Back to resultsSteno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.
Primary Purpose
Type 2 Diabetes Treated With Insulin
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CGM
training course
Peer-support
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Treated With Insulin focused on measuring Type 2 diabetes, Continuous glucose monitoring, Insulin-treated, RCT
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes according to clinical definitions
- Treated with insulin injections at least once daily on top of diet and exercise recommendations. Insulin therapy has been used for at least 12 months. Can be additionally treated with one or more different oral antidiabetic drugs (except sulfonylurea), and/or glucagon-like-peptide 1 (GLP-1) analogues
- Attending the outpatient clinic at Steno Diabetes Center Copenhagen for at least 12 months
- Age ≥ 18 years
- HbA1c > 58 mmol/mol (7.5%) at two consecutively measurements over at least 3 months
- Willing to use possible interventions; to perform self-monitoring of blood glucose (SMBG) as requested by the investigators AND to use CGM continuously without calibration for a 12-month period.
- Willing to intensify non-medical and medical treatment to achieve better glucose control.
Exclusion Criteria:
- Inability to understand the patient information and give informed consent
- Not speaking and understanding Danish
- Treatment with sulfonylurea (SU) during the last 3 months before study start
- New antidiabetic treatment the last three months
- Use of systematic corticosteroids
- Visual impairment
- Severe skin allergy for adhesive tape to the patch of CGM or other skin condition that inhibits the use of a CGM device
- Comorbidity which does not allow lowering of HbA1c to 53 mmol/mol (7.0%)
- Hypoglycemic unawareness
- Impaired renal disease with eGFR < 45 ml/min/1.73m2
- Conditions that impact the stability of a HbA1c measurement (chronic liver disease, haemoglobinopathy, anemia etc.)
- Known or suspected alcohol or drug abuse
- Already using Flash glucose monitoring (Libre) or CGM
- Enrolled in another clinical study
- Pregnancy, intend to become pregnant, breastfeeding or not using adequate contraceptive methods
Sites / Locations
- Steno Diabetes Center Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group A, CGM
Group B, CGM + peer-support
Group C, SMBG
Arm Description
Addition of a calibration free real-time CGM in 12 months in persons with type 2 diabetes treated with insulin. The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly. Furthermore, participants in group A (intervention) will, in similarity to the HCPs, receive a CGM-education and training session led by the study investigator and will be interactive and hands-on, using case studies. The training session will include spoken and written instructions on how to insert and wear the CGM device and how to interpret the CGM information to better understand the relation between participants blood glucose and their diabetes self-management.
Addition of a calibration free real-time CGM in 12 months in persons with type 2 diabetes treated with insulin plus 3 sessions of peer-support in groups of 6 participants. The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly. Furthermore, participants in group B (intervention incl. peer-support) will, in similarity to group A, receive a CGM-education and training session. The training and CGM-course for participants in group B are similar to the course for group A with the addition of three peer-support sessions. The approach will be participatory and adaptable to allow flexibility in the content of the peer-support sessions and involving customized use of participatory methods i.e. dialogue tools and exercises.
Standard self-monitoring of blood glucose according to standard guidelines, in 12 months. The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly.
