N/A
Completed N=25
Advanced Bolus Calculator for Type 1 Diabetes (ABC4D)
Source: ClinicalTrials.gov NCT02053051 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: HbA1c — -5.0; -3.0 mmol/mol — p=0.87
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c |
-5.0; -3.0 | 0.87 |
| SECONDARY Percentage Time in Target Range |
0.9; 0.0 | — |
| SECONDARY Percentage Time in Hypoglycaemia |
0.5; -0.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02053051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.