Digitally-Enabled Weight Management Program on T2DM

Abbott

Status: Completed

Conditions: Type 2 Diabetes; Weight Change, Body

Treatments: Other: Option 1; Other: Option 2; Other: Option 3

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05483140

HA55

Details and patient eligibility

About

The study (known as clinical audit in UK) will observe and report on a digitally-enabled structured weight management program including use of a meal replacement on clinical and economic outcomes for community-dwelling adults living with type 2 diabetes.

Enrollment: 217 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have a clinical diagnosis of T2DM within the last 6 years
2. Aged 20 - 70 years
3. Have a BMI ≥ 27 kg/m2
4. HbA1c ≥ 48 mmol/mol (≥ 42mmol/mol if prescribed glucose-lowering agents)
5. Have access to the internet and a computer, smartphone or tablet
6. Ability to read and understand English
7. Willing to provide individual consent

Exclusion criteria

1. Current insulin use
2. More than two anti-hyperglycemic agents prescribed
3. Recent routine HbA1c ≥ 90 mmol/mol
4. Diagnosed with moderate or severe frailty
5. Diagnosed eating disorder or purging
6. Unable or unwilling to tolerate soy/milk-based meal replacements
7. Myocardial infarction within last 6 months
8. Recent eGFR <30 ml/min/1.73 m2
9. Prescribed SGLT2 inhibitor for diabetic kidney disease (DKD) or left ventricular hypertrophy (LVH)
10. Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA)
11. Current treatment with anti-obesity drugs
12. Learning difficulties that would prevent engagement with the program
13. Having required hospitalization for depression or being prescribed antipsychotic drugs
14. Known cancer
15. Active substance misuse
16. Contraindications to exercise
17. Contraindications to lose weight
18. Mental or physical incapacity that makes self-management inappropriate
19. Pregnant, planning a pregnancy or lactating
20. Currently undergoing palliative care
21. Previous bariatric surgery or on waiting list for bariatric surgery (unless willing to come off waiting list)
22. Unable to commit to long term lifestyle change
23. Known proliferative retinopathy that has not been treated

Trial design

217 participants in 1 patient group

Low Energy Diet Group

Description:

A low energy diet comprising of three options and lifestyle modifications as part of a digitally enabled weight loss program.

Treatment:

Other: Option 3

Other: Option 2

Other: Option 1