Type 2 Diabetes Treated With InsulinDia2techNCT06311019
The Effects of CGM and Connected Pen in T2DM Treated With Multiple Daily Insulin Injections
A study testing Continuous glucose monitoring and use of connected insulinpen for bolus insulin in people with Type 2 Diabetes Treated With Insulin, run by Klavs Würgler Hansen at 5 sites in Denmark.
Trial summary
The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c >53 mmol/mol (7. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- Continuous glucose monitoring and use of connected insulinpen for bolus insulin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 5 sitesDenmark
- Study dates
- 27 Feb 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Type 2 DM.
- - HbA1c > 53 mmol/l (7.0 %, estimated average glucose (eAG) 8.6 mmol/l).
- - Contact to diabetes clinic for ≥ 6 months.
- - Insulin treatment ≥ 12 months.
- - Basal insulin and bolus insulin at least for one meal every day.
- - Bolus insulin is insulin aspart.
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- - Stable insulin treatment (change 10 % or less) and no introduction of other antihyperglycemic agents (oral or GLP1 analogue) for at least 2 months before randomization.
- - Considered to be technically and intellectually capable of using isCGM and smart pen.
- - Can communicate in Danish.
- - Informed consent including acceptance to share glucose data from the Libreview platforms.
- - The patient has a smart phone suitable for Libre and NOVOpen6 data registration.
Who cannot join
- - Individual goal for HbA1c is reached (even if > 53 mmol/mol), i.e. relaxed treatment goals as relevant for fragile patients with severe diabetic complications or comorbidities.
- - Fasting C-peptide < 370 pmol/l.
- - Actual treatment with CGM or previous use of CGM for more than four weeks or < 6 months before recruitment. No actual or previous use of connected pen.
- - One or more severe hypoglycemic episode (assistance of third party) within the previous 12 months.
- - Considered unable to participate due to frequent cancellation of appointments.
- - Ongoing steroid treatment or expected intermittent treatment of more than 14 days' duration.
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- - Pregnant or planning pregnancy.
- - Participating in other trials.
- - Clinical conditions interfering with interpretation of HbA1c (phlebectomy, bleeding or haemolytic disorders, erythropoietin treatment, known haemoglobin variants, etc.) or continuous intake of high dose of vitamin C (> 1000 mg), salicylic acid (650 mg daily), Salazopyrin or Dapsone.
- - Allergic reaction to the adhesive used in the isCGM.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Steno Diabetes Center Aarhus
Aarhus, 8000
Gødstrup Regional Hospital
Herning, 7400
Horsens Regional Hospital
Horsens, 8700
Randers Regional Hospital
Randers, 8900
Regional Hospital Silkeborg, Central Jutland Hospital
Silkeborg, 8600
About this study
Official title: The Effects of Continuous Glucose Monitoring and Connected Insulin Pens on Glycemic Control in Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections.
The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c >53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care.
Read the detailed description
This study is a 12 months open-label randomized controlled trial.
Subjects with basal/bolus insulin treated T2DM and HbA1c >53 mmol/mol are randomized to:
A (control): standard care with disposable insulin pens and fingerprick glucose measurement or B (intervention): Novopen6 for bolus insulin and glucose measurement with Freestyle Libre 2.
Due to the nature of the treatments it is not possible to perform a blinded study.
Randomization in ratio 1:1 will be formed electronically in a REDCap database.
The investigators estimate that the mean HbA1c at baseline is 60 mmol/mol. Given a standard deviation of the difference of approximately 8.1 mmol/mol (based on in house data from 114 patients with T2DM and insulin), the investigators calculate that 47 patients are needed in each arm to detect a minimal relevant difference of 5 mmol/mol with a type I error of 5% and a type II error 15%. Allowing for 10 % dropouts, the investigators aim to recruit 52 patients in each arm. If an interim analysis 3 months after randomizing 40 patients suggest a higher drop-out rate, the study size will be increased accordingly to a drop-out rate of max. 20 % (56 in each arm).
Study plan
Pre-screening of eligible patients was performed by assessing data from the healthcare administrative electronic software platform Business Intelligence (BI) of the Central Denmark Region. In this portal, data on medication, lab results, time period for contact to outpatient clinic for persons followed in secondary healthcare are automatically registered by data capture. Data can be retrieved from the BI portal via access to an encrypted version of the civil registration numbers allocated to all Danish citizens. The investigators collected data on prescribed pharmacological treatment for all persons with Type 2 diabetes who have had a minimum of one contact to the study centers.
The electronic patient records for potential study candidates were reviewed for in- and exclusion criteria. Patients still considered study candidates after pre-screening were contacted by e-mail and invited to a meeting.
