Obstructive Sleep Apnea, Pre-diabetes
Conditions
Brief summary
The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.
Detailed description
Glucose metabolism in patients newly diagnosed with moderate-severe OSA and without diabetes will be monitored for two weeks prior to commencement of CPAP using a CGM. They will consume a 75g oral glucose drink fasted on waking twice during the two-week monitoring period, having consumed a standardised meal the evening prior. After establishing CPAP use for at least four weeks they will undergo the same protocol as for the observation period prior to commencing CPAP. Glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.
Interventions
DEVICECPAP
A positive CPAP intervention
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Community dwelling adult males and females aged 18-65 years 2. Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) ≥15/hr within the past 60 months 3. Able to give written informed consent 4. Proficient in English 6\. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (\<3 months) findings: 1. Fasting glucose with a BGL \<7.0 mmol/L 2. Glucose tolerance with a 2-hour BGL of \< 11.1 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT) 3. HbA1C of ≤ 6.5% 7. Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.
Exclusion criteria
1. Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury) 2. Severe mental health disorders (e.g. current major depressive disorder, schizophrenia, bipolar disorder) that in the opinion of the investigator is not adequately treated or will significantly affect their participation in the study. 3. Regular (\>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants) 4. Regular night shift work or travel overseas within the last 2 weeks 5. Sleep physician has advised against CPAP withdrawal 6. Pregnancy 7. Active smoking or routine alcohol use (more than 2 standard drinks a day) or excessive caffeine intake (\>300 mg a day) or recent (in the past month) use of illicit drugs 8. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded) 9. Current or recent (\<3 months) use of hypoglycaemic agents 10. Undergoing a weight loss programme 11. Contraindications for use of the FreeStyle Libre Pro Sensor. E.g. Known hypersensitivity to skin adhesives such as those used to attach the sensor to the arm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean 24 hour glucose difference between the CPAP on and CPAP off conditions | 2 weeks | Average 24 hour glucose difference between CPAP on and CPAP off conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extended hypoglycaemic event rate | 2 Weeks | Number of events with sensor glucose \<3.9 mmol/L lasting at least 120 min, event ends when glucose returns to at least 3.9 mmol/L for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Extended Hypoglycaemia | 2 Weeks | Number of times CGM sensor values are \<3.9 mmol/L for at least 120 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| High Glucose Level (Level 1) | 2 Weeks | Number of times CGM sensor values are 10.1-13.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 10 mmol/L. |
| Very High Glucose (Level 2) | 2 Weeks | Number of times CGM sensor values are \>13.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 13.9 mmol/L. |
| Extended Hyperglycaemia | 2 Weeks | Number of times CGM sensor values are \>13.9 mmol/L for at least 90 consecutive minutes within a 120-minute period during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Mean daytime glucose difference between the CPAP on and CPAP off conditions | 2 weeks | Mean Daytime (6:00 AM - 10:00 PM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Mean night time glucose | 2 weeks | Mean Night-time (10:00 PM - 6:00 AM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Glucose tolerance | 2 weeks | Difference in glucose tolerance as measured by peak 2-hour post 75g glucose load administered twice during each two-week observation period using a CGM |
| Coefficient of Variation | 2 Weeks | Percentage CV intraday (i.e. within 24h) and interday (i.e. over multiple days) between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| SD of Mean Glucose | 2 Weeks | SD of Mean Glucose (daily) during the CPAP on and CPAP off conditions during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Time in Range (TIR) | 2 Weeks | Percentage of TIR (3.9-10.0 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Time Below Range (TBR) | 2 Weeks | Percentage of TBR (3.9 mmol/L including readings of \<3 .0 mmol/L) during the the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Time below Range <3.0 mmol/L | 2 Weeks | Percentage of TBR \<3.0 mmol/L (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Time Above Range (TAR) | 2 Weeks | Percentage of TAR (\>10.0 mmol/L, including readings \>13.9 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Time Above Range >13.9 mmol/L | 2 Weeks | Percentage of TAR \>13.9 mmol/L (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Time in Tight Range (TITR) | 2 Weeks | Percentage of TITR (3.9-7.8 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Change in Glucose Management Indicator | 2 Weeks | Absolute main change in mmol/L or percentage during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Extended hyperglycaemic event | 2 Weeks | Number of events with sensor glucose \>13.9 mmol/L lasting at least 120 min; event ends when glucose returns to 10 mmol/L or less for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TIR >70% | 2 Weeks | Proportion of participants with TIR 3.9-10.0 mmol/L for \>70% of the day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TIR improvement at least 5% | 2 Weeks | Proportion of participants with TIR 3.9-10.0 mmol/L with at least a 5% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TIR improvement at least 10% | 2 Weeks | Proportion of participants with TIR 3.9-10.0 mmol/L with at least a 10% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TBR <3.9 mmol/L <4% | 2 Weeks | Proportion of participants with TBR \<3.9 mmol/L for \<4% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TBR <3.0 mmol/L <1% | 2 Weeks | Proportion of participants with TBR \<3.0 mmol/L for \<1% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TAR >10.0 mmol/L >25% | 2 Weeks | Proportion of participants with a TAR \>10.0 mmol/L for \<25% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TAR >13.9 mmol/L <5% | 2 Weeks | Proportion of participants with TAR \>13.9 mmol/L for \<5% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Hypoglycaemia | 2 Weeks | Number of times CGM sensor values are \<3.9 mmol/L (including readings of \<3.0 mmol/L) for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol/L. |
| Hypoglycaemia Alert Value (Level 1) | 2 Weeks | Number of times CGM sensor values are 3.0-3.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol/L. |
| Clinically Significant Hypoglycaemia (Level 2) | 2 Weeks | Number of times CGM sensor values are \<3.0 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.0 mmol/L. |
Other
| Measure | Time frame | Description |
|---|---|---|
| TIR >70% and <1% TBR <3.9 mmol/L | 2 Weeks | Proportion of participants with \>70% TIR 3.9-10.0mmol/L and \<4% TBR \<3.9 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TIR >70% and < 1% TBR <3.0 mmol/L | 2 Weeks | Proportion of participants with \>70% TIR 3.9-10.0 mmol/L and \<1% TBR \<3.0 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| TIR Improvement >10% and <0.5% increase in TBR <3.0 mmol/L | 2 Weeks | Proportion of participants with \>10% improvement in percentage of TIR 3.9-10.0 mmol/L without an increase in the TBR \<3.0 mmol/L of \>0.5% during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
| Mean Glucose <8.6 mmol/L and <1% TBR <3.0 mmol/L | 2 Weeks | Proportion of participants with Mean Glucose \<8.6 mmol/L and \< 1% TBR \<3.0 mmol/L during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. |
Countries
Australia
Contacts
Primary ContactDavid J Sherring, MBBS, DClinD
Outcome results
None listed