase 2: A randomised, parallel-group pilot study with adjunctive use of networked CGM using the Dexcom G7 system and ViewsEMR® telemetry compared to standard of care. This phase will be conducted at three hospitals within the same site: ICHNT (St Mary's Hospital, Charing Cross Hospital and Hammersmith Hospital). The study will be conducted at Imperial College Healthcare NHS Trust in people with hyperglycaemia on admission to ICU requiring insulin.
研究の種類
観察的
入学 (推定)
70
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Parizad Avari, MBBS, PhD
- 電話番号：020 33133706
- メール：p.avari@nhs.net
研究連絡先のバックアップ
- 名前：Narvada Jugnee, MSc
- 電話番号：020 33133706
- メール：n.jugnee@nhs.net
研究場所
-
-
-
London、イギリス
- Imperial College Healthcare NHS Trust
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adults admitted to the intensive care unit with hyperglycaemia
説明
Inclusion Criteria:
- Age >18years inclusive
- Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU
- Admission to ICU within 48hours
Exclusion Criteria:
- Known significant allergy to tape/ adhesives
- Imminent death or anticipated length of stay <24hours
- Women who are pregnant
- Imminent extracorporeal membrane oxygenation (ECMO)
- Requirement for therapeutic temperature control (i.e. cooling) post cardiac arrest
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Adjunctive use of continuous glucose monitoring (Dexcom G7) with telemetry (ViewsEMR/CampViews®)
|
Continuous glucose monitoring.
ViewsEMR Telemetry is a digital platform used to monitor participants' real-time CGM data and glucose trends
|
|
Usual care + masked Dexcom G7
Use of continuous glucose monitoring (Dexcom G7) without telemetry (ViewsEMR/CampViews®)
|
Continuous glucose monitoring.
|
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 |
|---|---|---|
|
Phase 1: Eligible participants that consent to participate.
時間枠：Throughout Phase 1 study period, up to 6 months
|
Percentage of eligible participants that consent to participate, including the percentage enrolled through participant informed consent, via personal consultee, and via nominated consultee.
|
Throughout Phase 1 study period, up to 6 months
|
|
Phase 1: Time from admission to ICU to initiation of CGM
時間枠：From admission to ICU to initiation of CGM, up to 48 hours
|
Time in minutes from admission to ICU to initiation of CGM
|
From admission to ICU to initiation of CGM, up to 48 hours
|
|
Phase 1: Time from consent to initiation of CGM
時間枠：From enrollment to the end of intervention at 10 days
|
Time from consent to initiation of CGM
|
From enrollment to the end of intervention at 10 days
|
|
Phase 1: Percentage of CGM data availability for each participant
時間枠：From enrollment to the end of intervention at 10 days
|
Percentage of CGM data availability for each participant
|
From enrollment to the end of intervention at 10 days
|
|
Phase 1: Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
時間枠：From enrollment to the end of intervention at 10 days
|
Percentage of participants successfully set-up on telemetry (ViewsEMR ®)
|
From enrollment to the end of intervention at 10 days
|
|
Phase 1: Number of premature sensor failures per participant (defined as <70% of anticipated use)
時間枠：From enrollment to the end of intervention at 10 days
|
Number of premature sensor failures per participant (defined as <70% of anticipated use)
|
From enrollment to the end of intervention at 10 days
|
|
Phase 1: Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
時間枠：From enrollment to the end of intervention at 10 days
|
Number and type of adverse events related to CGM use (e.g., skin irritation, device malfunction)
|
From enrollment to the end of intervention at 10 days
|
|
Phase 1: Proportion of participants completing the study
時間枠：Throughout Phase 1 study period, up to 6 months
|
Proportion of participants completing the study
|
Throughout Phase 1 study period, up to 6 months
|
|
Phase 1: Proportion of nursing staff completing study survey
時間枠：Throughout Phase 1 study period, up to 6 months
|
Proportion of nursing staff completing study survey
|
Throughout Phase 1 study period, up to 6 months
|
|
Phase 2: Number of episodes of hypoglycaemia per participant
時間枠：Throughout Phase 2, up to 30 days
|
Number of episodes of hypoglycaemia per participant (defined as <3.9mmol/L for 15minutes)
|
Throughout Phase 2, up to 30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1: Safety Outcomes
時間枠：From enrollment to the end of intervention, up to 10 days
|
- Duration of CGM signal loss (units: minutes)
|
From enrollment to the end of intervention, up to 10 days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, Burroughs H, Jinks C. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi: 10.1007/s11135-017-0574-8. Epub 2017 Sep 14.
- Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.
- Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.
- Pickup JC, Freeman SC, Sutton AJ. Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. BMJ. 2011 Jul 7;343:d3805. doi: 10.1136/bmj.d3805.
- Agarwal S, Mathew J, Davis GM, Shephardson A, Levine A, Louard R, Urrutia A, Perez-Guzman C, Umpierrez GE, Peng L, Pasquel FJ. Continuous Glucose Monitoring in the Intensive Care Unit During the COVID-19 Pandemic. Diabetes Care. 2021 Mar;44(3):847-849. doi: 10.2337/dc20-2219. Epub 2020 Dec 23.
- Sadhu AR, Serrano IA, Xu J, Nisar T, Lucier J, Pandya AR, Patham B. Continuous Glucose Monitoring in Critically Ill Patients With COVID-19: Results of an Emergent Pilot Study. J Diabetes Sci Technol. 2020 Nov;14(6):1065-1073. doi: 10.1177/1932296820964264. Epub 2020 Oct 16.
- Curkendall SM, Natoli JL, Alexander CM, Nathanson BH, Haidar T, Dubois RW. Economic and clinical impact of inpatient diabetic hypoglycemia. Endocr Pract. 2009 May-Jun;15(4):302-12. doi: 10.4158/EP08343.OR.
- Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.
- Holzinger U, Warszawska J, Kitzberger R, Wewalka M, Miehsler W, Herkner H, Madl C. Real-time continuous glucose monitoring in critically ill patients: a prospective randomized trial. Diabetes Care. 2010 Mar;33(3):467-72. doi: 10.2337/dc09-1352. Epub 2009 Dec 10.
- Turchin A, Matheny ME, Shubina M, Scanlon JV, Greenwood B, Pendergrass ML. Hypoglycemia and clinical outcomes in patients with diabetes hospitalized in the general ward. Diabetes Care. 2009 Jul;32(7):1153-7. doi: 10.2337/dc08-2127.
- Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, Jones PW. Hyperglycaemia is associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2006 Apr;61(4):284-9. doi: 10.1136/thx.2005.051029. Epub 2006 Jan 31.
- Dhatariya KK, Umpierrez G. Gaps in our knowledge of managing inpatient dysglycaemia and diabetes in non-critically ill adults: A call for further research. Diabet Med. 2023 Mar;40(3):e14980. doi: 10.1111/dme.14980. Epub 2022 Nov 16.
- Avari P, Lumb A, Flanagan D, Rayman G, Misra S, Dhatariya K, Choudhary P. Continuous Glucose Monitoring Within Hospital: A Scoping Review and Summary of Guidelines From the Joint British Diabetes Societies for Inpatient Care. J Diabetes Sci Technol. 2023 May;17(3):611-624. doi: 10.1177/19322968221137338. Epub 2022 Nov 28.
- Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.
- Zelada H, Perez-Guzman MC, Chernavvsky DR, Galindo RJ. Continuous glucose monitoring for inpatient diabetes management: an update on current evidence and practice. Endocr Connect. 2023 Sep 25;12(10):e230180. doi: 10.1530/EC-23-0180. Print 2023 Oct 1.
- Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.
- Faulds ER, Boutsicaris A, Sumner L, Jones L, McNett M, Smetana KS, May CC, Buschur E, Exline MC, Ringel MD, Dungan K. Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4007-e4016. doi: 10.1210/clinem/dgab409.
- Heinemann L, Deiss D, Hermanns N, Graham C, Kaltheuner M, Liebl A, Price D. HypoDE: Research Design and Methods of a Randomized Controlled Study Evaluating the Impact of Real-Time CGM Usage on the Frequency of CGM Glucose Values <55 mg/dl in Patients With Type 1 Diabetes and Problematic Hypoglycemia Treated With Multiple Daily Injections. J Diabetes Sci Technol. 2015 May;9(3):651-62. doi: 10.1177/1932296815575999. Epub 2015 Mar 9.
- Wexler DJ, Meigs JB, Cagliero E, Nathan DM, Grant RW. Prevalence of hyper- and hypoglycemia among inpatients with diabetes: a national survey of 44 U.S. hospitals. Diabetes Care. 2007 Feb;30(2):367-9. doi: 10.2337/dc06-1715. No abstract available.
- Tomlin AM, Tilyard MW, Dovey SM, Dawson AG. Hospital admissions in diabetic and non-diabetic patients: a case-control study. Diabetes Res Clin Pract. 2006 Sep;73(3):260-7. doi: 10.1016/j.diabres.2006.01.008. Epub 2006 Feb 28.
