Steno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.

Steno Diabetes Centers

Status: Completed

Conditions: Type 2 Diabetes Treated With Insulin

Treatments: Behavioral: training course; Device: CGM; Behavioral: Peer-support

Study type: Interventional

Funder types: Other

Identifiers

NCT04331444

Steno2tech CGM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 3 patient groups

Group A, CGM

Experimental group

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.

Treatment:

Behavioral: training course

Device: CGM

Group B, CGM + peer-support

Experimental group

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.

Treatment:

Behavioral: training course

Behavioral: Peer-support

Device: CGM

Group C, SMBG

Active Comparator group

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.

Treatment:

Behavioral: training course