Digitally-Enabled Weight Management Program on T2DM

Type 2 Diabetes Clinical Trial

Official title:

Assessing The Effectiveness of A Digitally Enabled Low Energy Diet on Type 2 Diabetes Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05483140
• Other study ID #: HA55
• Status: Active, not recruiting
• Start date: October 26, 2022
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 217
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight Changes
• Diabetes Mellitus, Type 2
• Type 2 Diabetes
• Weight Change, Body

Intervention

Other:
• Option 1
Partial meal replacement to achieve 900-1000 kcal/day (4 meal replacement products per day combined with 150-200 kcal from vegetable meals (recipes provided))
• Option 2
Partial meal replacement to achieve 900-1000 kcal/day (2 meal replacement products per day combined with one balanced meal (recipes provided))
• Option 3
A real food low energy diet to achieve 800-1000 kcal/day (recipes provided)

Locations

Country	Name	City	State
United Kingdom	Nhs Tees Valley Ccg	Middlesbrough
United Kingdom	Nhs Northumberland Ccg	Morpeth
United Kingdom	Nhs Newcastle Gateshead Ccg	Newcastle upon Tyne
United Kingdom	Nhs North Tyneside Ccg	North Shields

Sponsors (3)

Lead Sponsor	Collaborator
Abbott Nutrition	Changing Health, National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare Resource Utilization (HRU), including unplanned (non-study-related) (re)hospitalizations, emergency department (ED) visits, and outpatient clinic visits, depending on data	Number of unplanned inpatient hospitalizations, outpatient clinic visits, emergency department visits	Baseline to 12 Months
Other	HRU Cost-Savings service, depending on data availability.	Change in cost of overall healthcare resource utilization	Baseline to 12 Months
Other	Quality of Life (QOL) SF-12	Patient Reported (QOL) questionnaire	Baseline to 12 Months
Primary	Program Feasibility	Participant and HCP completed program questionnaire scored from 0 to 10 where higher score is more favorable	Baseline to 12 Months
Primary	Program Effectiveness	Mean Weight Change	Baseline to 12 Months
Secondary	Glycemic Control	Mean HbA1c change	Baseline to 12 Months
Secondary	Diabetes Distress	Participant completed PAID5 (Problem Areas In Diabetes) diabetes-related emotional distress scale from 0 to 100 where higher rating is less favorable	Baseline to 12 Months
Secondary	Medication Usage use	Medications prescribed from baseline throughout study phases	Baseline to 12 Months