Type 1 Diabetes Clinical Trial
Official title:
Investigation of Appropriate Timing of Additional Insulin Dosing for Fat and Protein in Children With Type 1 Diabetes Using Multiple Daily Injections
The aims of the study are to see if additional insulin doses for the fat and protein in a meal, given at different times, improve blood glucose levels and are safe and acceptable to children with Type 1 diabetes using multiple daily insulin injections.
The study design is a repeated measures study involving the provision of a standard high
protein/high fat evening test meal on 3 different evenings within a 7-day period in the same
study subject. The children/adolescents will be instructed to give an insulin dose for the
carbohydrate before the meal (calculated using their optimal insulin to carbohydrate (ICR) -
20%). In addition they will have an additional dose for the fat and protein content either
before (together with the dose for the carbohydrate in the meal [control meal]), 1 hour
after, or 2 hours after the meal. These will be carried out in a random order in each
subject. Continuous glucose monitoring (CGM) will be carried out for the whole 7 day period.
Questionnaires will assess the acceptability to young people and their parents of the extra
insulin doses.
After an initial contact in the clinic, and provision of patient information leaflets, the
research nurse or dietitian will telephone the patient and family after a week to answer any
questions they may have about the study. If they are keen to participate, an appointment will
be arranged for consent and to commence the study (Visit 1).
At Visit 1 the investigators will obtain informed consent and commence a week-long run-in
period for participants to optimise insulin to carbohydrate ratio at the evening meal. During
this week subjects will be requested to test capillary blood glucose (BG) levels at 7 points
throughout the day (pre-meals, 2 hrs after meals and bed). They will be asked to eat a fat
and protein free meal on one of these days. If necessary, adjustments to the insulin to
carbohydrate ratio (ICR) or long-acting insulin doses will be made over the telephone by an
experienced member of their clinical team. This is to decrease the likelihood of a correction
bolus for a high BG level being required at the evening meal during the study week.
At the end of the run-in week, participants will then attend the outpatient clinic or day
care ward research facility at the Oxford Children's Hospital or the Horton Hospital
outpatient clinic in Banbury or the Royal Berkshire Hospital in Reading (Visit 2). At this
visit, the subcutaneous glucose sensor will be inserted by the research nurse and children
and young people and their families will be trained on its use prior to the study commencing.
CGM records glucose levels every 5 minutes over 7 days and thus provides much more
information than routine capillary BG testing. It also alarms to alert patients of high and
low glucose levels. Children and young people will also record their BG levels from routine
finger pricks, pre-prandially and before bed and on waking in the morning.
Also at Visit 2, the study dietitian will review BG readings and food diary from the previous
week and optimise ICR doses of rapid acting insulin. This ratio will then be used to
calculate insulin doses for the study meals. On three evenings over the next 7 days, the
children will eat a standard high protein/high fat meal. The evenings will not be set, but
will depend on the child and family schedule. The child and family will be able to choose
which days during the study period on which they complete the study meals but will be advised
to avoid days when the participant has undertaken lots of exercise, has had frequent
hypoglycaemic episodes or has been unwell.
The standard meal will be a portion controlled gluten-free meal provided and delivered by
Wiltshire Farm Foods consisting of a meat-based main course and dessert. These will be kept
frozen until used by participants and prepared according to manufacturer instructions. These
meals come in two sizes which allow portion sizes to be adjusted for different ages of child,
but the proportions of fat, protein and carbohydrate will be kept constant for each child,
and by definition the meals will be high in protein and high in fat.
Insulin doses with the standard meal will be given according to calculations carried out by
the dietitian and administered in one of three ways.
The three evenings in random order will be as follows:
1. Insulin units based on ICR minus 20%, and fat/protein dose given together immediately
before the meal [control meal].
2. Insulin units based on ICR minus 20%, given immediately before the meal plus extra
insulin for fat/protein units given 1 hour after the meal.
3. Insulin units based on ICR minus 20% given immediately before the meal plus extra
insulin for fat/protein units given 2 hours after the meal.
Full written instructions will be provided to the family for all aspects of the insulin
dosing for the study meals. During the study on the standardised meal days children will be
instructed not to eat any food after the meal during the evening, and not to correct any
later BG levels unless they are dangerously high (BG over 16 mmol/l with ketones over 0.5
mmol/l). If BG levels go low at any time (BG less than 4 mmol/l) children will be instructed
to treat the hypoglycaemia according to their usual management. This data will be analysed
separately. Children and families will be asked to complete diaries during the trial week.
At the end of the study period (the day after the third meal), children will come back to the
research facility or clinic for the end of study visit (visit 3). A research nurse or
dietitian will remove the CGM sensor and download the data onto a secure laptop. Children and
their families will then be asked to complete a short questionnaire about the acceptability
of using the extra insulin doses, and their perceptions as to whether there were any
beneficial or adverse effects.
The study dietitian will calculate standard outcomes from each patient's sensor download and
pass on anonymously to the study statistician to analyse the data.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Recruiting |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|
||
Completed |
NCT02914886 -
Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)
|
Phase 4 |