Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the safety and efficacy of a novel advanced bolus calculator in subjects with Type 1 diabetes. Insulin bolus calculators have been developed to aid insulin dose adjustment and existing standard insulin bolus calculator consist of a simple algorithm that requires five subject-specific parameters as input to generate a recommended bolus insulin dose:

• current blood glucose (mmol/L)

• target blood glucose (mmol/L)

• insulin-to-carbohydrate ratio (grams of carbohydrate per 1 unit of insulin)

• total grams of carbohydrate in meals

• insulin sensitivity factor (reduction in glucose per 1 unit of insulin)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Insulin; Insulin Aspart; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Adults ≥18 years of age

• Diagnosis of T1DM for > 1 year

• On MDI using a basal-bolus insulin regime

• Structured education in previous 3 years

• HbA1c ≤ 86mmol/mol

• No severe hypoglycaemia (defined as needing 3rd party assistance) in previous year

Exclusion Criteria:

• Recurrent severe hypoglycaemia

• Pregnant or planning pregnancy

• Breastfeeding

• Enrolled in other clinical trials

• Have active malignancy or under investigation for malignancy

• Addison's Disease

• Gastroparesis

• Autonomic neuropathy

• Concomitant use of GLP-1 analogues and gliptins

• Visual impairment

• Reduced manual dexterity