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Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion (FIRST1D)

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ClinicalTrials.gov Identifier: NCT04267770
Recruitment Status : Completed
First Posted : February 13, 2020
Results First Posted : March 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Insulin (circadian) Drug: Insulin (flat rate) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Study of Flat and Circadian Insulin Infusion Rates in Continuous Subcutaneous Insulin Infusion (CSII) in Adults With Type 1 Diabetes
Actual Study Start Date : April 10, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: circadian insulin infusion rates
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.
Drug: Insulin (circadian)
Participant's own insulin adjusted to circadian infusion rates

Active Comparator: flat rates
flat basal rate
Drug: Insulin (flat rate)
Participant's own insulin set to flat basal rates




Primary Outcome Measures :
  1. Change in Basal Insulin Rate [ Time Frame: over 24 hours after 3 rounds of basal rate testing ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267770


Locations
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United Kingdom
Imperial College Clinical Research Facility
London, United Kingdom
Sponsors and Collaborators
Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04267770    
Other Study ID Numbers: 17HH4255
First Posted: February 13, 2020    Key Record Dates
Results First Posted: March 31, 2020
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs