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NCT Number: NCT00360984

Prevention of Severe Hypoglycemia in Type 1 Diabetes

Severe hypoglycaemia leading to collapse without warning is one of the most-feared complications for those with Type 1 diabetes. The aim of this study is to determine whether detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1 diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia; or continuous subcutaneous insulin infusion. Symptomatic experience and severity of hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals, response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It is envisaged that successful prevention of hypoglycaemia by one or more interventions may reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Newcastle Diabetes Centre

Newcastle, Tyne and Wear, NE4 6BE, United Kingdom

About this study

The unifying objective of the proposed unblinded randomized prospective study is to determine whether hypoglycaemia awareness in Type 1 diabetes can be restored by rigorous avoidance of hypoglycaemia addressed by one of the following interventions:

  • A non-targeted approach whereby pre-prandial glycaemic targets are raised from 4.5-7mmol/L to 7.2-8.3mmol/L and hypoglycaemia is rigorously avoided without specific alterations in subcutaneous insulin regime5
  • Optimisation of subcutaneous insulin regime employing pre-prandial short-acting insulin analogue in combination with once daily insulin Glargine targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
  • Insulin delivery by external pump (continuous subcutaneous insulin infusion) targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 1 diabetes
  • recurrent severe hypoglycemia within the preceding 6 months
  • attending the Newcastle Diabetes Centre

Exclusion criteria

  • previous use of rapid- and long-acting insulin analogs used in an multiple daily insulin injection regimen
  • previous use of continuous subcutaneous insulin infusion pump
  • alcohol or drug abuse
  • seizures unrelated to hypoglycemia.

Treatment and study plan

insulin glargine

Drug

Continuous Subcutaneous Insulin Infusion

Device

Primary outcomes

  1. prevention of severe hypoglycemia

Secondary outcomes

  1. incidence of mild symptomatic hypoglycemia

  2. HbA1C

  3. Continuous Subcutaneous Glucose Monitoring System profiles

  4. Altered Hypoglycemia Awareness survey

  5. Hypoglycemia Fear Survey

  6. Diabetes Quality Of Life of questionnaires.

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Collaborators

  • Medtronic
  • Newcastle Primary Care Trust
  • Newcastle-upon-Tyne Hospitals NHS Trust
  • Sanofi

Registry information

Official study title

Can Hypoglycaemia Awareness Be Restored in Individuals With Type 1 Diabetes and Severe Hypoglycaemia Employing Optimised Subcutaneous Insulin Regime or Continuous Subcutaneous Insulin Infusion Pump

Important dates

Study start
2003
Study completion
2004
First posted
Aug 7, 2006
Registry last updated
Aug 7, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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