| Methods |
In 38 people with diabetes and 20 controls, symptoms and neurophysiological examinations including electroneurography, vibration perception and temperature discrimination thresholds were investigated. Participants were randomized to insulin (n = 18) or sulfonylurea (n = 16) treatment and were re‐investigated after 1 year. |
| Participants |
40 elderly type 2 diabetic patients who attended a healthcare center. 22 women and 18 men (mean age 75.2 years, range 67 to 86 years and mean height 1.66 m, range 1.45 to 1.81 m) with secondary failure of oral antidiabetic drug therapy but without symptoms of hyperglycemia. |
| Interventions |
One group was put on insulin (insulin‐treated, n = 20) and a district nurse showed them how to monitor the blood glucose levels regularly and to administer injections. Adjustments in doses were made until the blood‐glucose reached levels of 6 to 12 mmol/L during the day. Participants received 0.52 (0.27) units (mean and SD) of insulin per kg body weight and day. The other group (sulfonylurea‐treated, n = I6), was kept on high doses of sulfonylurea, i.e. 7 to 10.5 mg glibenclamide or 10 to 15 mg glipizide per day. |
| Outcomes |
On the initial examination and after 12 months, participants were asked if they experienced numbness, weakness or pain in the legs or arms. Their feet were inspected for ulcers. The Achilles tendon jerks were assessed and vibration sensation was tested with a tuning fork (128 Hz) on each medial malleolus and great toe. Electroneurography in motor and sensory nerves were performed on the median, ulnar, peroneal, and sural nerves on one side. Vibration perception was tested at the dorsum of the second metacarpal bone of one hand and the first metatarsal bone of one foot with an electromagnetic vibrameter. Thresholds for temperature discrimination were determined with the method described by Fruhstorfer, employing a Peltier element placed on the palm of one hand and the dorsum of one foot. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomly divided otherwise not stated in methods |
| Allocation concealment (selection bias) |
Unclear risk |
Not clearly stated in methods |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not clearly stated in methods |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
2 participants were excluded prior to examination and 4 after (2 versus 2) |
| Selective reporting (reporting bias) |
High risk |
They report only differences between diabetics and non‐randomized controls but not between participants |
| Other bias |
Low risk |
None |