- Sarkisian S, Fenton TR, Shaheen AA, Raman M. Parenteral nutrition-associated hyperglycemia in noncritically ill inpatients is associated with higher mortality. Can J Gastroenterol. 2010 Jul;24(7):453-7. doi: 10.1155/2010/718526.
- Hulkower RD, Pollack RM, Zonszein J. Understanding hypoglycemia in hospitalized patients. Diabetes Manag (Lond). 2014 Mar;4(2):165-176. doi: 10.2217/DMT.13.73.
- Cook CB, Kongable GL, Potter DJ, Abad VJ, Leija DE, Anderson M. Inpatient glucose control: a glycemic survey of 126 U.S. hospitals. J Hosp Med. 2009 Nov;4(9):E7-E14. doi: 10.1002/jhm.533.
- Litchman ML, Allen NA. Real-Time Continuous Glucose Monitoring Facilitates Feelings of Safety in Older Adults With Type 1 Diabetes: A Qualitative Study. J Diabetes Sci Technol. 2017 Sep;11(5):988-995. doi: 10.1177/1932296817702657. Epub 2017 Apr 5.
- Roussel R, Riveline JP, Vicaut E, de Pouvourville G, Detournay B, Emery C, Levrat-Guillen F, Guerci B. Important Drop in Rate of Acute Diabetes Complications in People With Type 1 or Type 2 Diabetes After Initiation of Flash Glucose Monitoring in France: The RELIEF Study. Diabetes Care. 2021 Jun;44(6):1368-1376. doi: 10.2337/dc20-1690. Epub 2021 Apr 20.
- Parkin CG, Graham C, Smolskis J. Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization. J Diabetes Sci Technol. 2017 May;11(3):522-528. doi: 10.1177/1932296817693253. Epub 2017 Feb 1.
- Davis GM, Faulds E, Walker T, Vigliotti D, Rabinovich M, Hester J, Peng L, McLean B, Hannon P, Poindexter N, Saunders P, Perez-Guzman C, Tekwani SS, Martin GS, Umpierrez G, Agarwal S, Dungan K, Pasquel FJ. Remote Continuous Glucose Monitoring With a Computerized Insulin Infusion Protocol for Critically Ill Patients in a COVID-19 Medical ICU: Proof of Concept. Diabetes Care. 2021 Apr;44(4):1055-1058. doi: 10.2337/dc20-2085. Epub 2021 Feb 9.
- Friman O, Soltani N, Lind M, Zetterqvist P, Balintescu A, Perner A, Oldner A, Rooyackers O, Martensson J. Performance of Subcutaneous Continuous Glucose Monitoring in Adult Critically Ill Patients Receiving Vasopressor Therapy. Diabetes Technol Ther. 2024 Oct;26(10):763-772. doi: 10.1089/dia.2024.0035. Epub 2024 May 31.
- Lumb A, Misra S, Rayman G, Avari P, Flanagan D, Choudhary P, Dhatariya K. Variation in the Current Use of Technology to Support Diabetes Management in UK Hospitals: Results of a Survey of Health Care Professionals. J Diabetes Sci Technol. 2023 May;17(3):733-741. doi: 10.1177/19322968231161076. Epub 2023 Mar 22.
- American Diabetes Association Professional Practice Committee. 16. Diabetes Care in the Hospital: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S295-S306. doi: 10.2337/dc24-S016.
- Avari P, Choudhary P, Lumb A, Misra S, Rayman G, Flanagan D, Dhatariya K; Joint British Diabetes Societies for Inpatient Care (JBDS-IP) group. Using technology to support diabetes care in hospital: Guidelines from the Joint British Diabetes Societies for Inpatient Care (JBDS-IP) group and Diabetes Technology Network (DTN) UK. Diabet Med. 2025 Mar;42(3):e15452. doi: 10.1111/dme.15452. Epub 2024 Oct 21.
- Bengtsson M. How to plan and perform a qualitative study using content analysis. NursingPlus Open. 2016;2:8-14. doi:10.1016/J.NPLS.2016.01.001
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年6月1日
研究の完了 (推定)
2028年6月1日
試験登録日
最初に提出
2026年5月29日
QC基準を満たした最初の提出物
2026年8月13日
最初の投稿 (実際)
2026年8月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月17日
QC基準を満たした最後の更新が送信されました
2026年8月13日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 167867
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?
いいえ
IPD プランの説明
Ethics approval does not allow sharing of individual participant data
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。