DIAbetes TEam and Cgm in Managing Hospitalised Patients With Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— DIATEC  

Official title:

In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803473
• Other study ID #: 2301240
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Nordsjaellands Hospital
• Contact: Mikkel Thor Olsen, MD
• Phone: 31497295
• Email: mikkel.thor.schuster.olsen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial investigates the effects of continuous glucose monitoring (CGM) and an in-hospital diabetes team on in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard glucose point-of-care (POC) testing and an in-hospital diabetes team.

Description:

In Denmark and worldwide, 15-20 % of hospitalised patients have diabetes mellitus. For most patients, diabetes is not the primary cause of admission. The patients are therefore under the care of non-diabetes specialists. Consequently, diabetes management can be inadequate resulting in hypoglycemia, hyperglycemia, and increased glycemic variability, which might increase patient mortality, morbidity, and length of hospital stay. Despite these challenges, a recent review concludes that in-hospital diabetes management is under-researched. Therefore, new in-hospital diabetes management strategies are greatly needed. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A documented history of T2DM prior to inclusion
• 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:

• Patients on out-hospital basal insulin with duration of action > 24 hours (Toujeo or Tresiba)
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen)	Herlev
Denmark	Copenhagen University Hospital - North Zealand	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Peter Kristensen

Country where clinical trial is conducted

Denmark, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay	The length of hospital stay from inclusion to discharge.	During hospitalization (up to 30 days)
Other	Number of In-hospital complications	Any in-hospital related complications occurring at least one day after randomisation (e.g. acute kidney injury, death during hospitalisation, transfer to intensive care unit etc.).	During hospitalization (up to 30 days)
Other	Number of times insulin is administered	The number of times basal, prandial, and correctional insulin is used in total and correctly used according to clinical investigation plan specifications.	During hospitalization (up to 30 days)
Other	Insulin doses	Basal, prandial, and correctional insulin doses in total.	During hospitalization (up to 30 days)
Other	Readmissions and mortality	Assesment of 30-day numbers of readmissions and mortality.	30-day after discharge from hospital
Other	Questionnaires	Subject and in-hospital diabetes team user satisfaction levels with in-hospital telemetric CGM are assessed by validated questionnaires.	During hospitalization (up to 30 days)
Primary	Time in range	Time in range (TIR) is defined as the percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.	During hospitalization (up to 30 days)
Secondary	Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL)	Percentage of time in range assessed each day of inclusion; amount of time (hours and minutes).	During hospitalization (up to 30 days)
Secondary	Time above range (TAR) >10.0 mmol/L (>180 mg/dL)	Percentage of time above range; amount of time (hours and minutes).	During hospitalization (up to 30 days)
Secondary	Time above range (TAR) >13.9 mmol/L (>250 mg/dL)	Percentage of time above range; amount of time (hours and minutes).	During hospitalization (up to 30 days)
Secondary	Time below range (TBR) <3.9 mmol/L (<70 mg/dL)	Percentage of time below range; amount of time (hours and minutes)	During hospitalization (up to 30 days)
Secondary	Time below range (TBR) <3.0 (<54 mg/dL)	Percentage of time below range; amount of time (hours and minutes)	During hospitalization (up to 30 days)
Secondary	Standard deviation (SD) of all CGM glucose levels	mmol/L (mg/dL)	During hospitalization (up to 30 days)
Secondary	Coefficient of variation (CV)	SD divided by mean glucose level	During hospitalization (up to 30 days)
Secondary	Mean glucose levels	mmol/L (mg/dL)	During hospitalization (up to 30 days)
Secondary	Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)	mmol/L (mg/dL), duration =15 consecutive min.	During hospitalization (up to 30 days)
Secondary	Hypoglycemia (level 1) 3.0-3.8 mmol/L (54-69 mg/dL)	mmol/L (mg/dL), duration =15 consecutive min.	During hospitalization (up to 30 days)
Secondary	Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)	mmol/L (mg/dL), duration =15 consecutive min.	During hospitalization (up to 30 days)
Secondary	Recurrent hypoglycemic events	Number; Reoccurring hypoglycemic events after the first episode of hypoglycemia.	During hospitalization (up to 30 days)

External Links

•   In-hospital diabetes status on glycemic control.
•   In-hospital diabetes status on glycemic control.