AzTrials
AzTrials

Diabetes Mellitus, Type 2DiabPeerSNCT04797429

Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging

A study testing Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool) and antidiabetic therapy according to the current guidelines in people with Diabetes Mellitus, Type 2 and Peer Support, run by St. Pölten University of Applied Sciences at 1 site in Austria.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool) and antidiabetic therapy according to the current guidelines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteAustria
Study dates
1 Nov 2020to 1 Mar 2025
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • hospitalization of more than 3 weeks during the intervention
  • 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
  • substance abuse
  • pregnancy
  • limitation in the German language
  • unable to visit training and measurements

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Sankt Pölten University of Applied Sciences

    Sankt Pölten, Lower Austria, 3100

Other trials in Austria

About this study

Official title: Improving Glycaemic Control in Patients With Type 2 Diabetes Mellitus Through Peer Support Instant Messaging: a Randomized Controlled Trial

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.

Being tested
Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool), antidiabetic therapy according to the current guidelines
Keywords
Diabetes Mellitus Type 2, Online Intervention, Peer Support, Instant Messaging Service, Glycaemic Control
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.

  • Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool)Other

    Peer Support via the IMS-tool increases diabetes self-management, improves self-efficiacy, adherence and glycaemic control

  • antidiabetic therapy according to the current guidelinesOther

    In contrast, the control group has to manage their diabetes mellitus type 2 with standard support and without online exchange.

Study groups in NCT04797429
Study groupRoleWhat they receive
intervention groupExperimentalThe intervention group will receive antidiabetic therapy according to the current guidelines but with the additional opportunity to use the peer support IMS tool. Peer support and moderation of the intervention group will be provided by moderators. Moderators will be supervised by a dietitian.
Receives: Other: Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool)
control groupActive comparatorThe control group receives the antidiabetic therapy according to the current guidelines, but without having access to the IMS tool. This means that participants receive medical treatment by their practitioner according to the Austrian recommendations.
Receives: Other: antidiabetic therapy according to the current guidelines

What is being measured

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

  1. HbA1c [%] (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates)

    HbA1c = glycated haemoglobin reflects average plasma glucose over the previous 8-12 weeks. It can be tested at any time of the day and does not require special preparation like fasting

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

Secondary outcomes (10)
  1. Quality of life measured by Short-Form-Health Survey (SF-12) (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates)

    Quality of life will be measured using the 'Short-Form-Health Survey' (SF-12): the SF-12 includes eight dimensions ('physical functioning', 'role limitations due to physical problems', 'bodily pain', 'vitality', 'general health perceptions' , 'social functioning', 'role limitations due to emotional problems', 'mental health'). The summary scores 'physical component summary' and 'mental component summary' (0-100 scales) can be calculated from the specified scales.

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  2. Medication adherence measured by A-14 (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates)

    Medication adherence will be measured using the 'A14-scale': the A14 consists of 14 items of non-adherent behaviors phrased in a non-threatening and non-judgemental way using a five-item Likert scale with the endpoints '4' (never) to '0' (very often).

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  3. Diabetes self-management behaviors measured by 'Summary of Diabetes Self-Care Activities German' (SDSCA-G) (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates)

    Diabetes self-management behaviors will be measured using the 'Summary of Diabetes Self-Care Activities German' (SDSCA-G): the SDSCA-G focuses on the past seven days related to the diabetes self-care activities 'nutrition', 'physical activities', 'blood glucose testing', 'foot care', and 'smoking'.

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  4. Diabetes knowledge will be measured using the 'Diabetes Knowledge Test' (DKT)

    DKT consists of 20 statements about diabetes which have to be rated as 'true', 'false' or 'don't know'. Based on the answers, a difficulty index (percent of patients who scored correctly) is calculated.

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  5. Diabetes distress will be measure using the 'Diabetes Distress Scale' (DDS)

    the DDS includes for dimensions of distress ('emotional burden', 'regimen distress', 'interpersonal distress', 'physician distress'). The DDS consists of 17 items using a six-point Likert scale with the endpoints '1' (not a problem) and '5' (a very serious problem).

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  6. Depression will be measured using the 'Patient Health Questionnaire-9' (PHQ-9)

    PHQ-9 asks for all nine criteria of depression as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) using a four-point Likert scale with the endpoints '0' (not at all) and '3' (nearly every day).

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  7. Social support will be measured using the 'Fragebogen zur Sozialen Unterstützung' (F-SozU)

    F-SozU operationalizes social support as perceived or anticipated support from the social environment. The short form consists of the following subscales: 'emotional support', 'practical support', 'social integration', 'stress from the social network'. The F-SozU involves of 14 items using a five-point Likert scale with the endpoints '1' (does not apply) and '5' (accurate).

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  8. Dietary behaviour will be measured using a Food Frequency Questionnaire

    Asses the dietary behaviour during the last month

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  9. Physical activity will be measured using the 'International Physical Activity Questionnaire Short Form' (IPAQ-SF)

    IPAQ-SF asks seven questions to assess 'vigorous-intensity' and 'moderate-intensity' physical activity as well as 'walking' and 'sitting'. Participants indicate the time in minutes or hours for each activity level. Based on this information, three levels of physical activity (low, moderate, high) are calculated and expressed in metabolic equivalent of task (MET) minutes per week.

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

  10. Biochemical parameters

    fasting blood glucose [mg/dl], total cholesterol [mg/dl], high-density lipoprotein [mg/dl], low-density lipoprotein [mg/dl], blood pressurge [mmHg], body height [cm], body weight [cm], body fat [%]

    Measured: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention

Timeline

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

  1. First posted15 Mar 2021
  2. Study start1 Nov 2020
  3. Primary completion1 Jun 2024
  4. Study completion1 Mar 2025

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04797429
Sponsor's protocol ID
LS18-021
Acronym
DiabPeerS
Status last verified
May 2025
First submitted
9 Mar 2021
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hold E, Grublbauer J, Wiesholzer M, Wewerka-Kreimel D, Stieger S, Kuschei W, Kisser P, Gutzer E, Hemetek U, Ebner-Zarl A, Pripfl J. Improving glycemic control in patients with type 2 diabetes mellitus through a peer support instant messaging service intervention (DiabPeerS): study protocol for a randomized controlled trial. Trials. 2022 Apr 14;23(1):308. doi: 10.1186/s13063-022-06202-2.

    PubMed 35422003

Questions about this trial

What is this clinical trial studying?

A study testing Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool) and antidiabetic therapy according to the current guidelines in people with Diabetes Mellitus, Type 2 and Peer Support, run by St. Pölten University of Applied Sciences at 1 site in Austria.

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 18 inclusion and 7 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 21 May 2025. 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 Austria. 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?

HbA1c [%] (change over a period of 7 months intervention and 7 months follow-up with 4 measurement dates) (time frame: at baseline, three months after the start of the intervention, at the end of the intervention = seven months after the start of the intervention, follow-up = 14 months after the start of the intervention). 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 NCT04797429, 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 21 May 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in