Outcomes
Primary Outcome Measures
Difference between change in TIR (3.9-10 mmol/l) in percent, assessed via blinded CGM device, between CGM group (A) and SMBG group (C)
Percent
Secondary Outcome Measures
Difference between change in HbA1c between the CGM group (A) and the SMBG group (C)
mmol/mol
Difference between change in mean sensor glucose concentration measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)
mmol/l
Difference between change in time below range (TBR) (< 3.9 mmol/l, < 3.0 mmol/l), in percent, measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)
Percent
Difference between change in time above range (TAR) (>10 mmol/l, > 13.9 mmol/l), in percent, measured by 2 weeks blinded CGM, between the CGM group (A) and the SMBG group (C)
Percent
Difference between change in glycemic variability (SD, Coefficient of variance and others), measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)
Percent
Difference between change in number of severe hypoglycemic episodes between the CGM group (A) and the SMBG group (C)
number
Difference between change in insulin dose between the CGM group (A) and the SMBG group (C)
units
Difference between change in BMI between the CGM group (A) and the SMBG group (C)
weight and height will be combined to report BMI in kg/m^2
Difference between change in antidiabetic medicine between the CGM group (A) and the SMBG group (C)
(new medication, change in doses, discontinuation of medicine)
Difference between change in patients related outcome measures on general wellbeing, between the CGM group (A) and the SMBG group (C)
measured by the questionnaire WHO-5
Difference between change in patients related outcome measures on diabetes-related distress, between the CGM group (A) and the SMBG group (C)
measured by the Diabetes Distress Scale
Difference between change in patients related outcome measures on hypoglycemia fear between the CGM group (A) and the SMBG group (C)
measured by the short form Hypoglycemia Fear Survey
Difference between change in patients related outcome measures on diabetes treatment satisfaction between the CGM group (A) and the SMBG group (C)
measured by the Diabetes Treatment Satisfaction Quenstionnaire
Difference between change in patients related outcome measures on satisfaction with glucose monitor between the CGM group (A) and the SMBG group (C)
measured by the Glucose Monitoring Satisfaction Scale
Difference between change in health behavior regarding exercise between the CGM group (A) and the SMBG group (C)
measured by the Swedish National Board of Health and Welfare questionnaire for Physical Activity
Difference between change in health behavior regarding diet between the CGM group (A) and the SMBG group (C)
measured by the Danish Perceived Dietary Adherence questionnaire
Difference between change in health behavior regarding anti-diabetic medication adherence between the CGM group (A) and the SMBG group (C)
measured by the Danish Medical Adherence Scale
Difference between change in TIR, assessed by 2 weeks blinded CGM device, and HbA1c between the CGM groups (without peer-support group A and with peer-support group B)
Percent
Difference between change in general wellbeing between the CGM groups (without peer-support group A and with peer-support group B)
measured by the questionnaire WHO-5
Difference between change in diabetes-related distress between the CGM groups (without peer-support group A and with peer-support group B)
measured by the Diabetes Distress Scale
Difference between change in hypoglycemia fear between the CGM groups (without peer-support group A and with peer-support group B)
measured by the short form Hypoglycemia Fear Survey
Difference between change in glucose monitoring satisfaction between the CGM groups (without peer-support group A and with peer-support group B)
measured by the Glucose Monitoring Satisfaction Scale
Difference between change in diabetes treatment satisfaction between the CGM groups (without peer-support group A and with peer-support group B)
measured by the Diabetes Treatment Satisfaction Quenstionnaire
Difference between change in health behavior regarding exercise between the CGM groups (without peer-support group A and with peer-support group B)
measured by the Swedish National Board of Health and Welfare questionnaire for Physical Activity
Difference between change in health behavior regarding diet between the CGM groups (without peer-support group A and with peer-support group B)
measured by the Danish Perceived Dietary Adherence questionnaire
Difference between change in health behavior regarding anti-diabetic medication adherence between the CGM groups (without peer-support group A and with peer-support group B)
measured by the Danish Medical Adherence Scale
Difference in mean number of days of CGM use between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
days
Difference in HbA1c baseline between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
mmol/mol
Difference in age between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
in years
Difference in diabetes duration between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
in years
Difference in C-peptide between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
pmol/l
Difference in education level between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Percent
Difference in social status between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
measured by civil status and occupation
Difference in ethnicity between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
white/non-white
Difference in medicine used between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Difference in change in health behavior regarding to diet between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
measured by the Danish Perceived Dietary Adherence questionnaire
Difference in change in health behavior regarding to exercise between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
measured by the Swedish National Board of Health and Welfare questionnaire for Physical Activity
Difference in change in health behavior regarding to medication adherence between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
measured by the Danish Medical Adherence Scale
Correlation between mean number of SMBG/day and time points for SMBG in the study period and improvement in HbA1c, in TIR, in TBR, in TAR within the control group C
Difference between number of participants using CGM vs. not using CGM increasing 5 % or more in TIR
number
Full Information
NCT ID
NCT04331444
First Posted
March 26, 2020
Last Updated
October 11, 2023
Sponsor
Steno Diabetes Center Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT04331444
Brief Title
Steno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.
Official Title
Steno2tech CGM-The Effect of Real-time Continuous Glucose Monitoring vs. Self-monitoring of Blood Glucose on Glycemic Variables and Patient Reported Outcomes in Adults With Type 2 Diabetes Treated With Insulin-A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steno Diabetes Center Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall objective of this research study is to examine the effectiveness of the use of CGM vs. SMBG in persons with insulin-treated type 2 diabetes on glycemic variables and patient reported outcomes on treatment satisfaction, health behavior and wellbeing. The independent effect of peer-support will also be studied.
