N/A
Completed N=40
Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data
Type 1 Diabetes Mellitus With Hypoglycemia · Impaired Awareness of Hypoglycemia · Type1diabetes
Source: ClinicalTrials.gov NCT03028220 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL) — -3.0; 1.3 percentage of time <3.3mmol/l — p=0.01
Summary
This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL) |
-3.0; 1.3 | 0.01 sig |
| SECONDARY % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL) |
-1.2; 1.3 | <0.01 sig |
| SECONDARY % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL) |
-2.7; 0.6 | <0.01 sig |
| SECONDARY % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) |
10.6; 5.9 | 1.00 |
| SECONDARY % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL) |
12.7; 5.3 | 1 |
| SECONDARY % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL) |
-8.6; -7.0 | 0.820 |
| SECONDARY % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL) |
-4.9; -3.1 | 0.820 |
| SECONDARY Hypoglycemia |
0; 0 | 0.570 |
| SECONDARY Severe Hypoglycaemia |
0; 0 | <0.01 sig |
| SECONDARY Changes in Glucose Variability Measured |
-0.1; 0.0 | 0.910 |
| SECONDARY Glucose Variability Measured by MAGE |
-1.5; -0.4 | 0.460 |
| SECONDARY Glucose Variability Measured by CONGA |
0.1; 0.1 | 0.191 |
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years of age
- Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide 6 months (MDI)
- Previous type 1 diabetes structured education (either group or 1:1)
Exclusion Criteria
- Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)
- Use of regular paracetamol
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials, except at the discretion of the chief investigator
- Have active malignancy or under investigation for malignancy
- Severe visual impairment
- Reduced manual dexterity
- Unable to participate due to other factors, as assessed by the Chief Investigators
Data sourced from ClinicalTrials.gov (NCT03028220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.