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Type 2 Diabetes Treated With InsulinNCT04331444

Steno2tech - Continuous Glucose Monitoring and Type 2 Diabetes.

A study testing CGM, training course and Peer-support in people with Type 2 Diabetes Treated With Insulin, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Treated With Insulin
What is being tested?
CGM, training course and Peer-support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteDenmark
Study dates
1 Aug 2020to 1 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center Copenhagen

    Gentofte Municipality, Capital Region, 2820

Other trials in Denmark

About this study

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.

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.

Read the 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.

Being tested
CGM, training course, Peer-support
Keywords
Type 2 diabetes, Continuous glucose monitoring, Insulin-treated, RCT
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGMDevice

    Also called Continuous glucose monitoring

    Using the CGM during the entire study period of 12 months.

  • training courseBehavioural

    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-supportBehavioural

    Also called Group sessions

    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.

Study groups in NCT04331444
Study groupRoleWhat they receive
Group A, CGMExperimentalAddition 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.
Receives: Device: CGM; Behavioral: training course
Group B, CGM + peer-supportExperimentalAddition 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.
Receives: Device: CGM; Behavioral: training course; Behavioral: Peer-support
Group C, SMBGActive comparatorStandard 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.
Receives: Behavioral: training course

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: from baseline to 12 months

Secondary outcomes (40)

  1. Difference between change in HbA1c between the CGM group (A) and the SMBG group (C)

    mmol/mol

    Measured: from baseline to 12 months

  2. 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

    Measured: from baseline to 12 months

  3. 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

    Measured: from baseline to 12 months

  4. 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

    Measured: from baseline to 12 months

  5. 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

    Measured: from baseline to 12 months

  6. Difference between change in number of severe hypoglycemic episodes between the CGM group (A) and the SMBG group (C)

    number

    Measured: from baseline to 12 months

  7. Difference between change in insulin dose between the CGM group (A) and the SMBG group (C)

    units

    Measured: from baseline to 12 months

  8. 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

    Measured: from baseline to 12 months

  9. Difference between change in antidiabetic medicine between the CGM group (A) and the SMBG group (C)

    (new medication, change in doses, discontinuation of medicine)

    Measured: from baseline to 12 months

  10. 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

    Measured: from baseline to 12 months

  11. 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

    Measured: from baseline to 12 months

  12. 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

    Measured: from baseline to 12 months

  13. 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

    Measured: from baseline to 12 months

  14. 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

    Measured: from baseline to 12 months

  15. 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

    Measured: from baseline to 12 months

  16. 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

    Measured: from baseline to 12 months

  17. 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

    Measured: from baseline to 12 months

  18. 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

    Measured: from baseline to 12 months

  19. 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

    Measured: from baseline to 12 months

  20. 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

    Measured: from baseline to 12 months

  21. 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

    Measured: from baseline to 12 months

  22. 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

    Measured: from baseline to 12 months

  23. 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

    Measured: from baseline to 12 months

  24. 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

    Measured: from baseline to 12 months

  25. 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

    Measured: from baseline to 12 months

  26. 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

    Measured: from baseline to 12 months

  27. 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

    Measured: from baseline to 12 months

  28. Difference in HbA1c baseline between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)

    mmol/mol

    Measured: from baseline to 12 months

  29. Difference in age between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)

    in years

    Measured: from baseline to 12 months

  30. Difference in diabetes duration between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)

    in years

    Measured: from baseline to 12 months

  31. Difference in C-peptide between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)

    pmol/l

    Measured: from baseline to 12 months

  32. Difference in education level between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)

    Percent

    Measured: from baseline to 12 months

  33. 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

    Measured: from baseline to 12 months

  34. Difference in ethnicity between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)

    white/non-white

    Measured: from baseline to 12 months

  35. Difference in medicine used between individuals achieving TIR> 70% vs TIR< 70% within the CGM groups (group A+B)

    Measured: from baseline to 12 months

  36. 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

    Measured: from baseline to 12 months

  37. 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

    Measured: from baseline to 12 months

  38. 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

    Measured: from baseline to 12 months

  39. 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

    Measured: from baseline to 12 months

  40. Difference between number of participants using CGM vs. not using CGM increasing 5 % or more in TIR

    number

    Measured: from baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04331444
Sponsor's protocol ID
Steno2tech CGM
Status last verified
Oct 2023
First submitted
26 Mar 2020
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 33452188

Questions about this trial

What is this clinical trial studying?

A study testing CGM, training course and Peer-support in people with Type 2 Diabetes Treated With Insulin, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: from baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04331444, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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