Clinical trial NCT04331444: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: Type 2 diabetes
Continuous glucose monitoring
Insulin-treated
RCT
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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)
timeFrame: from baseline to 12 months
Secondary outcomes:
measure: Difference between change in HbA1c between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in mean sensor glucose concentration measured by 2 weeks blinded CGM between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: 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)
timeFrame: from baseline to 12 months
measure: 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)
timeFrame: from baseline to 12 months
measure: 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)
timeFrame: from baseline to 12 months
measure: Difference between change in number of severe hypoglycemic episodes between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in insulin dose between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in BMI between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in antidiabetic medicine between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in patients related outcome measures on general wellbeing, between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in patients related outcome measures on diabetes-related distress, between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in patients related outcome measures on hypoglycemia fear between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in patients related outcome measures on diabetes treatment satisfaction between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in patients related outcome measures on satisfaction with glucose monitor between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in health behavior regarding exercise between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in health behavior regarding diet between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: Difference between change in health behavior regarding anti-diabetic medication adherence between the CGM group (A) and the SMBG group (C)
timeFrame: from baseline to 12 months
measure: 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)
timeFrame: from baseline to 12 months
measure: Difference between change in general wellbeing between the CGM groups (without peer-support group A and with peer-support group B)
timeFrame: from baseline to 12 months
measure: Difference between change in diabetes-related distress between the CGM groups (without peer-support group A and with peer-support group B)
timeFrame: from baseline to 12 months
measure: Difference between change in hypoglycemia fear between the CGM groups (without peer-support group A and with peer-support group B)
timeFrame: from baseline to 12 months
measure: Difference between change in glucose monitoring satisfaction between the CGM groups (without peer-support group A and with peer-support group B)
timeFrame: from baseline to 12 months
measure: Difference between change in diabetes treatment satisfaction between the CGM groups (without peer-support group A and with peer-support group B)
timeFrame: from baseline to 12 months
measure: Difference between change in health behavior regarding exercise between the CGM groups (without peer-support group A and with peer-support group B)
timeFrame: from baseline to 12 months
measure: Difference between change in health behavior regarding diet between the CGM groups (without peer-support group A and with peer-support group B)
timeFrame: from baseline to 12 months
measure: 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)
timeFrame: from baseline to 12 months
measure: Difference in mean number of days of CGM use between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in HbA1c baseline between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in age between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in diabetes duration between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in C-peptide between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in education level between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in social status between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in ethnicity between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in medicine used between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in change in health behavior regarding to diet between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: Difference in change in health behavior regarding to exercise between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)
timeFrame: from baseline to 12 months
measure: 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)
timeFrame: from baseline to 12 months
measure: 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
timeFrame: from baseline to 12 months
measure: Difference between number of participants using CGM vs. not using CGM increasing 5 % or more in TIR
timeFrame: from baseline to 12 months
Other outcomes:
measure: Evaluating which blood glucose measured by SMBG best reflect TIR
timeFrame: from baseline to 12 months
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
state: Hovedstaden
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Nanna Lind, RN MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.