Visit 1 (- 4 weeks): Inclusion and exclusion criteria are reviewed. Orally information of the study plan provided with reflection-time up to 24 hours. Planning fasting blood sample, blinded CGM (Freestyle Libre Pro) is applied, medication reviewed. Questionnaires answered.
Visit 2 (-2 weeks): Fasting blood samples, Libre Pro removed and uploaded.
Visit 3 (0 months): Randomization if inclusion criteria are full-filled and no exclusion criteria. Otherwise considered a screening failure. Randomization to either:
A (control): continues treatment with usual insulin pens and self measurements of blood glucose.
B (intervention): changes to NovoPen 6 for bolus insulin and CGM (Abbott Freestyle Libre 2). Patients randomized to intervention will participate in a structured education programme about the clinical use of Libre 2 and Novopen 6. This also includes assistance to upload LibreLink app. on the mobile phone, to upload Novopen 6 data and to establish a Libre View account. The patients fill in the diabetes health related questionnaires.
Visit 4 Intervention group only (1 month): Telephone call (by study nurse) or optional personal meeting as necessary. Technical support only as needed for the upload of Freestyle Libre 2 and Novopen6 to LibreView.
Visit 5 (11½ months): Blinded Freestyle Libre Pro is applied to all subjects (arm A and B).
Visit 6 (12 months): Blood sample for HbA1c. Discontinuation and upload of Freestyle Libre Pro IQ (Libre view) and blood glucose-meter (Glooko)) for the last 14 days for both the control and intervention arm. In addition upload of Libre 2 and Novopen6 data (Libre view) for the last 4 weeks is performed for the intervention arm. Fill in of diabetes health related questionnaires and use of the memory function of Novopen 6
In-between study visits patients follow standard care in terms of number of visits (physical or telemedicine), type of health care provider (nurse or doctor), measurement of HbA1c and other clinical activities at the health care providers discretion, to enhance extern validity.
The glucose data is evaluated by the usual health care providers together with the patient in order to optimize insulin therapy, including an increase in the number of meals with bolus insulin if necessary.
According to the study design all patients are treated with bolus insulin for at least one meal. Bolus insulin should be insulin aspart. If patients are treated with insulin aspart manufactured by other companies than Novo Nordisk, the patients are asked to change to the biosimilar product from Novo. This strategy ensures that all patients can undergo randomization, since only Novo products fits into the Novopen6. Fast acting insulin is provided to all the patients in the study period free of charge. Patients randomized to the intervention group B receives Novopen6 free of charge.
Patients are included irrespective of the brand of basal insulin. Any other glucose lowering drug (oral or injection) can be added or discontinued during the study at the investigators discretion.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- Continuous glucose monitoring and use of connected insulinpen for bolus insulin
- Keywords
- Type 2 diabetes mellitus, Insulin, Continuous glucose monitoring, Connected Pen
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring and use of connected insulinpen for bolus insulinDevice
Continuous glucose monitoring (Abbott Freestyle Libre 2) and use of connected insulinpen (Novopen 6) for bolus insulin
| Study group | Role | What they receive |
|---|---|---|
| 1 (Standard care) | No intervention | In this arm the patients continue to measure blood glucose with fingerprick and use standard insulin pens |
| 2 (CGM and connected pen) | Active comparator | In this arm the patients switch from glucose measurement with fingerprick to continuous glucose monitoring and they switch from standard insulin pen for bolusinsulin to connected pen for bolusinsulin Receives: Device: Continuous glucose monitoring and use of connected insulinpen for bolus insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Haemoglobin A1c
Change between groups in Haemoglobin A1c (mmol/mol) from baseline to follow-up
A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
Measured: Baseline and follow-up after 12 months
Secondary outcomes (9)
Change Time in range
Change in the fraction (%) of glucose values in the range 3.9 to 10.0 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
Measured: Baseline and follow-up after 12 months
Change in Time above range
Change in The fraction (%) of glucose values in the range > 10.0 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
Measured: Baseline and follow-up after 12 months
Change in Time below range
Change in the fraction (%) of glucose values < 3.9 mmol/l, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
Measured: Baseline and follow-up after 12 months
Mean glucose
The mean of all glucose values for 14 days measured by Libre Pro IQ.
A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
Measured: Baseline and follow-up after 12 months
Standard deviation
The standard deviation of glucose values for 14 days, measured by Libre Pro IQ.
A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
Measured: Baseline and follow-up after 12 months
Change in CV
Change in the coefficient of variation (%) for glucose values for 14 days, measured by Libre Pro IQ for 14 days.
A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
Measured: Baseline and follow-up after 12 months
Change in Time with rapid glucose change
Change in the time fraction (%) with glucose rate of change > 1.5 mmol/l/15 min, measured by Libre Pro. A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
IQ for 14 days.
