Type 2 Diabetes Clinical Trial
— DOTTOfficial title:
The Effect of Treatment of Obstructive Sleep Apnea on Diabetes Self Management and Glycemic Control
Verified date | August 2021 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Diabetes self-management is important to help adults with type 2 diabetes achieve glucose control. Obstructive sleep apnea often co-exists with type 2 diabetes and may act as a barrier to diabetes self-management and glucose control. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP), combined with diabetes education, results in improved diabetes self-management and glucose control.
Status | Terminated |
Enrollment | 98 |
Est. completion date | May 8, 2019 |
Est. primary completion date | May 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Suboptimal glucose control (A1C = 6.5%) - Moderate-to-severe obstructive sleep apnea (apnea + hypopnea index >= 10/hour) - age 18 years and older Exclusion Criteria: - Poor glucose control (A1C > 11) - Type 1 or gestational diabetes - Sleep duration < 4 hrs - Acute medical or surgical conditions or hospitalization = 3 months - Oxygen or bi-level PAP required - Prior CPAP or persons in household with CPAP - Employed in safety sensitive job - Pregnant |
Country | Name | City | State |
---|---|---|---|
United States | John D. Dingell VAMC | Detroit | Michigan |
United States | West Virginia University | Morgantown | West Virginia |
United States | Pittsburgh Veterans Administration Medical Center | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Eileen R. Chasens |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1C Level | Glycated hemoglobin test that estimates the blood glucose level over last 2 to 3 months. Higher scores indicate worse diabetes control. | baseline, 6 weeks, 12 weeks | |
Secondary | Fructosamine Level | Measurement of glucose in plasma that estimates the blood glucose level over last 10 days to 3 weeks. The normal range is from 221.00 to 451.00. | baseline, 6 weeks, 12 weeks | |
Secondary | Diabetes Diet Adherence | Diabetes Diet Adherence score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that was adherent to diabetes diet, range from minimum=0 days to maximum=7 days; higher number indicates better adherence to diabetes diet | baseline, 6 weeks, 12 weeks | |
Secondary | Diabetes Knowledge | Score on the Diabetes Knowledge Test. Scores range minimum=0 to maximum=100, higher scores indicate higher knowledge (this measure only done at 12 weeks) | baseline,12 weeks only | |
Secondary | Self-Monitoring of Blood Glucose (SMBG) | SMBG score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that SMBG was done, range from 0 days to 7 days; higher number indicates better SMBG | baseline, 6 weeks, 12 weeks | |
Secondary | Steps Walked | Average number of steps walked daily; measured by BodyMedia Armband; higher numbers indicate more steps walked. The range is from 397.83 to 16839.00. | baseline, 6 weeks, 12 weeks | |
Secondary | Self-Monitoring of Foot Care | Foot Care score from the Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire, Average number of days each week that foot care was done, range from 0 days to 7 days; higher number indicates better adherence to foot care | baseline, 6 weeks, 12 weeks | |
Secondary | Diabetes-Related Distress | Score of the Problem Areas in Diabetes (PAID) Questionnaire; scores range from 0-100, higher scores indicate worse diabetes-related distress. | baseline, 6 weeks, 12 weeks | |
Secondary | Sleep Quality | Sleep Quality is measured by the Pittsburgh Sleep Quality Index (PSQI) - Higher scores indicate worse sleep quality. The potential range is from 0 to 27 with higher scores indicating worse sleep quality. | baseline, 6 weeks, 12 weeks | |
Secondary | Mood | Mood impairment measured by the Profile of Mood States (POMS) total score; potential scores range from 0 to 60; higher scores indicate worse mood. | baseline, 6 weeks, 12 weeks | |
Secondary | Vigilance | Ability to maintain attention (i.e. vigilance); Measured by the Psychomotor Vigilance Test primary metric being transformed lapses (i.e. when person does not respond to a visual stimuli in a reaction time test). Normal values are <=2 lapses within the 10 minute test. Higher scores indicate worse vigilance. | Administered during diabetes education sessions done within the first 6 weeks of study; baseline, approximately 3 weeks after starting CPAP, and at the 2nd diabetes education session |
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