Manchester Intermittent and Daily Diet Type 1 Diabetes App Study (MIDDAS-Type 1)

NCT04674384 | Unknown

• 1 other identifier: B01030
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety, acceptability and feasibility of testing Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) programmes for 12 weeks in a real life setting with people with T1D and obesity.

Conditions

Type 1 Diabetes; Obesity

Outcome Measures

Primary Outcomes (4)

• Number of episodes of severe hypoglycaemia i.e. capillary blood glucose < 3.0 mmol/l or requiring 3rd party assistance or any episodes of nocturnal hypoglycaemia <3.0 mmol/l.

  14 week duration of study

• Time spent in target (3.9-10mmol/l), below target (<3.9mmol/l and <3.0mmol/l) and above target (>10 mmol/l) on the Freestyle Libre® flash glucose monitoring system over 12 weeks.

  14 week duration of study

• Number of episodes of Diabetic Ketoacidosis (DKA) and blood ketone β-hydroxybutyrate levels above 1.0mmol/l.

  14 week duration of study

• Occurrence of Serious Adverse Events (SAEs) deemed potentially related to the dietary programmes.

  14 week duration of study

Secondary Outcomes (12)

• Uptake to the trial i.e. percentage of those invited who are eligible and interested to take part

  14 week duration of study

• Number of participants who complete the trial measured by attendance at the 12 week appointment (for ILED and CLED)

  14 week duration of study

• Adherence to blood glucose and ketone monitoring i.e. frequency of capillary blood tests and scans

  14 week duration of study

• Percentage of low energy days completed (for ILED and CLED)

  14 week duration of study

• Dietary intake (7 day food diary). Food diaries will be analysed using Nutritics nutrition analysis software to estimate energy, fat, saturated fat, carbohydrate and protein intake

  14 week duration of study

Study Arms (2)

Intermittent Low Energy Diet (ILED)

ACTIVE COMPARATOR

Dietary Supplement: Optifast meal replacement shakes

Continuous Low Energy Diet (CLED)

ACTIVE COMPARATOR

Dietary Supplement: Optifast meal replacement shakes

Interventions

Optifast meal replacement shakes DIETARY_SUPPLEMENT

Optifast® is provided as 53g sachet. Each sachet replaces one meal. It is available in 5 flavours: vanilla, strawberry, chocolate and coffee shakes and vegetable soup.

Continuous Low Energy Diet (CLED); Intermittent Low Energy Diet (ILED)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T1D for 12 months or longer
• HbA1c 53-108 mmol/mol
• BMI ≥ 30 kg/m2 and \<50kg/ m2 or ≥27.5 kg/ m2 and \<50kg/ m2 in high-risk minority ethnic groups i.e. South Asian, Black African and African Caribbean
• Multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
• Completed Dose Adjustment For Normal Eating (DAFNE) education
• Access to a Freestyle Libre handset and sensors to monitor blood glucose
• Willing to use the Freestyle Libre® flash glucose monitoring system to monitor blood glucose (flash and capillary) and blood ketones and to record carbohydrate and insulin.
• Access to and ability to use a telephone. If no access to a smartphone running iOS or Android (to view the LibreLink app®) then access to a computer (to upload results to the LibreView website).
• Willing to undertake Optifast® LEDs and have previously sampled Optifast®.
• Negative urine pregnancy test at screening and agreement to maintain contraception or abstinence for the trial (where appropriate)
• Ability to read, understand and communicate in English.

You may not qualify if:

• Evidence of severe hypoglycaemia in the last 12 months (more than one episode requiring third party assistance) or hypoglycaemia unawareness.
• Patients with non-stable retinopathy, or grade R2 or later, or had no retinopathy screen within 12 months.
• Patients who lack capacity or are unable to read or understand written or verbal instructions in English or those diagnosed with learning difficulties.
• Confirmed pregnant via a pregnancy test at screening, planning pregnancy in the next 3 months, or currently breast feeding.
• Participants who are currently on treatment with Orlistat or other pharmacological treatments for weight loss e.g. Glucagon-like-peptide-1 (GLP-1).
• Participants who are currently taking a Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor.
• Diagnosed Gastroparesis.
• Participants who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy.
• Patients who are on chronic use of steroids (more than 20mg daily of prednisolone or its equivalent).
• Patients with known hypersensitivity to any of the ingredients of Optifast® e.g. fish, milk, soy.
• Taking prohibited medications (see Appendix 3) including warfarin or novel anticoagulants (NOAC), low molecular weight heparin (LMWH) or equivalent anti-coagulants and anti-psychotic medication or other psychotropic medications that may cause excessive weight gain.
• Substance abuse or harmful alcohol use as indicated by a score of 16 or above on the Alcohol Use Disorders Identification Test (AUDIT).\[36\]
• Participants with a diagnosed eating disorder, or patients with severe binge eating assessed by a score of 27 or more on the Binge Eating Scale (BES).\[37\]
• Participants with severe depression assessed by a score of 15 or more on the Patient Health Questionnaire-9 (PHQ-9) questionnaire.\[29\]
• Participants with severe anxiety assessed by a score of 15 or more on the General Anxiety Disorder (GAD-7) questionnaire.\[28\]

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M23 9QZ, United Kingdom

RECRUITING

Related Publications (1)

• McDiarmid S, Harvie M, Aglan A, Winterbottom H, Mubita W, Hulme A, Davies J, Yates J, Krizak S, Perry D, Issa BG. Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1): protocol for a randomised feasibility trial of an intermittent and continuous low-energy diet in patients with type 1 diabetes and overweight and obesity. BMJ Open. 2023 Jul 20;13(7):e071395. doi: 10.1136/bmjopen-2022-071395.

  PMID: 37474169 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 19, 2020
• Study Start: January 19, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)