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

NCT ID: NCT04797429

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2025-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

antidiabetic therapy according to the current guidelines

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karl Landsteiner University of Health Sciences

OTHER

Sponsor Role: collaborator

Austrian Health Insurance Fund

UNKNOWN

Sponsor Role: collaborator

St. Pölten University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sankt Pölten University of Applied Sciences

Sankt Pölten, Lower Austria, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 35422003 (View on PubMed)

Other Identifiers

LS18-021

Identifier Type: -

Identifier Source: org_study_id