Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion
FIRST1D
A Study of Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion (CSII) in Adults With Type 1 Diabetes
1 other identifier
interventional
17
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2018
CompletedFirst Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedResults Posted
Study results publicly available
March 31, 2020
CompletedMarch 31, 2020
March 1, 2020
7 months
February 11, 2020
March 3, 2020
March 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Basal Insulin Rate
Absolute change in insulin basal rate over 24 hours after 3 rounds of basal rate testing (calculated by the sum of absolute changes for each 1 hour block compared with baseline)
over 24 hours after 3 rounds of basal rate testing
Study Arms (2)
circadian insulin infusion rates
EXPERIMENTALInitial variable basal rates aim to replicate circadian changes in insulin requirements and are derived from total basal insulin in adults over 24 years old, and from weight in adults aged 18 to 24 years.
flat rates
ACTIVE COMPARATORflat basal rate
Interventions
Participant's own insulin adjusted to circadian infusion rates
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College Clinical Research Facility
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nick Oliver
- Organization
- Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 13, 2020
Study Start
April 10, 2018
Primary Completion
November 9, 2018
Study Completion
November 9, 2018
Last Updated
March 31, 2020
Results First Posted
March 31, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share