N/A
Completed N=17
Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion
Source: ClinicalTrials.gov NCT04267770 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Basal Insulin Rate — 1.8; 1.49 Units of insulin
Summary
Randomised controlled trial to contribute to the evidence base for the optimal initial insulin profile for adults with type 1 diabetes commencing insulin pump therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Basal Insulin Rate |
1.8; 1.49 | — |
Eligibility Criteria
Inclusion Criteria
- Adults ≥18 years of age
- Diagnosis of T1DM for > 1 year
- On MDI with decision made to commence CSII
- Structured education in previous 3 years
- HbA1c ≤ 75mmol/mol (9%)
- Stimulated c-peptide <200pmol/L
- No severe hypoglycaemia (defined as needing 3rd party assistance) in previous year
Exclusion Criteria
- Previous CSII
- Night or shift worker
- 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 (NCT04267770). 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.