Clinical Trial Radar

Name: In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial
Creator: Peter Kristensen
Published: 2023-04-07
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT05803473 (DIATEC) for Diabetes Mellitus, Type 2 is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes (DIATEC) 166

Completed

Clinical Trial NCT05803473 (DIATEC) was an interventional study for Diabetes Mellitus, Type 2 that is now completed. The study started on 11 April 2023, with plans to enroll 166 participants. Led by Peter Kristensen, the expected completion date was 29 July 2024. The latest data from ClinicalTrials.gov was last updated on 26 February 2025.

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.

Detailed 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 hosp...Show More

Official Title

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

Conditions

Diabetes Mellitus, Type 2

Publications

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.

Other Study IDs

DIATEC
2301240

NCT ID Number

NCT05803473

Start Date (Actual)

2023-04-11

Last Update Posted

2025-02-26

Completion Date (Estimated)

2024-07-29

Enrollment (Estimated)

166

Study Type

Interventional

PHASE

N/A

Status

Completed

Keywords

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

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Active ComparatorPOC-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.
ExperimentalCGM-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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
Standard deviation (SD) of all CGM glucose levels	mmol/L (mg/dL)	During hospitalization (up to 30 days)
Coefficient of variation (CV)	SD divided by mean glucose level	During hospitalization (up to 30 days)
Mean glucose levels	mmol/L (mg/dL)	During hospitalization (up to 30 days)
Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)	mmol/L (mg/dL), duration ≥15 consecutive min.	During hospitalization (up to 30 days)
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)
Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)	mmol/L (mg/dL), duration ≥15 consecutive min.	During hospitalization (up to 30 days)
Recurrent hypoglycemic events	Number; Reoccurring hypoglycemic events after the first episode of hypoglycemia.	During hospitalization (up to 30 days)

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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).

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.

Peter Kristensen

Study Responsible Party

Peter Kristensen, Sponsor-Investigator, Medical Doctor, PhD, Clinical Associate Professor, Nordsjaellands Hospital

No contact data.

2 Study Locations in 1 Countries

Denmark

Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen), Herlev, 2730, Denmark

Copenhagen University Hospital - North Zealand, Hillerød, 3400, Denmark

DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes (DIATEC) 166

Inclusion Criteria

Exclusion Criteria