| Methods |
DESIGN: Randomised controlled trial
SETTING: Outpatient follow‐up
COUNTRY: USA
DURATION OF INTERVENTION: unclear, possible 12 months
ALLOCATION TO GROUPS: sequence generated from a table of random numbers
ANALYSIS BY INTENTION TO TREAT: yes |
| Participants |
INCLUSION CRITERIA: diabetes with an active prescription for a hypoglycaemic agent
EXCLUSION CRITERIA: >75 years old, mentally ill, life expectancy <12 months, newly diagnosed, planned to discontinue receiving care from clinic within 12 months, no touch telephone
NUMBERS:
Intervention: 146
Control: 146
GENDER (male/female): Intervention: 126/6
Control: 138/2
ETHNIC GROUPS:
Intervention: 71 White, 32 Black, 18 Hispanic, 11 Other Control: 93 White, 17 Black, 16 Hispanic, 15 Other
MEAN AGE:
Intervention: 60 (SD 10) Control: 61 (SD 10)
BASELINE MEASUREMENTS:
HbA1c:
Intervention: 8.2% (SD 1.7) Control: 8.1% (SD 1.7)
Hyperglycaemic symptoms: Intervention: 1.6 (SD 1.5) Control: 1.5 (SD 1.4)
Hypoglycaemic symptoms: Intervention: 1.3 (SD 1.3) Control: 1.2 (SD 1.6)
TYPE OF DIABETES: not stated
DURATION OF DIABETES: not stated
LOSSES TO FOLLOW‐UP: 20 in total (Intervention 14 and Control 6) |
| Interventions |
INTERVENTION: Automated telephone disease management calls, 5‐8 minutes, to record self monitoring of blood glucose readings, self‐care activities, perceived glycemic control, symptoms and use of guideline‐recommended medical care. Option to hear health promotion message. Nurses reviewed automated reports weekly, and followed up with calls. Nurse had ability to schedule clinic appointments. Nurse did not have ability to authorise medication changes, but recommended dosage adjustments to patient's primary care physician.
CONTROL: no description given. Methods reported to be similar to those in previous publications where follow‐up visits were provided at discretion of providers.
LENGTH OF FOLLOW‐UP: 12 months |
| Outcomes |
PRIMARY:
‐ HbA1c
‐ Hypoglycemic symptoms
‐ Hyperglycemic symtoms |
| Notes |
QUALITY ASSESSMENT: one or more criteria met
COMMENTS: Far more diabetic outpatient visits in intervention group. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
