Status:
COMPLETED
Steno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Type 2 Diabetes Treated With Insulin
Eligibility:
All Genders
18+ years
Phase:
NA
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 outco...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04331444
Start Date
August 1 2020
End Date
July 1 2023
Last Update
October 12 2023
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Gentofte Municipality, Capital Region, Denmark, 2820