Hypoglycemia, Reactive

Hypoglycaemia Night

Hypoglycemia Non-Diabetic

Hypoglycemia Unawareness

Insulinoma

Insulinoma; Malignant, Pancreas

Insulin Hypoglycemia

Insulin Resistance

Spontaneous Hypoglycemia

Neuro Endocrine Tumours

Patients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication.

use of continuous glucose monitoring

St Bartholomew's Hospital, dept of endocrinology

CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia

Continuous Glucose Monitoring: An Evaluation of Impact on Improving the Efficiency of Diagnostic Processes and Enhancing Patient Safety in the Management of Reactive and Spontaneous Hypoglycaemia

outpatient - CGM findings reflect patient's fingerprick glucose readings
Episodes of true hypoglycaemia (glucose measurement <4, <3.0, <2.2mmol/L as decided by finger prick glucose testing) are captured by the CGM device

inpatient - CGM findings reflect patient's fingerprick glucose readings
Episodes of true hypoglycaemia (glucose measurement <4, <3.0, <2.2mmol/L, as decided by finger prick glucose testing) are captured by the CGM device Inpatient - 72 hour fast - CGM device calls hypoglycaemia (glucose measurement <4, <3.0, <2.2mmol/L) when fingerprick/lab glucoses also do

blinded phase - CGM findings reflect patient's fingerprick glucose readings- any episodes of true hypoglycaemia (as decided by fingerprick glucose testing) are captured by CGM device unblinded phase - CGM recordings help with titration of anti hypoglycaemic medications and this reduces overall incidence of hypoglycaemic episodes or duration of time spent in hypoglycaemic range (<4, <3.0, <2.2 mmol/L)

To determine whether CGM systems accurately record hypoglycaemia and can be used in this context

Barts & The London NHS Trust

2 phases to study. Patients can enter at start of either phase and start phase 2 at the end of phase 1.
Phase 1 - CGM monitoring of people with suspected spontaneous/reactive hypoglycaemia phase 2 - CGM monitoring of patients with medically managed spontaneous/reactive hypoglycaemia

Phase 1 - (diagnostic) The CGM device will be blinded to the patient and physician until investigations into hypoglycaemia are complete phase 2 - (treatment optimisation) The CGM device will be blinded to the patient and physician for the first 10 days of treatment, medication will be optimised and the patient will continue with CGM in an unblinded way for up to 20 further days to aid further treatment optimisation

Sucralose 48 mg in 60 ml of water O.D. for ten weeks

sucralose 96 mg in 60 ml of water O.D. for ten weeks

60 ml of water as placebo O.D. for ten weeks

Healthy

volunteers will take sucralose or placebo daily for 70 days

sucralose 48 mg (splenda)/day for ten weeks

Serum Insulin Response After Acute and Chronic Sucralose Ingestion in Healthy Volunteers With Variable Body Mass Index

Effect of Acute or Chronic Ingestion of Sucralose on Serum Insulin in Young and Healthy Adults: a Randomized, Double-blind, Placebo-controlled Trial

To assess the effect of acute and chronic exposure to different sucralose concentrations differentiating the area under the curve levels in healthy, young volunteers, at a glucose tolerance test of 180 minutes.

To assess the effect of acute and chronic exposure to different sucralose concentrations.

To assess the effect of chronic exposure to different sucralose concentrations.

Influence of Body Mass Index on the glucose mean area under the curve levels with different sucralose concentrations.

Influence of Body Mass Index on the C-peptide mean area under the curve levels with different sucralose concentrations.

Influence of Body Mass Index on the glucagon mean area under the curve levels with different sucralose concentrations.

Influence of Body Mass Index on the GLP-1 mean area under the curve levels with different sucralose concentrations.

Influence of Body Mass Index on the glucose-dependent insulinotropic polypeptide mean area under the curve levels with different sucralose concentrations.

Guillermo Melendez

Projects record and follow-up chief

Hospital General de México Dr. Eduardo Liceaga

Recombinant human intranasal insulin formulation in a buffered solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product is formulated at a dose strength of 1100 IU / mL (40mg/mL) manufacturing formulation. The product will be self administered by eligible participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.

Placebo insulin carrier solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product will be self administered by participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.

Type 1 Diabetes

Intranasal insulin

Placebo insulin carrier solution containing benzalkonium chloride and glycerol

Placebo

The Children's Hospital at Westmead

Mater Children's Hospital

Womens and Childrens Hospital

Royal Melbourne Hospital

Princess Margaret Hospital

University of Auckland

Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes

A Randomised, Double-blind, Placebo-controlled Trial of Intranasal Insulin (440 IU) in Children and Young Adults at Risk of Type 1 Diabetes: Intranasal Insulin Trial II

Defined as the presence of 2 or more of the following diagnostic criteria including diabetic fasting blood glucose level, diabetic 2 hour postprandial blood glucose level, diabetic HbA1c and symptoms

Measured as glucose and insulin responses in Oral glucose tolerance test (OGTT) 6 monthly

Insulin resistance measured by Homeostasis of model assessment - resistance (HOMA-R) 6 monthly

Measured by levels of circulating antibodies to insulin, Glutamic acid decarboxylase (GAD) and Tyrosine phosphatase - like insulinoma antigen (IA-2) and T cell responses to proinsulin, denatured insulin, GAD and tetanus at 5 years

insulinoma/سمنة

CGM (Continuous Glucose Monitoring) Use in Diagnosis of Spontaneous and Reactive Hypoglycaemia

Serum Insulin Response After Acute and Chronic Sucralose Ingestion in Healthy Volunteers With Variable Body Mass Index

Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes

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