Type 2 Diabetes (T2D) Clinical Trials

Find Type 2 Diabetes (T2D) Clinical Trials Near You

Outcomes-Based Health Program for Improving Care and Outcomes in Patients With Type 2 Diabetes: A Real-World Implementation Study in Primary Care

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Type 2 diabetes is a growing health concern worldwide, influenced by genetic factors, overweight, metabolic syndrome, and insufficient physical activity. Good treatment and glycemic control can reduce or delay diabetes-related complications, which account for a significant and increasing share of healthcare costs in Finland. Much of this cost growth is due to complications resulting from inadequate diabetes care. Secondary prevention programs can therefore provide both health and economic benefits. Lifestyle interventions are one way to improve type 2 diabetes care and reduce complications. This study aims to evaluate the impact of a digital lifestyle intervention combined with optimized care on treatment and outcomes among adults with type 2 diabetes at high risk for complications. The intervention includes access to the BitHabit Small Actions application, which supports healthy lifestyle changes, and for participants with a body mass index (BMI) over 30, the Onnikka weight management application. The study will be conducted in North Savo, Finland, using a case-control design. Approximately 120 participants will receive the intervention and 50-100 will serve as controls. All participants will have their care plans reviewed and updated according to the Finnish Current Care Guidelines for Type 2 Diabetes. Control group participants will receive standard care, while the intervention group will receive standard care plus the digital tools. The study also includes the validation of the PAID (Problem Areas in Diabetes) questionnaire for use in Finland and in the Finnish language. The study duration for each participant is 12 months. Data will be collected through physiological measurements, laboratory tests, questionnaires, and app usage logs. Measurements and questionnaires will be conducted at baseline and after 12 months. The analyses will describe the phenomenon, its prevalence, and associations between variables, as well as potential dependencies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 74
Healthy Volunteers: f
View:

• Type 2 diabetes diagnosed

• At least one of the following:

‣ diagnosed coronary artery disease,

⁃ diagnosed periferal artery disease,

⁃ diagnosed heart failure,

⁃ diagnosed diabetic renal disease (GFR \<60 OR uACR ≥ 3 for at least three months),

⁃ diagnosed diabetic retinopathy,

⁃ previous stroke,

⁃ diagnosed atrial fibrillation or atrial flutter,

⁃ age ≥ 55 years and at least two of the following conditions:

• smoker

∙ uses antihypertensive medication or systolic blood pressure \>140 mmHg or diastolic blood pressure \> 80 mmHg,

∙ uses lipid lowering medication or LDL-cholesterol \> 2.6 or

∙ BMI \> 25

Locations
Other Locations
Finland
Wellbeing services county of North Savo, Nursing and Physician Services
RECRUITING
Kuopio
Contact Information
Primary
Elina Pimiä, MD
elina.pimia@diabetes.fi
+358503222755
Backup
Sonja Soininen, MD, PhD
sonja.soininen@pshyvinvointialue.fi
+358444611199
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 200
Treatments
Experimental: Digital intervention arm
Digital interventions: BitHabit application and optionally Onnikka application
No_intervention: Control group
Control group receives same enhancement in treatment plan, but no digital interventions
Sponsors
Collaborators: Finnish Diabetes Association, University of Eastern Finland
Leads: Kuopio University Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials