DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes
NCT ID: NCT05803473
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2023-04-11
2024-07-29
Brief Summary
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Detailed Description
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Continuous glucose monitoring (CGM) might accommodate this need by providing 288 glucose readings per day compared to usual glucose point-of-care (POC) testing from finger-prick blood 3-5 times per day during admission. CGM glucose levels can be transmitted from the patient's room to a monitoring screen at the nursing stations. This setup is called telemetric CGM. Outstanding results on glycemic and clinical outcomes in an out-hospital setting exist, however, In-hospital CGM has been associated only with a clinically insignificant reduction of mean daily glucose levels and a small increased detection rate of hypoglycemia of glucose levels \<3 mmol/L (\<54 mg/dL) compared to POC. Reasons for this might be that an in-hospital diabetes team (i.e., educated diabetes nurses with CGM competencies) is imperative in achieving optimal use of telemetric CGM.
This trial investigates if telemetric CGM and an in-hospital diabetes team improve patients' in-hospital glycemic and clinical outcomes compared to POC glucose testing and an in-hospital diabetes team
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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POC-arm
Subjects are monitored by point-of-care (POC) glucose testing. Diabetes management is done by usual ward nurses and guided by an in-hospital diabetes team. A blinded CGM is mounted in the POC-arm for outcome analysis.
FreeStyle Precision Pro Glucometer for glucose POC testing
For the POC-arm subjects, glucose assessment is done by standard ward glucometer.
CGM-arm
CGM-arm subjects are monitored by CGM viewed by the in-hospital diabetes team in addition to POC glucose testing performed by usual ward nurses. Diabetes management is done by usual ward nurses by POC glucose testing and guided by an in-hospital diabetes team with acces to CGM data.
Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)
For CGM-arm subjects, glucose data are obtained by the CGM Dexcom G6 which via an iPhone SE 3 transmits data to the in-hospital diabetes team stations to be displayed on an iPad 9 10.2".
Interventions
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Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)
For CGM-arm subjects, glucose data are obtained by the CGM Dexcom G6 which via an iPhone SE 3 transmits data to the in-hospital diabetes team stations to be displayed on an iPad 9 10.2".
FreeStyle Precision Pro Glucometer for glucose POC testing
For the POC-arm subjects, glucose assessment is done by standard ward glucometer.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old
* Willingness and ability to comply with the clinical investigation plan
* Ability to communicate in Danish with the trial personnel
* An expected length of hospital stay for at least two days after enrolment
* If subject with childbearing potential (subject \< 50 years old); willing to have a urine pregnancy test performed and/or to use a highly effective method of contraception (i.e., birth control implant, intrauterine device, birth control shot, or sterilisation).
Exclusion Criteria
* Treated with hydroxyurea/hydroxycarbamid
* Nutritional therapy (continuous enteral or parenteral feeding)
* Clinically relevant pancreatic disease
* Systemic glucocorticoid treatment with prednisone equivalent dose \>5 mg/day
* Expected to require admission to the intensive-care unit
* Anasarca (severe and general edema)
* Dialysis
* Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2
* Known hypersensitivity to the band-aid of the CGM Dexcom G6 sensor.
18 Years
ALL
No
Sponsors
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Peter Kristensen
OTHER
Responsible Party
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Peter Kristensen
Medical Doctor, PhD, Clinical Associate Professor
Principal Investigators
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Peter Lommer Kristensen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital - North Zealand, Department of Endocrinology and Nephrology, Denmark
Katrine Bagge Hansen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital - Herlev-Gentofte, Steno Diabetes Center Copenhagen, Denmark
Locations
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Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen)
Herlev, , Denmark
Copenhagen University Hospital - North Zealand
Hillerød, , Denmark
Countries
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References
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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.
Kristensen PL, Jessen A, Houe SMM, Banck-Petersen P, Schiotz C, Hansen KB, Svendsen OL, Almdal T, Bjerre-Christensen U. Quality of diabetes treatment in four orthopaedic departments in the Capital Region of Denmark. Dan Med J. 2021 Nov 30;68(12):A05210449.
Akiboye F, Sihre HK, Al Mulhem M, Rayman G, Nirantharakumar K, Adderley NJ. Impact of diabetes specialist nurses on inpatient care: A systematic review. Diabet Med. 2021 Sep;38(9):e14573. doi: 10.1111/dme.14573. Epub 2021 May 18.
Swanson CM, Potter DJ, Kongable GL, Cook CB. Update on inpatient glycemic control in hospitals in the United States. Endocr Pract. 2011 Nov-Dec;17(6):853-61. doi: 10.4158/EP11042.OR.
Thabit H, Hovorka R. Glucose control in non-critically ill inpatients with diabetes: towards closed-loop. Diabetes Obes Metab. 2014 Jun;16(6):500-9. doi: 10.1111/dom.12228. Epub 2013 Nov 24.
Olsen MT, Dungu AM, Klarskov CK, Jensen AK, Lindegaard B, Kristensen PL. Glycemic variability assessed by continuous glucose monitoring in hospitalized patients with community-acquired pneumonia. BMC Pulm Med. 2022 Mar 9;22(1):83. doi: 10.1186/s12890-022-01874-7.
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.
Klarskov CK, Windum NA, Olsen MT, Dungu AM, Jensen AK, Lindegaard B, Pedersen-Bjergaard U, Kristensen PL. Telemetric Continuous Glucose Monitoring During the COVID-19 Pandemic in Isolated Hospitalized Patients in Denmark: A Randomized Controlled Exploratory Trial. Diabetes Technol Ther. 2022 Feb;24(2):102-112. doi: 10.1089/dia.2021.0291. Epub 2022 Jan 4.
Seisa MO, Saadi S, Nayfeh T, Muthusamy K, Shah SH, Firwana M, Hasan B, Jawaid T, Abd-Rabu R, Korytkowski MT, Muniyappa R, Antinori-Lent K, Donihi AC, Drincic AT, Luger A, Torres Roldan VD, Urtecho M, Wang Z, Murad MH. A Systematic Review Supporting the Endocrine Society Clinical Practice Guideline for the Management of Hyperglycemia in Adults Hospitalized for Noncritical Illness or Undergoing Elective Surgical Procedures. J Clin Endocrinol Metab. 2022 Jul 14;107(8):2139-2147. doi: 10.1210/clinem/dgac277.
Olsen MT, Klarskov CK, Pedersen-Bjergaard U, Hansen KB, Kristensen PL. Summary of clinical investigation plan for The DIATEC trial: in-hospital diabetes management by a diabetes team and continuous glucose monitoring or point of care glucose testing - a randomised controlled trial. BMC Endocr Disord. 2024 May 6;24(1):60. doi: 10.1186/s12902-024-01595-4.
Other Identifiers
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2301240
Identifier Type: -
Identifier Source: org_study_id
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