Measured: Baseline and follow-up after 12 months
Change in ARRC
Change in Mean of average absolute change of glucose rate (ml/mol/15 min), measured by Libre Pro IQ for 14 days. A prespecified exploratory analysis is planned for:
male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings.
A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
Measured: Baseline and follow-up after 12 months
Fraction of patients with increased number of bolus insulin per day
The fraction of patients increasing from one or two meals with bolus insulin to two or three meals with bolus insulin.
Measured: Baseline and follow-up after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start27 Feb 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klavs Würgler Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Klavs Würgler Hansen, Central Jutland Regional Hospital
- Investigators
- Klavs W Hansen, Study director, Medical Diagnostic Center, Silkeborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311019
- Sponsor's protocol ID
- 791572
- Acronym
- Dia2tech
- Status last verified
- Nov 2024
- First submitted
- 6 Feb 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data planned to make available: All primary and secondary outcome values
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Continuous Glucose Monitoring and Connected Insulin Pens on Glycemic Control in Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections.
- ClinicalTrials.gov ID
- NCT06311019
- Acronym / sponsor ID
- Dia2tech / 791572
- Conditions
- Type 2 Diabetes Treated With Insulin
- Keywords
- Type 2 diabetes mellitus, Insulin, Continuous glucose monitoring, Connected Pen
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Klavs Würgler HansenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the effect of a combination of 12 months treatment with CGM (Freestyle Libre 2) with hypo and hyper alert in combination with a smart pen for bolus insulin (NOVOpen6) on HbA1c and time in range (TIR) in T2DM patients with baseline HbA1c >53 mmol/mol (7. 0%, eAG 8,6 mmol/l) as compared with standard care.
Detailed description
This study is a 12 months open-label randomized controlled trial.
Subjects with basal/bolus insulin treated T2DM and HbA1c >53 mmol/mol are randomized to:
A (control): standard care with disposable insulin pens and fingerprick glucose measurement or B (intervention): Novopen6 for bolus insulin and glucose measurement with Freestyle Libre 2.
Due to the nature of the treatments it is not possible to perform a blinded study.
Randomization in ratio 1:1 will be formed electronically in a REDCap database.
The investigators estimate that the mean HbA1c at baseline is 60 mmol/mol. Given a standard deviation of the difference of approximately 8.1 mmol/mol (based on in house data from 114 patients with T2DM and insulin), the investigators calculate that 47 patients are needed in each arm to detect a minimal relevant difference of 5 mmol/mol with a type I error of 5% and a type II error 15%. Allowing for 10 % dropouts, the investigators aim to recruit 52 patients in each arm. If an interim analysis 3 months after randomizing 40 patients suggest a higher drop-out rate, the study size will be increased accordingly to a drop-out rate of max. 20 % (56 in each arm).
Study plan
Pre-screening of eligible patients was performed by assessing data from the healthcare administrative electronic software platform Business Intelligence (BI) of the Central Denmark Region. In this portal, data on medication, lab results, time period for contact to outpatient clinic for persons followed in secondary healthcare are automatically registered by data capture. Data can be retrieved from the BI portal via access to an encrypted version of the civil registration numbers allocated to all Danish citizens. The investigators collected data on prescribed pharmacological treatment for all persons with Type 2 diabetes who have had a minimum of one contact to the study centers.
The electronic patient records for potential study candidates were reviewed for in- and exclusion criteria. Patients still considered study candidates after pre-screening were contacted by e-mail and invited to a meeting.
Visit 1 (- 4 weeks): Inclusion and exclusion criteria are reviewed. Orally information of the study plan provided with reflection-time up to 24 hours. Planning fasting blood sample, blinded CGM (Freestyle Libre Pro) is applied, medication reviewed. Questionnaires answered.
Visit 2 (-2 weeks): Fasting blood samples, Libre Pro removed and uploaded.
Visit 3 (0 months): Randomization if inclusion criteria are full-filled and no exclusion criteria. Otherwise considered a screening failure. Randomization to either:
A (control): continues treatment with usual insulin pens and self measurements of blood glucose.
B (intervention): changes to NovoPen 6 for bolus insulin and CGM (Abbott Freestyle Libre 2). Patients randomized to intervention will participate in a structured education programme about the clinical use of Libre 2 and Novopen 6. This also includes assistance to upload LibreLink app. on the mobile phone, to upload Novopen 6 data and to establish a Libre View account. The patients fill in the diabetes health related questionnaires.
Visit 4 Intervention group only (1 month): Telephone call (by study nurse) or optional personal meeting as necessary. Technical support only as needed for the upload of Freestyle Libre 2 and Novopen6 to LibreView.