Detailed Description
The prevalence of type 2 diabetes is increasing. Although medical treatment options have increased, still less than a third obtain their optimal glycemic goal. The use of continuous glucose monitoring (CGM) in persons with type 1 diabetes has shown to be the most important driver for improvement in glycemic control-even more than insulin-pump therapy-but the use of technology in type 2 diabetes are not yet reimbursed and has been investigated in very few studies.
The study will be a single center, prospective, randomized, open-labelled, three-armed study with the randomization 2:1:2 in group A with CGM, group B with CGM and peer-support, group C as a control group with SMBG. The study will run for 12 months and will include 100 adult participants with insulin-treated type 2 diabetes, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Recruitment will begin in August 2020 and end in May 2022. Final 12-month follow-up is anticipated to be in July 2023.
The study is investor-initiated. The primary investigator (Nanna Lind, PhD. Student) will be responsible for execution of this study under guidance by the sponsor Kirsten Nørgaard. Results will be published in international peer-reviewed journals.
Our study will provide evidence of the effectiveness of the use of CGM in the treatment for type 2 diabetes, potentially shaping clinical guidelines for SMBG frequency and timing as well as use of technology in type 2 diabetes with an impact on both healthcare and healthcare costs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Treated With Insulin
Keywords
Type 2 diabetes, Continuous glucose monitoring, Insulin-treated, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A, CGM
Arm Type
Experimental
Arm Description
Addition of a calibration free real-time CGM in 12 months in persons with type 2 diabetes treated with insulin.
The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly. Furthermore, participants in group A (intervention) will, in similarity to the HCPs, receive a CGM-education and training session led by the study investigator and will be interactive and hands-on, using case studies. The training session will include spoken and written instructions on how to insert and wear the CGM device and how to interpret the CGM information to better understand the relation between participants blood glucose and their diabetes self-management.
Arm Title
Group B, CGM + peer-support
Arm Type
Experimental
Arm Description
Addition of a calibration free real-time CGM in 12 months in persons with type 2 diabetes treated with insulin plus 3 sessions of peer-support in groups of 6 participants.
The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly. Furthermore, participants in group B (intervention incl. peer-support) will, in similarity to group A, receive a CGM-education and training session. The training and CGM-course for participants in group B are similar to the course for group A with the addition of three peer-support sessions. The approach will be participatory and adaptable to allow flexibility in the content of the peer-support sessions and involving customized use of participatory methods i.e. dialogue tools and exercises.
Arm Title
Group C, SMBG
Arm Type
Active Comparator
Arm Description
Standard self-monitoring of blood glucose according to standard guidelines, in 12 months.
The participants will participate in a training course that will include the influence of different food items and exercise on glucose levels, how to measure SMBG correctly.
Intervention Type
Device
Intervention Name(s)
CGM
Other Intervention Name(s)
Continuous glucose monitoring
Intervention Description
Using the CGM during the entire study period of 12 months.
Intervention Type
Behavioral
Intervention Name(s)
training course
Intervention Description
The participants in the three groups will attend a three-hour training course with different content depending on the group allocation. The aim of this training course is to ensure that the participants have the knowledge, support and confidence to work collaboratively with their HCPs to increase TIR and decrease HbA1c.
Intervention Type
Behavioral
Intervention Name(s)
Peer-support
Other Intervention Name(s)
Group sessions
Intervention Description
The peer-support will be facilitator-led by the primary investigator with peer exchange in group sessions (3 sessions over the study period, 3 hours per session) with 6-8 participants in every group.
Primary Outcome Measure Information:
Title
Difference between change in TIR (3.9-10 mmol/l) in percent, assessed via blinded CGM device, between CGM group (A) and SMBG group (C)
Description
Percent
Time Frame
from baseline to 12 months
Secondary Outcome Measure Information:
Title
Difference between change in HbA1c between the CGM group (A) and the SMBG group (C)
Description
mmol/mol
Time Frame
from baseline to 12 months
Title
Difference between change in mean sensor glucose concentration measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)
Description
mmol/l
Time Frame
from baseline to 12 months
Title
Difference between change in time below range (TBR) (< 3.9 mmol/l, < 3.0 mmol/l), in percent, measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)
Description
Percent
Time Frame
from baseline to 12 months
Title
Difference between change in time above range (TAR) (>10 mmol/l, > 13.9 mmol/l), in percent, measured by 2 weeks blinded CGM, between the CGM group (A) and the SMBG group (C)
Description
Percent
Time Frame
from baseline to 12 months
Title
Difference between change in glycemic variability (SD, Coefficient of variance and others), measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)
Description
Percent
Time Frame
from baseline to 12 months
Title
Difference between change in number of severe hypoglycemic episodes between the CGM group (A) and the SMBG group (C)
Description
number
Time Frame
from baseline to 12 months
Title
Difference between change in insulin dose between the CGM group (A) and the SMBG group (C)
Description
units
Time Frame
from baseline to 12 months
Title
Difference between change in BMI between the CGM group (A) and the SMBG group (C)
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
from baseline to 12 months
Title
Difference between change in antidiabetic medicine between the CGM group (A) and the SMBG group (C)
Description
(new medication, change in doses, discontinuation of medicine)
Time Frame
from baseline to 12 months
Title
Difference between change in patients related outcome measures on general wellbeing, between the CGM group (A) and the SMBG group (C)
Description
measured by the questionnaire WHO-5
Time Frame
from baseline to 12 months
Title
Difference between change in patients related outcome measures on diabetes-related distress, between the CGM group (A) and the SMBG group (C)
Description
measured by the Diabetes Distress Scale
Time Frame
from baseline to 12 months
Title
Difference between change in patients related outcome measures on hypoglycemia fear between the CGM group (A) and the SMBG group (C)
Description
measured by the short form Hypoglycemia Fear Survey
Time Frame
from baseline to 12 months
Title
Difference between change in patients related outcome measures on diabetes treatment satisfaction between the CGM group (A) and the SMBG group (C)
Description
measured by the Diabetes Treatment Satisfaction Quenstionnaire
Time Frame
from baseline to 12 months
Title
Difference between change in patients related outcome measures on satisfaction with glucose monitor between the CGM group (A) and the SMBG group (C)
Description
measured by the Glucose Monitoring Satisfaction Scale
Time Frame
from baseline to 12 months
Title
Difference between change in health behavior regarding exercise between the CGM group (A) and the SMBG group (C)
Description
measured by the Swedish National Board of Health and Welfare questionnaire for Physical Activity
Time Frame
from baseline to 12 months
Title
Difference between change in health behavior regarding diet between the CGM group (A) and the SMBG group (C)
Description
measured by the Danish Perceived Dietary Adherence questionnaire
Time Frame
from baseline to 12 months
Title
Difference between change in health behavior regarding anti-diabetic medication adherence between the CGM group (A) and the SMBG group (C)
Description
measured by the Danish Medical Adherence Scale
Time Frame
from baseline to 12 months
Title
Difference between change in TIR, assessed by 2 weeks blinded CGM device, and HbA1c between the CGM groups (without peer-support group A and with peer-support group B)
Description
Percent
Time Frame
from baseline to 12 months
Title
Difference between change in general wellbeing between the CGM groups (without peer-support group A and with peer-support group B)
Description
measured by the questionnaire WHO-5
Time Frame
from baseline to 12 months
Title
Difference between change in diabetes-related distress between the CGM groups (without peer-support group A and with peer-support group B)
Description
measured by the Diabetes Distress Scale
Time Frame
from baseline to 12 months
Title
Difference between change in hypoglycemia fear between the CGM groups (without peer-support group A and with peer-support group B)
Description
measured by the short form Hypoglycemia Fear Survey
Time Frame
from baseline to 12 months
Title
Difference between change in glucose monitoring satisfaction between the CGM groups (without peer-support group A and with peer-support group B)
Description
measured by the Glucose Monitoring Satisfaction Scale
Time Frame
from baseline to 12 months
Title
Difference between change in diabetes treatment satisfaction between the CGM groups (without peer-support group A and with peer-support group B)
Description
measured by the Diabetes Treatment Satisfaction Quenstionnaire
Time Frame
from baseline to 12 months
Title
Difference between change in health behavior regarding exercise between the CGM groups (without peer-support group A and with peer-support group B)
Description
measured by the Swedish National Board of Health and Welfare questionnaire for Physical Activity
Time Frame
from baseline to 12 months
Title
Difference between change in health behavior regarding diet between the CGM groups (without peer-support group A and with peer-support group B)
Description
measured by the Danish Perceived Dietary Adherence questionnaire
Time Frame
from baseline to 12 months
Title
Difference between change in health behavior regarding anti-diabetic medication adherence between the CGM groups (without peer-support group A and with peer-support group B)
Description
measured by the Danish Medical Adherence Scale
Time Frame
from baseline to 12 months
Title
Difference in mean number of days of CGM use between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
days
Time Frame
from baseline to 12 months
Title
Difference in HbA1c baseline between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
mmol/mol
Time Frame
from baseline to 12 months
Title
Difference in age between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
in years
Time Frame
from baseline to 12 months
Title
Difference in diabetes duration between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
in years
Time Frame
from baseline to 12 months
Title
Difference in C-peptide between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
pmol/l
Time Frame
from baseline to 12 months
Title
Difference in education level between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
Percent
Time Frame
from baseline to 12 months
Title
Difference in social status between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
measured by civil status and occupation
Time Frame
from baseline to 12 months
Title
Difference in ethnicity between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
white/non-white
Time Frame
from baseline to 12 months
Title
Difference in medicine used between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Time Frame
from baseline to 12 months
Title
Difference in change in health behavior regarding to diet between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
measured by the Danish Perceived Dietary Adherence questionnaire
Time Frame
from baseline to 12 months
Title
Difference in change in health behavior regarding to exercise between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
measured by the Swedish National Board of Health and Welfare questionnaire for Physical Activity
Time Frame
from baseline to 12 months
Title
Difference in change in health behavior regarding to medication adherence between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
Description
measured by the Danish Medical Adherence Scale
Time Frame
from baseline to 12 months
Title
Correlation between mean number of SMBG/day and time points for SMBG in the study period and improvement in HbA1c, in TIR, in TBR, in TAR within the control group C
Time Frame
from baseline to 12 months
Title
Difference between number of participants using CGM vs. not using CGM increasing 5 % or more in TIR
Description
number
Time Frame
from baseline to 12 months
Other Pre-specified Outcome Measures:
Title
Evaluating which blood glucose measured by SMBG best reflect TIR
Description
(fasting, pre-prandial or postprandial)
Time Frame
from baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes according to clinical definitions
Treated with insulin injections at least once daily on top of diet and exercise recommendations. Insulin therapy has been used for at least 12 months. Can be additionally treated with one or more different oral antidiabetic drugs (except sulfonylurea), and/or glucagon-like-peptide 1 (GLP-1) analogues
Attending the outpatient clinic at Steno Diabetes Center Copenhagen for at least 12 months
Age ≥ 18 years
HbA1c > 58 mmol/mol (7.5%) at two consecutively measurements over at least 3 months
Willing to use possible interventions; to perform self-monitoring of blood glucose (SMBG) as requested by the investigators AND to use CGM continuously without calibration for a 12-month period.
Willing to intensify non-medical and medical treatment to achieve better glucose control.
Exclusion Criteria:
Inability to understand the patient information and give informed consent
Not speaking and understanding Danish
Treatment with sulfonylurea (SU) during the last 3 months before study start
New antidiabetic treatment the last three months
Use of systematic corticosteroids
Visual impairment
Severe skin allergy for adhesive tape to the patch of CGM or other skin condition that inhibits the use of a CGM device
Comorbidity which does not allow lowering of HbA1c to 53 mmol/mol (7.0%)
Hypoglycemic unawareness
Impaired renal disease with eGFR < 45 ml/min/1.73m2
Conditions that impact the stability of a HbA1c measurement (chronic liver disease, haemoglobinopathy, anemia etc.)
Known or suspected alcohol or drug abuse
Already using Flash glucose monitoring (Libre) or CGM
Enrolled in another clinical study
Pregnancy, intend to become pregnant, breastfeeding or not using adequate contraceptive methods
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanna Lind, RN MSc
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Gentofte
State/Province
Hovedstaden
ZIP/Postal Code
2820
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study results, positive, negative and inconclusive findings, will be presented at national and international scientific meetings and published in at least three scientific papers in international scientific peer-reviewed journals and through the PhD thesis. After conclusion of the study, a final report will be generated and sent to the Regional Scientific Ethics Committee (RVK). The study protocol will furthermore be published at www.clinicaltrial.gov.
Citations:
PubMed Identifier
33452188
Citation
Lind N, Lindqvist Hansen D, Saetre Rasmussen S, Norgaard K. Real-time continuous glucose monitoring versus self-monitoring of blood glucose in adults with insulin-treated type 2 diabetes: a protocol for a randomised controlled single-centre trial. BMJ Open. 2021 Jan 15;11(1):e040648. doi: 10.1136/bmjopen-2020-040648.
Results Reference
derived
Learn more about this trial
Steno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.
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