NCT04797429Completed
Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging
Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 May 2025
Brief summary (registry, in English)
Diabetes mellitus is one of the four priority non-communicable diseases worldwide. Globally, 425 million adults suffered from diabetes mellitus (7.2-11.3%) in 2017 and the International Diabetes Federation estimates an increase of 48% of the prevalence until 2045. Type 2 diabetes, which is the most common type of diabetes, is mainly seen in adults older than 40 years. Diabetes can lead to serious long-term complications as well as a lower quality of life, worse mental health, and a reduced life expectancy. Due to the chronical character of diabetes, the disease requires continuous therapy, regular medical appointments, and good adherence of those suffering. Therefore, diabetes self-management education (DSME) plays a significant role to increase patient's self-management capacity and improve diabetes therapy. Research indicates that these outcomes might be difficult to maintain and seem to decline soon after DSME ends. Consequently, effective strategies to preserve the positive effects of DSME are needed. Preliminary results show that peer support, which means support from a person who has experiential knowledge of a specific behaviour or stressor and similar characteristics as the target population, is associated with better outcomes in terms of HbA1c, cardiovascular disease risk factors or self-efficacy at lower cost compared to standard therapy. Although those results are promising, research on peer support in diabetes care is still in its infancy and the influence of various factors is unclear. Peer support instant messaging services (IMS) approaches have significant potential for diabetes management because support can be provided easily and prompt, is inexpensive, and needs less effort to attend compared to standard therapy. Furthermore, almost half of the 40-69-year-old age group, which is mostly affected by the onset of type 2 diabetes, use IMS. The major objective of the project is to analyse the impact of a peer supported IMS intervention in addition to a standard diabetes therapy on the glycaemic control of type 2 diabetic patients. A total of 205 participants (196 participants and 9 moderators) with type 2 diabetes mellitus, older than 40 years will be included and randomly assigned to the intervention or control group. Both groups will receive standard therapy, but the intervention group will use the peer support IMS tool, additionally. The duration of the intervention will last for seven months, followed by a follow-up of seven months. Biochemical, behavioural, and psychosocial parameters will be measured before, in the middle, and after the intervention as well as after the follow-up.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 9 Mar 2021
- Start date
- 1 Nov 2020
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- St. Pölten University of Applied Sciences
- Diseases
- Type 2 diabetes
- NCT number
- NCT04797429
What you commit to
- Study type: Interventional
- Participants enrolled: 68
- From 1 Nov 2020 to the primary completion date, 1 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- eye disorders that severely limit vision and, hence, inability to read the display (e.g., proliferative retinopathy or macular edema)
- severe illnesses such as kidney, liver, heart disease, or malignant cancer, neurological of mental illness which make a longer hospitalization likely
Other
- hospitalization of more than 3 weeks during the intervention
- substance abuse
- pregnancy
- limitation in the German language
- unable to visit training and measurements
Who the study is looking for
- diagnosed type 2 diabetes mellitus according to the Austrian definition
- HbA1c of ≥ 6.5% (48 mmol/mol) at the last measurement
- receive the antidiabetic therapy according to the current guidelines
- older than 40 years
- living in Lower Austria
- get oral hyperglycaemic agents for maximum three years
- understand the individual commitments during trial
- must be able to visit training and measurements
- diagnosed type 2 diabetes mellitus according to the Austrian definition
- HbA1c of ≥ 6.5% (48 mmol/mol) at the last measurement
- receive the antidiabetic therapy according to the current guidelines
- get oral hyperglycaemic agents for three years minimum
- older than 60 years
- living in the vicinity of the training location in St. Pölten, which means residing in St. Pölten, St. Pölten Land, Melk, Krems, or Lilienfeld
- engaged participating (= regular participation) in the Austrian disease management program 'Therapie aktiv - Diabetes im Griff'
- understand the individual commitments during trial
- must be able to visit training and measurements
- commitment to undergo the moderator training
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sankt Pölten University of Applied Sciences Coordinator of this site? Confirm its status | Sankt Pölten | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.