Clinical trial NCT05483140: Digitally-Enabled Weight Management Program on T2DM
Official title: Assessing The Effectiveness of A Digitally Enabled Low Energy Diet on Type 2 Diabetes Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Change, Body
Type 2 Diabetes
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Changing Health
name: National Health Service, United Kingdom
First posted: 2022-08-01
Enrollment: 217
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling adults - In partnership with North East and North Cumbria NHS Integrated Care System (ICS) we will engage with the four integrated care providers (ICP) and their Primary Care Networks (PCNs) across this system to identify and receive eligible referrals for participation in this program

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Program Feasibility
timeFrame: Baseline to 12 Months
measure: Program Effectiveness
timeFrame: Baseline to 12 Months
Secondary outcomes:
measure: Glycemic Control
timeFrame: Baseline to 12 Months
measure: Diabetes Distress
timeFrame: Baseline to 12 Months
measure: Medication Usage use
timeFrame: Baseline to 12 Months
Other outcomes:
measure: Healthcare Resource Utilization (HRU), including unplanned (non-study-related) (re)hospitalizations, emergency department (ED) visits, and outpatient clinic visits, depending on data
timeFrame: Baseline to 12 Months
measure: HRU Cost-Savings service, depending on data availability.
timeFrame: Baseline to 12 Months
measure: Quality of Life (QOL) SF-12
timeFrame: Baseline to 12 Months
Locations:
city: Middlesbrough
country: United Kingdom
facility: Nhs Tees Valley Ccg
city: Morpeth
country: United Kingdom
facility: Nhs Northumberland Ccg
city: Newcastle upon Tyne
country: United Kingdom
facility: Nhs Newcastle Gateshead Ccg
city: North Shields
country: United Kingdom
facility: Nhs North Tyneside Ccg
Study officials:
affiliation: Abbott Nutrition
name: Maria Camprubi, PhD
role: STUDY_CHAIR
References: