Diabetes Mellitus, Type 2DIATECNCT05803473
DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes
A study testing Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA) and FreeStyle Precision Pro Glucometer for glucose POC testing in people with Diabetes Mellitus, Type 2, run by Peter Kristensen at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA) and FreeStyle Precision Pro Glucometer for glucose POC testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Apr 2023to 29 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen)
Herlev, 2730
Copenhagen University Hospital - North Zealand
Hillerød, 3400
About this study
Official title: In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial
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.
Read the 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 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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA), FreeStyle Precision Pro Glucometer for glucose POC testing
- Keywords
- Inpatient, Randomised controlled trial, Hyperglycemia, Hypoglycemia, Glycemic variabiity, Continuous glucose monitoring, CGM, In-hospital, Telemetric continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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".
FreeStyle Precision Pro Glucometer for glucose POC testingDevice
For the POC-arm subjects, glucose assessment is done by standard ward glucometer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hospitalization (up to 30 days)
Secondary outcomes (12)
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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: During hospitalization (up to 30 days)
Standard deviation (SD) of all CGM glucose levels
mmol/L (mg/dL)
Measured: During hospitalization (up to 30 days)
Coefficient of variation (CV)
SD divided by mean glucose level
Measured: During hospitalization (up to 30 days)
Mean glucose levels
mmol/L (mg/dL)
Measured: During hospitalization (up to 30 days)
Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)
mmol/L (mg/dL), duration ≥15 consecutive min.
Measured: 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.
Measured: During hospitalization (up to 30 days)
Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)
mmol/L (mg/dL), duration ≥15 consecutive min.
Measured: During hospitalization (up to 30 days)
Recurrent hypoglycemic events
Number; Reoccurring hypoglycemic events after the first episode of hypoglycemia.
Measured: During hospitalization (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start11 Apr 2023
- Primary completion29 Mar 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an investigator-initiated, two-site, prospective randomised open-label blinded endpoint (PROBE) trial.
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Kristensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Kristensen, Nordsjaellands Hospital
- Investigators
- Peter Lommer Kristensen, MD, PhD, Principal investigator, Copenhagen University Hospital - North Zealand, Department of Endocrinology and Nephrology, DenmarkKatrine Bagge Hansen, MD, PhD, Principal investigator, Copenhagen University Hospital - Herlev-Gentofte, Steno Diabetes Center Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803473
- Sponsor's protocol ID
- 2301240
- Acronym
- DIATEC
- Status last verified
- Mar 2024
- First submitted
- 14 Mar 2023
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: If required by medical journal to which articles are planned to be submitted or by request to corresponding author.
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.
PubMed 11889147Kristensen 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.
PubMed 34851255Akiboye 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.
PubMed 33783872Swanson 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.
PubMed 21550947Thabit 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.
PubMed 24267153Olsen 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.
PubMed 35264139Baker 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.
PubMed 16449265Dhatariya 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.
PubMed 36256494Klarskov 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.
PubMed 34524009Seisa 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.
PubMed 35690929Olsen MT, Hansen KB, Pedersen-Bjergaard U, Kristensen PL. Time at High Risk of Hypoglycemia: Validation of a Consensus-Based Continuous Glucose Monitoring-Metric for Hospitalized Patients. J Diabetes Sci Technol. 2026 Sep;20(5):1630-1635. doi: 10.1177/19322968251331600. Epub 2025 Apr 11.
PubMed 40219621Olsen 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.
PubMed 38711112
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial
- ClinicalTrials.gov ID
- NCT05803473
- Acronym / sponsor ID
- DIATEC / 2301240
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Inpatient, Randomised controlled trial, Hyperglycemia, Hypoglycemia, Glycemic variabiity, Continuous glucose monitoring, CGM, In-hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Peter KristensenUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an investigator-initiated, two-site, prospective randomised open-label blinded endpoint (PROBE) trial.
| Arm | Type | Receives |
|---|---|---|
| POC-arm | Active comparator | Device: FreeStyle Precision Pro Glucometer for glucose POC testingSubjects 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. |
| CGM-arm | Experimental | Device: Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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". | Device | CGM-arm |
| FreeStyle Precision Pro Glucometer for glucose POC testingFor the POC-arm subjects, glucose assessment is done by standard ward glucometer. | Device | POC-arm |
Primary outcome
Time in range
Time frame: During hospitalization (up to 30 days)
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.
12 secondary outcomes
Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL)
Time frame: During hospitalization (up to 30 days)
Time above range (TAR) >10.0 mmol/L (>180 mg/dL)
Time frame: During hospitalization (up to 30 days)
Time above range (TAR) >13.9 mmol/L (>250 mg/dL)
Time frame: During hospitalization (up to 30 days)
Time below range (TBR) <3.9 mmol/L (<70 mg/dL)
Time frame: During hospitalization (up to 30 days)
Time below range (TBR) <3.0 (<54 mg/dL)
Time frame: During hospitalization (up to 30 days)
Standard deviation (SD) of all CGM glucose levels
Time frame: During hospitalization (up to 30 days)
Coefficient of variation (CV)
Time frame: During hospitalization (up to 30 days)
Mean glucose levels
Time frame: During hospitalization (up to 30 days)
Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)
Time frame: During hospitalization (up to 30 days)
Hypoglycemia (level 1) 3.0-3.8 mmol/L (54-69 mg/dL)
Time frame: During hospitalization (up to 30 days)
Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)
Time frame: During hospitalization (up to 30 days)
Recurrent hypoglycemic events
Time frame: During hospitalization (up to 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 11889147Umpierrez 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.
- Background: PubMed 34851255Kristensen 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.
- Background: PubMed 33783872Akiboye 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.
- Background: PubMed 21550947Swanson 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.
- Background: PubMed 24267153Thabit 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.
- Background: PubMed 35264139Olsen 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.
- Background: PubMed 16449265Baker 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.
- Background: PubMed 36256494Dhatariya 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.
- Background: PubMed 34524009Klarskov 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.
- Background: PubMed 35690929Seisa 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.
- Derived from this study: PubMed 40219621Olsen MT, Hansen KB, Pedersen-Bjergaard U, Kristensen PL. Time at High Risk of Hypoglycemia: Validation of a Consensus-Based Continuous Glucose Monitoring-Metric for Hospitalized Patients. J Diabetes Sci Technol. 2026 Sep;20(5):1630-1635. doi: 10.1177/19322968251331600. Epub 2025 Apr 11.
- Derived from this study: PubMed 38711112Olsen 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.
- Individual participant dataSharing planned: Yes. If required by medical journal to which articles are planned to be submitted or by request to corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lommer Kristensen, MD, PhD principal investigator
Copenhagen University Hospital - North Zealand, Department of Endocrinology and Nephrology, Denmark
Katrine Bagge Hansen, MD, PhD principal investigator
Copenhagen University Hospital - Herlev-Gentofte, Steno Diabetes Center Copenhagen, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA) and FreeStyle Precision Pro Glucometer for glucose POC testing in people with Diabetes Mellitus, Type 2, run by Peter Kristensen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: During hospitalization (up to 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803473, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.