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

May 15, 2025 updated by: St. Pölten University of Applied Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Lower Austria
      • St. Pölten, Lower Austria, Austria, 3100
        • Sankt Pölten University of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria participants exclusive moderators:

  • 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

Inclusion criteria moderators:

  • 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

Exclusion Criteria for all participants:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention group
The 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.
Other: Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool)
Peer Support via the IMS-tool increases diabetes self-management, improves self-efficiacy, adherence and glycaemic control
Active Comparator: control group
The 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.
Other: antidiabetic therapy according to the current guidelines
In contrast, the control group has to manage their diabetes mellitus type 2 with standard support and without online exchange.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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.
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
Medication adherence measured by A-14 (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
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).
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
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)
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
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'.
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
Diabetes knowledge will be measured using the 'Diabetes Knowledge Test' (DKT)
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
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.
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
Diabetes distress will be measure using the 'Diabetes Distress Scale' (DDS)
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
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).
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
Depression will be measured using the 'Patient Health Questionnaire-9' (PHQ-9)
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
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).
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
Social support will be measured using the 'Fragebogen zur Sozialen Unterstützung' (F-SozU)
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
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).
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
Dietary behaviour will be measured using a Food Frequency Questionnaire
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
Asses the dietary behaviour during the last month
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
Physical activity will be measured using the 'International Physical Activity Questionnaire Short Form' (IPAQ-SF)
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
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.
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
Biochemical parameters
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
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 [%]
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Pölten University of Applied Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karl Landsteiner University of Health Sciences
Austrian Health Insurance Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LS18-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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