DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes

NCT05803473 | Completed FDA Device

• 1 other identifier: 2301240
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Inpatient; Randomised controlled trial; Hyperglycemia; Hypoglycemia; Glycemic variabiity; Continuous glucose monitoring; CGM; In-hospital; Telemetric continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL)

  During hospitalization (up to 30 days)

• Time above range (TAR) >10.0 mmol/L (>180 mg/dL)

  During hospitalization (up to 30 days)

• Time above range (TAR) >13.9 mmol/L (>250 mg/dL)

  During hospitalization (up to 30 days)

• Time below range (TBR) <3.9 mmol/L (<70 mg/dL)

  During hospitalization (up to 30 days)

• Time below range (TBR) <3.0 (<54 mg/dL)

  During hospitalization (up to 30 days)

Other Outcomes (6)

• Length of hospital stay

  During hospitalization (up to 30 days)

• Number of In-hospital complications

  During hospitalization (up to 30 days)

• Number of times insulin is administered

  During hospitalization (up to 30 days)

Study Arms (2)

POC-arm

ACTIVE COMPARATOR

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.

Device: FreeStyle Precision Pro Glucometer for glucose POC testing

CGM-arm

EXPERIMENTAL

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.

Device: Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)

Interventions

Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA) DEVICE

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".

CGM-arm

FreeStyle Precision Pro Glucometer for glucose POC testing DEVICE

For the POC-arm subjects, glucose assessment is done by standard ward glucometer.

POC-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peter Kristensen: lead

Study Sites (2)

Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen)

Herlev, 2730, Denmark

Location

Copenhagen University Hospital - North Zealand

Hillerød, 3400, Denmark

Location

Related Publications (11)

• 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.

  PMID: 11889147 BACKGROUND

• 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.

  PMID: 34851255 BACKGROUND

• 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.

  PMID: 33783872 BACKGROUND

• 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.

  PMID: 21550947 BACKGROUND

• 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.

  PMID: 24267153 BACKGROUND

• 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.

  PMID: 35264139 BACKGROUND

• 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.

  PMID: 16449265 BACKGROUND

• 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.

  PMID: 36256494 BACKGROUND

• 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.

  PMID: 34524009 BACKGROUND

• 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.

  PMID: 35690929 BACKGROUND

• 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.

  PMID: 38711112 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Peter Lommer Kristensen, MD, PhD

  Copenhagen University Hospital - North Zealand, Department of Endocrinology and Nephrology, Denmark

  PRINCIPAL INVESTIGATOR

• Katrine Bagge Hansen, MD, PhD

  Copenhagen University Hospital - Herlev-Gentofte, Steno Diabetes Center Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, PhD, Clinical Associate Professor

Model Details: This is an investigator-initiated, two-site, prospective randomised open-label blinded endpoint (PROBE) trial.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 7, 2023
• Study Start: April 11, 2023
• Primary Completion: March 29, 2024
• Study Completion: July 29, 2024
• Last Updated: February 26, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available at the end of the trial. Anticipation: Year 2025
• Access Criteria: Supporting information is available by request to corresponding author of the planned articles when the trial is completed.

Locations

DK (2)