Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Advanced Bolus Calculator
Brief 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)
Detailed description
The Diabetes Technology team at Imperial College have developed a novel advanced bolus calculator. The complete integrated system consists of a commercially available smartphone that holds the novel advanced algorithm. The system requires regular updates of cases derived from retrospective blinded continuous glucose monitoring data and for this a commercially available glucose sensor will be used. Each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (blood glucose following a meal). The novel decision support algorithm is based on case-based reasoning (CBR). CBR is an artificial intelligence technique that tries to solve newly encountered problems by applying the solutions learned from solved problems encountered in the past. The end-product is therefore a subject specific insulin bolus calculator that continues to improve with time. The project utilises commercially available glucose sensors and smartphones (iPhone), integrated with a novel algorithm for insulin bolus calculation. The aim of the ABC4D is to minimise high and low glucose excursions which are associated with the complications of diabetes including blindness, kidney failure, nerve damage and cardiovascular disease. An interim analysis was conducted in Phase 4 after 25 participants completed the study (in line with the protocol) and it was agreed to stop the study at this stage. A further protocol amendment was approved by REC/MHRA to commence ABC4D phase 5 (different CT.gov number: NCT03963219).
Interventions
DEVICEABC4D
Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) to calculate pre-meal insulin boluses
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline to 6 months | Change in HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Time in Target Range | Baseline and 6 months | Difference between baseline and 6-month endpoint. |
| Percentage Time in Hypoglycaemia | Baseline and 6 months | Difference from baseline to 6-month endpoint. |
Countries
United Kingdom
Participant flow
Recruitment details
From diabetes clinics
Participants by arm
| Arm | Count |
|---|---|
| Phase 4: Intervention (ABC4D) & RT - CGM Intervention (ABC4D) & Real-time continuous glucose monitoring over 6 months | 13 |
| Phase 4 Control: Standard Bolus Calculator & RT-CGM Control: standard bolus calculator & Real-time continuous glucose monitoring over 6 months | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Phase 4 Control: Standard Bolus Calculator & RT-CGM | Total | Phase 4: Intervention (ABC4D) & RT - CGM |
|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 14.1 | 38 years STANDARD_DEVIATION 12 | 39.6 years STANDARD_DEVIATION 9.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 12 participants | 25 participants | 13 participants |
| Sex: Female, Male Female | 9 Participants | 15 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 10 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
HbA1c
Change in HbA1c
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention (ABC4D) & RT - CGM | HbA1c | -5.0 mmol/mol |
| Control: Standard Bolus Calculator & RT-CGM | HbA1c | -3.0 mmol/mol |
p-value: 0.87Wilcoxon (Mann-Whitney)
Secondary
Percentage Time in Hypoglycaemia
Difference from baseline to 6-month endpoint.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention (ABC4D) & RT - CGM | Percentage Time in Hypoglycaemia | 0.5 percentage |
| Control: Standard Bolus Calculator & RT-CGM | Percentage Time in Hypoglycaemia | -0.2 percentage |
Secondary
Percentage Time in Target Range
Difference between baseline and 6-month endpoint.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention (ABC4D) & RT - CGM | Percentage Time in Target Range | 0.9 Percentage |
| Control: Standard Bolus Calculator & RT-CGM | Percentage Time in Target Range | 0.0 Percentage |