Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06134934
Other study ID # N-20230026
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 9, 2024
Est. completion date March 1, 2025

Study information

Verified date January 2024
Source Aalborg University Hospital
Contact Sisse H Laursen, PhD
Phone +4528189779
Email sih@hst.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This feasibility study will evaluate the feasibility of two telemonitoring designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.


Description:

Background: Maintaining optimal glycaemic control in type 2 diabetes (T2D) is difficult. Telemedicine has potential to support poorly controlled people with T2D in the achievement of glycaemic control if the telemedicine solution includes a telemonitoring component. However, only few telemonitoring solutions for non-insulin treated T2D exist. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring intervention designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial. Method: The trial will be conducted as a three-month randomized feasibility study in four municipalities in North Denmark with 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, differences in direct intervention costs between the two alternative interventions will be evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women and men = 18 years - Poorly controlled T2D, i.e. HbA1c > 58 mmol/mol - Diagnosis of T2D for at least 12 months - General Practitioner responsible for diabetes treatment - Residence in Hjørring, Morsø, Jammerbugt, or Rebild municipality - Ability and willingness to use a smartphone/tablet along with the other devices to be used in the trial - Signed informed consent - Ability to understand and read Danish Exclusion Criteria: - Pregnancy or breastfeeding - Insulin treatment - Prednisolone treatment - Severe diabetes complications such as severe neuropathy or nephropathy (dialysis treatment) - Participation in diabetes rehabilitation courses - Participation in other intervention trials - Terms that, in the opinion of the sub-investigator or investigator, render the participant unfit to conduct the trial, including lack of understanding of the trial or lack of physical or cognitive ability to participate

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Telemonitoring 1
This telemonitoring intervention design include self-monitoring of blood glucose (SMBG) together with monitoring of sleep, mental health, blood pressure and activity.
Telemonitoring 2
This telemonitoring intervention design include self-monitoring of blood glucose (SMBG) together with monitoring of sleep and mental health.

Locations

Country Name City State
Denmark Steno Diabetes Center North Denmark Aalborg

Sponsors (3)

Lead Sponsor Collaborator
Aalborg University Hospital Aalborg University, Steno Diabetes Center Nordjylland

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Experiences with and acceptability of intervention design(s) Qualitative interviews will be conducted with selected participants and HCPs to gain deeper insight into the participants and HCPs' experiences and acceptability with the two different telemonitoring intervention designs and the trial procedures. 3 months
Secondary Feasibility of the recruitment assessment 1 Number (whole) of people agreeing to receive participant information letter about the study. 1 month
Secondary Feasibility of the recruitment assessment 2 Proportion (percentage) of people agreeing to receive participant information letter about the study. 1 month
Secondary Feasibility of the recruitment assessment 3 Number (whole) of eligible participants who agree to participate. 1 month
Secondary Feasibility of the recruitment assessment 4 Proportion (percentage) of eligible participants who agree to participate. 1 month
Secondary Feasibility of the recruitment assessment 5 Potential inequalities regarding recruitment feasibility assessed by comparing those who accepted participation to those who declined with respect to demographic data on age (years), sex (m/f/other), ethnicity (danish/other western/not western), municipality, setting (health care center versus home health care setting), and HbA1c levels (mmol/L). 1 month
Secondary Retention assessment 1 Number (whole) of participants withdrawing from the trial. 3 months
Secondary Retention assessment 2 Proportion (percentage) of participants withdrawing from the trial. 3 months
Secondary Retention assessment 3 Timepoint(s) for withdrawal. 3 months
Secondary Retention assessment 4 Reasons of discontinuation of the trial. 3 months
Secondary Retention assessment 5 Potential inequalities regarding retention feasibility assessed by comparing those who retented participation to those who withdrawal with respect to demographic data on age (years), sex (m/f/other), ethnicity (danish/other western/not western), municipality, setting (health care center versus home health care setting), and HbA1c levels (mmol/L). 3 months
Secondary Adherence to answering the questionnaire: Diabetes-related quality of life: The Problem Areas in Diabetes Questionnaire (PAID-5) The respons rate for PAID-5 at baseline and at 3 months, respectively. At baseline (T0) and 3 months (T1)
Secondary Adherence to answering the questionnaire: Quality of Life: The Short Form 12 Questionnaire (SF-12v2) The respons rate for SF-12v2 at baseline and at 3 months, respectively. At baseline (T0) and 3 months (T1)
Secondary Adherence to answering the questionnaire: Well-being: The World Health Organization Five Well-being Index (WHO-5) The respons rate for WHO-5 at baseline and at 3 months, respectively. At baseline (T0) and 3 months (T1)
Secondary Adherence to answering the questionnaire: The Patient Activation Measure questionnaire (PAM) The respons rate for PAM at baseline and at 3 months, respectively. At baseline (T0) and 3 months (T1)
Secondary Challenges in the blood sampling schedule Explore through qualitative interviews whether there are any analysis challenges or uncertainties in the clinical workflow with regard to the blood sampling schedule. At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3)
Secondary Adherence to the blood sampling schedule Number and proportion of the participants who completes the blood sampling at baseline, 3 months, 6 months, and 12 months, respectively. At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3)
Secondary Costs Differences in direct intervention costs between the two alternatives. Resource categories are comprised of equipment and time spent on monitoring, time spent training patients in using the equipment, and potential additional training for community nurses. Resources will be evaluated as prices paid and hourly wages and represented as equivalent annual costs in 2023 prices. 12 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2