Exploring the use of a digitally delivered low calorie diet and behaviour change programme on inducing diabetes remission in patients with type 2 diabetes.

Not Applicable

• Conditions: Remission in patients with type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN73786674
• Lead Sponsor: Habitual Health Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-04
• Last Update Posted: 8 July 2024
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Able and willing to give consent for the study prior to participation
2. Be aged 18 - 75 years, with type 2 diabetes mellitus of duration <6 years
3. Have access to a smartphone or a computer
4. Have a Body Mass Index (BMI) of at least 28 kg/m²
5. A HbA1c test >48 mmol/mol (6.5%) and =86 mmol/mol (10%), within the previous 12 months

Exclusion Criteria

1. Are currently using insulin
2. Weight change of >5% in the past 3 months
3. Have a history or are known to be suffering with alcohol/substance abuse
4. Have cancer or currently under investigation for cancer
5. Have had a myocardial infarction within the previous 6 months
6. Have severe or unstable heart failure e.g. NYHA grade IV
7. Have porphyria
8. Have learning difficulties
9. Are currently on treatment with anti-obesity drugs
10. Have had bariatric surgery
11. Have been diagnosed with eating disorder or purging
12. Are pregnant or less than 4 months postpartum or considering pregnancy in the next 2 years
13. Are currently breastfeeding
14. Have required hospitalisation for depression or taking antipsychotic drug
15. Have a history of illnesses that could interfere with the interpretation of the study results(e.g. HIV, Cushing syndrome, chronic kidney disease, chronic liver disease, hyperthyroidism, hereditary fructose intolerance, depression or antipsychotic drug use within the past 2 years)
16. Currently taking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs)
17. Have pancreatitis
18. Currently taking part in a CTIMP trial for antidiabetic medication
19. Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Weight (kg) at baseline and 6 months<br>2. HbA1c after at least 2 months off all glucose-lowering medication, measured at 6 months

Secondary Outcome Measures

Name	Time	Method
1. Glycaemic control measured using HbA1c at baseline, 3 and 6 months<br>2. Weight measured at baseline, 3 and 6 months<br>3. Waist circumference measured at baseline, 3 and 6 months<br>4. Systolic blood pressure measured at baseline, 3 and 6 months<br>5. Diastolic blood pressure measured at baseline, 3 and 6 months<br>6. Medication use reported by the participant at baseline, 3 and 6 months<br>7. Evaluation of overall safety of Habitual Remission Programme by the monitoring of the number of i) AEs, ii) SAEs, iii) (S)AEs that constitute Major Adverse Cardiovascular Events and iv) Major Adverse Diabetes Events, for 6 months<br>8. Intervention adherence measured by the number of participants starting the intervention at baseline compared to those completing the intervention at 3 and 6 months