Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion (FIRST1D)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Insulin (circadian)
Insulin (flat rate)
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes
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
Sites / Locations
- Imperial College Clinical Research Facility
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
circadian insulin infusion rates
flat rates
Arm Description
Initial 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 basal rate
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04267770
First Posted
February 11, 2020
Last Updated
March 19, 2020
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT04267770
Brief Title
Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion
Acronym
FIRST1D
Official Title
A Study of Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion (CSII) in Adults With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Initiation of insulin pump therapy in people with type 1 diabetes requires conversion of a basal insulin dose, given as once or twice daily long-acting insulin, to a continuous basal infusion regimen. This conversion may be based on basal insulin dose only, or total daily insulin dose, and may result in a flat basal insulin profile or an initial variable basal rate.
Initial 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. Initial rates were developed from 63 well-controlled people with type 1 diabetes over 14 years of age and have been assessed against a flat basal rate in a small randomised controlled trial with 12 participants. Mean glucose was lower in the circadian basal rate group with particular differences noted in the early morning when glucose rises were more pronounced in the flat basal rate group1.
In 50 people with type 1 diabetes treated with insulin pump therapy, HbA1c was lower in those with lower basal rates at midnight, and in those with higher basal rates in the afternoon, suggesting a benefit of circadian patterns2. In 33 people with type 1 diabetes over 16 years of age basal rate distribution established at commencement of pump therapy did not alter over 6 months3. However, a 6 month cross-over study of circadian rates and oligophasic basal rates showed no difference in HbA1c4.
Following initiation on insulin pump therapy basal rates are personalised to capillary blood and continuous interstitial fluid glucose monitoring.
In adults with type 1 diabetes starting insulin pump therapy there are limited data to guide the optimal insulin profile to rapidly achieve target glucose and minimise healthcare professional input.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
circadian insulin infusion rates
Arm Type
Experimental
Arm Description
Initial 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.
Arm Title
flat rates
Arm Type
Active Comparator
Arm Description
flat basal rate
Intervention Type
Drug
Intervention Name(s)
Insulin (circadian)
Intervention Description
Participant's own insulin adjusted to circadian infusion rates
Intervention Type
Drug
Intervention Name(s)
Insulin (flat rate)
Intervention Description
Participant's own insulin set to flat basal rates
Primary Outcome Measure Information:
Title
Change in Basal Insulin Rate
Description
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)
Time Frame
over 24 hours after 3 rounds of basal rate testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Imperial College Clinical Research Facility
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion
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