TeleCare North Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: Telemonitoring 1Other: Telemonitoring 2
- Registration Number
- NCT06134934
- Lead Sponsor
- Aalborg University Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemonitoring design 1 Telemonitoring 1 * Self-Monitoring of Blood Glucose (SMBG) * Sleep * Mental health * Blood pressure * Activity Telemonitoring design 2 Telemonitoring 2 * Self-Monitoring of Blood Glucose (SMBG) * Sleep * Mental health
- Primary Outcome Measures
Name Time Method Experiences with and acceptability of intervention design(s) 3 months 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.
- Secondary Outcome Measures
Name Time Method Retention assessment 1 3 months Number (whole) of participants withdrawing from the trial.
Adherence to answering the questionnaire: Well-being: The World Health Organization Five Well-being Index (WHO-5) At baseline (T0) and 3 months (T1) The respons rate for WHO-5 at baseline and at 3 months, respectively.
Feasibility of the recruitment assessment 1 1 month Number (whole) of people agreeing to receive participant information letter about the study.
Retention assessment 4 3 months Reasons of discontinuation of the trial.
Challenges in the blood sampling schedule At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3) Explore through qualitative interviews whether there are any analysis challenges or uncertainties in the clinical workflow with regard to the blood sampling schedule.
Costs 12 months 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.
Feasibility of the recruitment assessment 2 1 month Proportion (percentage) of people agreeing to receive participant information letter about the study.
Feasibility of the recruitment assessment 3 1 month Number (whole) of eligible participants who agree to participate.
Feasibility of the recruitment assessment 5 1 month 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).
Adherence to the blood sampling schedule At baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3) Number and proportion of the participants who completes the blood sampling at baseline, 3 months, 6 months, and 12 months, respectively.
Feasibility of the recruitment assessment 4 1 month Proportion (percentage) of eligible participants who agree to participate.
Retention assessment 2 3 months Proportion (percentage) of participants withdrawing from the trial.
Retention assessment 3 3 months Timepoint(s) for withdrawal.
Retention assessment 5 3 months 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).
Adherence to answering the questionnaire: The Patient Activation Measure questionnaire (PAM) At baseline (T0) and 3 months (T1) The respons rate for PAM at baseline and at 3 months, respectively.
Adherence to answering the questionnaire: Diabetes-related quality of life: The Problem Areas in Diabetes Questionnaire (PAID-5) At baseline (T0) and 3 months (T1) The respons rate for PAID-5 at baseline and at 3 months, respectively.
Adherence to answering the questionnaire: Quality of Life: The Short Form 12 Questionnaire (SF-12v2) At baseline (T0) and 3 months (T1) The respons rate for SF-12v2 at baseline and at 3 months, respectively.
Trial Locations
- Locations (1)
Steno Diabetes Center North Denmark
🇩🇰Aalborg, Denmark