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

NCT04797429 | Completed

• 1 other identifier: LS18-021
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2; Peer Support; Instant Messaging Service

Keywords

Diabetes Mellitus Type 2; Online Intervention; Peer Support; Instant Messaging Service; Glycaemic Control

Outcome Measures

Primary Outcomes (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

  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)

• 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)

  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)

  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)

  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)

  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)

  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

Study Arms (2)

intervention group

EXPERIMENTAL

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)

control group

ACTIVE COMPARATOR

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

Interventions

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

intervention group

antidiabetic therapy according to the current guidelines OTHER

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

control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Pölten University of Applied Sciences: lead
• Karl Landsteiner University of Health Sciences: collaborator
• Austrian Health Insurance Fund: collaborator

Study Sites (1)

Sankt Pölten University of Applied Sciences

Sankt Pölten, Lower Austria, 3100, Austria

Location

Related Publications (1)

• 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.

  PMID: 35422003 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: blinding is not possible because of obvious differences between the interventions: the intervention group participates in the IMS-intervention and the control group does not
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 15, 2021
• Study Start: November 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)