NCT05483140Completed
Digitally-Enabled Weight Management Program on T2DM
Assessing The Effectiveness of A Digitally Enabled Low Energy Diet on Type 2 Diabetes Management
Source: ClinicalTrials.gov · Last updated 12 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 217 (actual)
- First submitted
- 29 Jul 2022
- Start date
- 30 Sept 2022
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Abbott Nutrition
- Diseases
- Type 2 diabetes
- NCT number
- NCT05483140
What you commit to
- Study type: Observational
- Participants enrolled: 217
- From 30 Sept 2022 to the primary completion date, 30 Sept 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with anti-obesity drugs
- Having required hospitalization for depression or being prescribed antipsychotic drugs
- Previous bariatric surgery or on waiting list for bariatric surgery (unless willing to come off waiting list)
Other illness
- Diagnosed eating disorder or purging
- Myocardial infarction within last 6 months
- Prescribed SGLT2 inhibitor for diabetic kidney disease (DKD) or left ventricular hypertrophy (LVH)
- Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA)
- Known cancer
Lab values
- Recent routine HbA1c ≥ 90 mmol/mol
- Recent eGFR \<30 ml/min/1.73 m2
Other
- Current insulin use
- More than two anti-hyperglycemic agents prescribed
- Diagnosed with moderate or severe frailty
- Unable or unwilling to tolerate soy/milk-based meal replacements
- Learning difficulties that would prevent engagement with the program
- Active substance misuse
- Contraindications to exercise
- Contraindications to lose weight
- Mental or physical incapacity that makes self-management inappropriate
- Pregnant, planning a pregnancy or lactating
- Currently undergoing palliative care
- Unable to commit to long term lifestyle change
- Known proliferative retinopathy that has not been treated
Who the study is looking for
- Have a clinical diagnosis of T2DM within the last 6 years
- Aged 20 - 70 years
- Have a BMI ≥ 27 kg/m2
- HbA1c ≥ 48 mmol/mol (≥ 42mmol/mol if prescribed glucose-lowering agents)
- Have access to the internet and a computer, smartphone or tablet
- Ability to read and understand English
- Willing to provide individual consent
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nhs Tees Valley Ccg Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| Nhs Northumberland Ccg Coordinator of this site? Confirm its status | Morpeth | United Kingdom | Unknown status |
| Nhs Newcastle Gateshead Ccg Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Nhs North Tyneside Ccg Coordinator of this site? Confirm its status | North Shields | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.