Steno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.
NCT ID: NCT04331444
Last Updated: 2023-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2020-08-01
2023-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A, CGM
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.
CGM
Using the CGM during the entire study period of 12 months.
training course
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.
Group B, CGM + peer-support
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.
CGM
Using the CGM during the entire study period of 12 months.
training course
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.
Peer-support
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.
Group C, SMBG
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.
training course
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.
Interventions
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CGM
Using the CGM during the entire study period of 12 months.
training course
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.
Peer-support
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Nanna Lind
RN, MSc. in nursing
Principal Investigators
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Nanna Lind, RN MSc
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Copenhagen
Locations
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Steno Diabetes Center Copenhagen
Gentofte Municipality, Capital Region, Denmark
Countries
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References
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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.
Other Identifiers
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Steno2tech CGM
Identifier Type: -
Identifier Source: org_study_id
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