Visit 5 (11½ months): Blinded Freestyle Libre Pro is applied to all subjects (arm A and B).
Visit 6 (12 months): Blood sample for HbA1c. Discontinuation and upload of Freestyle Libre Pro IQ (Libre view) and blood glucose-meter (Glooko)) for the last 14 days for both the control and intervention arm. In addition upload of Libre 2 and Novopen6 data (Libre view) for the last 4 weeks is performed for the intervention arm. Fill in of diabetes health related questionnaires and use of the memory function of Novopen 6
In-between study visits patients follow standard care in terms of number of visits (physical or telemedicine), type of health care provider (nurse or doctor), measurement of HbA1c and other clinical activities at the health care providers discretion, to enhance extern validity.
The glucose data is evaluated by the usual health care providers together with the patient in order to optimize insulin therapy, including an increase in the number of meals with bolus insulin if necessary.
According to the study design all patients are treated with bolus insulin for at least one meal. Bolus insulin should be insulin aspart. If patients are treated with insulin aspart manufactured by other companies than Novo Nordisk, the patients are asked to change to the biosimilar product from Novo. This strategy ensures that all patients can undergo randomization, since only Novo products fits into the Novopen6. Fast acting insulin is provided to all the patients in the study period free of charge. Patients randomized to the intervention group B receives Novopen6 free of charge.
Patients are included irrespective of the brand of basal insulin. Any other glucose lowering drug (oral or injection) can be added or discontinued during the study at the investigators discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (Standard care) | No intervention | –In this arm the patients continue to measure blood glucose with fingerprick and use standard insulin pens |
| 2 (CGM and connected pen) | Active comparator | Device: Continuous glucose monitoring and use of connected insulinpen for bolus insulinIn this arm the patients switch from glucose measurement with fingerprick to continuous glucose monitoring and they switch from standard insulin pen for bolusinsulin to connected pen for bolusinsulin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- - Type 2 DM.
- - HbA1c > 53 mmol/l (7.0 %, estimated average glucose (eAG) 8.6 mmol/l).
- - Contact to diabetes clinic for ≥ 6 months.
- - Insulin treatment ≥ 12 months.
- - Basal insulin and bolus insulin at least for one meal every day.
Key exclusion criteria (10 listed)
- - Individual goal for HbA1c is reached (even if > 53 mmol/mol), i.e. relaxed treatment goals as relevant for fragile patients with severe diabetic complications or comorbidities.
- - Fasting C-peptide < 370 pmol/l.
- - Actual treatment with CGM or previous use of CGM for more than four weeks or < 6 months before recruitment. No actual or previous use of connected pen.
- - One or more severe hypoglycemic episode (assistance of third party) within the previous 12 months.
- - Considered unable to participate due to frequent cancellation of appointments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitoring and use of connected insulinpen for bolus insulinContinuous glucose monitoring (Abbott Freestyle Libre 2) and use of connected insulinpen (Novopen 6) for bolus insulin | Device | 2 (CGM and connected pen) |
Primary outcome
Change in Haemoglobin A1c
Time frame: Baseline and follow-up after 12 months
Change between groups in Haemoglobin A1c (mmol/mol) from baseline to follow-up A prespecified exploratory analysis is planned for: male vs. female age < 65 year vs. age ≥ 65 year baseline HbA1c < 58 mmol/l vs baseline HbA1c ≥58 mmol/l Bolus insulin for 1 or 2 meals at baseline vs. bolus insulin for > 2 meals Number of average views by Libre 2 for the last month < 10 vs. per day vs. ≥10 scannings. A per-protocol analysis will be performed for patients in the intervention arm with available glucose values for more than 70 % of the time during the last 30 days.
9 secondary outcomes
Change Time in range
Time frame: Baseline and follow-up after 12 months
Change in Time above range
Time frame: Baseline and follow-up after 12 months
Change in Time below range
Time frame: Baseline and follow-up after 12 months
Mean glucose
Time frame: Baseline and follow-up after 12 months
Standard deviation
Time frame: Baseline and follow-up after 12 months
Change in CV
Time frame: Baseline and follow-up after 12 months
Change in Time with rapid glucose change
Time frame: Baseline and follow-up after 12 months
Change in ARRC
Time frame: Baseline and follow-up after 12 months
Fraction of patients with increased number of bolus insulin per day
Time frame: Baseline and follow-up after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: Yes. Data planned to make available: All primary and secondary outcome values
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klavs W Hansen study director
Medical Diagnostic Center, Silkeborg Regional Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring and use of connected insulinpen for bolus insulin in people with Type 2 Diabetes Treated With Insulin, run by Klavs Würgler Hansen at 5 sites 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 11 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Haemoglobin A1c (time frame: Baseline and follow-up after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024.