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

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: Completed
• Conditions: Diabetes Mellitus, Type 2; Peer Support; Instant Messaging Service
• Intervention / Treatment: Other: Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool); Other: antidiabetic therapy according to the current guidelines

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	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

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)	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)	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)	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)	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)	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)	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)	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	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)	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	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

• Sponsor: St. Pölten University of Applied Sciences
• Collaborators: Karl Landsteiner University of Health Sciences; Austrian Health Insurance Fund

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Online Intervention; Diabetes Mellitus Type 2; Glycaemic Control; Peer Support; Instant Messaging Service
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Physiological Effects of Drugs; Hypoglycemic Agents
• Other Study ID 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